Remote - Clinical Data Engineer / Clinical Data Analyst with SQL, SSRS, SQL Server, Power BI, EHR
Amtex Systems Inc. 4.0
Remote job
Need 10+ Years experience
ClinicalData Analyst
Remote
12 Months+
Microsoft stack foundation (Power BI, SQL, SSRS, SQL Server) with a focus on front-end analytics, data extraction, and delivering insights to leadership.
Lead data extraction, modeling, and SQL-based analysis supporting clinical and operational initiatives
Build and present KPI dashboards, scorecards, and visualizations using Power BI
Work with claims, EMR/EHR, and insurance datasets to drive insights on quality, financial performance, and operational efficiency
• Strong Power BI, SQL/SSRS/SQL Server foundation
$68k-84k yearly est. 3d ago
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Clinical Data Associate
Loyal 4.7
Remote job
Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.
We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.
Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.
About the role
We're seeking an experienced ClinicalData Associate that is responsible for configuring and maintaining Electronic Data Capture (eDC) systems across our veterinary clinical trials. The role requires someone who is familiar with veterinary clinical trials, highly organized, and thrives on understanding complex workflows to create clear, structured solutions that support regulatory-compliant, audit-ready data collection and trial execution.
You will be reporting to our Senior Project Manager.
Your daily work will include:
Designing, configuring, testing, and supporting eDC systems that meet the data collection needs of study protocols, from exploratory to pivotal clinical trials.
Influencing study design, data capture, and compliance with Good Clinical Practice (GCP) standards and FDA/CVM regulations.
eDC builds that include novel or complex design requirements, navigate challenging concepts, and prioritize usability for our clinical team and veterinary hospitals.
Validation of system, edit checks, derivations, and custom logic through User Acceptance Testing (UAT) to release.
Monitoring in-life study database, troubleshooting inconsistencies or system issues, and supporting mid-study updates in collaboration with our clinical team.
Conducting training and developing tools to ensure seamless onboarding and support for study teams and veterinary sites.
Maintaining thorough documentation, validation reports, and data dictionaries.
Collaborating daily with Clinical Development, Clinical Operations, Data Science and Engineering, Quality, and Regulatory teams, and serving as the primary point of contact between Loyal and external eDC vendor(s).
Embracing a culture where ideas are shared freely, feedback is welcomed early and often, and solutions are shaped through iterative, cross-functional input to ensure systems are both effective and user-centered.
About you:
Bachelor's degree or equivalent experience in life sciences, engineering, data management, or a related field.
Minimum 2 years experience in clinical trials (preferably veterinary) and a proficient understanding of data integrity and GCP.
Must have a process-driven mindset with a deep appreciation for UX/UI and a meticulous attention to detail with a tendency toward quality control.
Comfortable exploring AI-powered tools and other emerging technologies to support clinicaldata system integration.
Familiar with the unique operational nuances and limitations inherent to veterinary medicine, with experience in veterinary clinical practice preferred.
Competent and independent, with strong analytical skills and the ability to think logically through workflows, and provide context on dependencies and limitations in light of study design or data collection methods.
Demonstrates a proactive, flexible, and curious approach to problem-solving, with a comfort level in navigating ambiguity and a willingness to raise issues early to keep trials running smoothly and thoughtfully.
Must be able to communicate ideas and feedback effectively, merging and managing eDC timelines alongside company timelines and collaborating cross-functionally.
Salary: $90,000 - $120,000
Loyal benefits:
Full-coverage health insurance - medical, dental and vision - for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends 🎉
Unlimited vacation and paid holidays
Paw-ternity leave - adopt a dog and get a day off with your new family member 🐶
Competitive salary
Company equity options grant for new hires
Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.
Our values Lean into moonshots
We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
Opportunity is at the intersection
We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Expertise without ego
Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.
Learning by doing
Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
Lead with context
We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.
Empathy and respect for all life
Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
$90k-120k yearly Auto-Apply 3d ago
Manager, Clinical Data Management
Perceptive 4.1
Remote job
Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.
We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together.
Are you ready to help change the world?
Apart from job satisfaction, we can offer you:
HEALTH:
- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)
YOURSELF:
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings
WEALTH:
401(k) program, life & accident insurance and disability insurance
About the role
As Manager, ClinicalData Management, you will oversee and work alongside a team of end-to-end data custodians and will play a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. In this role, you will create data management standard operating procedures and help define overall process and training for ClinicalData Management staff in accordance with SCDM best practices and applicable regulatory requirements. This is a working manager position requiring strong managerial and interpersonal skills alongside hands-on application of skills.
Key Responsibilities
Leadership and Team Management
Leads, mentors and develops a clinicaldata management team through direct line management.
Provides training on Data Management procedures.
Provides training and monitors performance to ensure the team are operating at the highest level to design and deploy clinicaldatabases for multiple clinical imaging studies.
Manages team workload and prioritization for all assigned staff.
Acts as resource manager for dedicated therapeutic area.
Sets clear goals, providing regular feedback and fostering a collaborative team environment.
Conducts one-on-one meetings.
Mentors and ensures the team adheres to best practices and industry standards and facilitates positive career growth.
Data Management
Creates study Data Management Plans and deployment roadmaps.
Oversees and participates in the design of study CRFs and databases utilizing eCRF library.
Provides guidance as clinicaldatabase development subject matter expert.
Monitors study timelines and communicates risk.
Acts as sponsor portfolio lead representative.
Oversees multiple concurrent projects.
Facilitates study team involvement in database development.
Utilizes metrics to monitor study health.
Communicates with sponsors and internal leadership regarding study data processes, endpoints, and overall data management process.
Process Oversight
Creates and maintains Standard Operating Procedures.
Provides guidance on Data Management best practices and regulatory considerations.
Defines new procedures and solutions for novel therapeutics and study endpoints.
Other
Carries out any other reasonable duties as requested.
Functional Competencies (Technical knowledge/Skills):
Excellent demonstrable knowledge of regulatory guidelines and requirements for clinicaldata management.
Displays excellent understanding of clinical trial data standards.
Understanding of clinical trial processes, protocols, and regulatory requirements (e.g., FDA guidelines) related to data management.
Excellent communication (oral and written) and interpersonal skills, to convey data-related information to technical and non-technical stakeholders (internal and external) including clients and research centres.
Excellent analytical skills with attention to detail and the ability to identify data discrepancies and trends.
Ability to manage multiple tasks and prioritize work in a fast-paced and deadline-driven environment, with the ability to raise potential issues with deliverables on time.
Detail oriented and possess excellent organizational skills.
Builds and maintains an up-to-date awareness of industry trends, best practices, and emerging technologies in data management for clinical research.
Ability to work collaboratively within a matrix team environment.
Ability to effectively motivate and guide team members towards shared goals.
Natural coach/mentor who leads by example with an approachable demeanour and visible leader skills.
A self-starter and able to work under own initiative.
Strong analytical and creative problem-solving skills to identify issues and propose solutions.
Displays technical project management skills and oversight.
Ability to manage task creation and tracking via ticketing software.
Demonstrates meticulous attention to detail, documentation and adherence to study protocols and standard operation procedures (SOPs).
Experience, Education, and Certifications:
Significant demonstrable practical work experience in a clinical or technical setting.
Line management experience.
Demonstrable experience in team settings to achieve goals.
Demonstrable experience and proficiency with clinicaldata management systems.
Experience working with research support or clinical team.
Proficiency in Microsoft Office Suite (Word, Excel (macros), PowerPoint) and data visualization tools is preferred.
Bachelor's Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science) or equivalent experience in a related field.
English: Fluent.
This role is remote. Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred.
The annual base salary range for this role is $85,282- $158,380. This range represents the anticipated initial annual salary and will vary depending on several factors.
Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
$85.3k-158.4k yearly Auto-Apply 42d ago
Help Desk-Clinical Data Analyst
La Pine Community Health Center
Remote job
You must be an Oregon Resident
The part-time Helpdesk Data Analyst will oversee the analytics help desk and related activities. The position will manage incoming requests, run requested reports, filter data, make report edits and enhancements and provide technical advice. This position will assist with maintenance and enhancement projects related to organization-wide data, reports, and systems. They will partner with stakeholders to analyze data and explore ways to increase efficiency, reduce parallel processes, grow end user tool adoption, expand access to cross-functional data, and improve the ability of our stakeholders to make data-driven decisions. As part of the quality improvement team, the helpdesk data analyst will collaborate with health center leadership and users to identify opportunities for efficiencies and improved health outcomes.
Responsibilities
This is a dual role, overseeing the analytics helpdesk and working in healthcare data analytics.
Monitor analytics helpdesk, field questions and complete analytics requests with excellent customer service and communication.
Quickly learn tools, processes and workflows while being responsive to stakeholders needs.
Use Software to retrieve and combine data in various reporting tools and perform data analysis.
Continuous review of existing reports for accuracy.
Identify, assess, and troubleshoot reporting issues. Communicate and escalate to vendors as necessary.
Collaborate with clinicaldata analyst on projects.
Assist population health team with projects.
Perform other duties as assigned.
Minimum Qualifications
High School graduate.
One year of relevant work experience.
Solid experience with Microsoft Office Suite (Excel, Outlook, Word, PowerPoint).
Exceptional customer service skills.
Ability to prioritize assigned tasks and responsibilities with minimal supervision.
Ability to demonstrate deadline and detail-oriented project and ticket completion.
Ability to manage multiple tasks. Must be organized and a self-starter.
Ability to work independently and to use good judgment.
Excellent oral and written communication skills.
Enthusiasm for working as a member of a team in a rapidly changing environment.
Strict adherence to HIPAA laws and regulations concerning confidentiality and security of protected health information.
Preferred Qualifications
Bachelor's degree in data analytics, computer science or related field
Experience with Epic electronic medical record
Financial and/or billing knowledge
Certification or professional training in IT or Health IT
Knowledge of OCHIN EPIC reporting suite, Power BI, Tableau and SQL database systems.
FQHC reporting/regulation standards (i.e., UDS, ACO, PCPCH, etc.)
Knowledge of Federally Qualified Health Centers
Physical Demands Required to Fulfill Essential Functions of this Position
Employee must be able to sit or stand for long periods of time. Employee must be able to focus on tasks while in an active office environment where conversation and noise is prevalent. Employee must be able to operate a keyboard, write, speak, and hear. Employee must be able to read small print both on paper and on a computer screen for long periods of time. Ability to occasionally lift up to 20 pounds.
Additional Requirements
Submit to and pass a drug test
Successfully complete a criminal background check
Must be able to work beyond normal working hours, including weekends.
Working Conditions
This part-time position will have the option to work remotely or in the office. There may be exposure to airborne and blood-borne pathogens, and hazardous materials.
Equal Employment Opportunity Statement
La Pine Community Health Center provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. La Pine Community Health Center complies with applicable state and local laws governing non-discrimination in employment in every location in which the organization has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfers, leave of absence, compensation, and training.
$62k-96k yearly est. Auto-Apply 60d+ ago
Clinical Documentation Specialist (Remote -Texas Resident) - Clinical Data
Aa083
Remote job
Clinical Documentation Specialist (Remote -Texas Resident) - ClinicalData - (2507161) Description Minimum Qualifications:· Certified Registered Health Information Administrator (RHIA), Technician (RHIT), or an associate degree in a healthcare-related discipline with Certified Coding Specialist (CCS) certification, and a minimum of 3 years of medical coding experience.
Or· Registered nurse (or medical school graduate) with a minimum of 3 years inpatient clinical experience, advanced clinical expertise and an extensive knowledge of complex disease processes with broad clinical experience in an inpatient setting.
Licenses, Registrations, or Certifications Required: RN current license or RHIA/RHIT/CCS (medical school graduates are exempt from this MQ) And Must acquire CCDS or CDIP certification within 3 years of hire Preferred Qualifications:For nurse candidates, one year of CDI experience is highly desirable.
Bachelor of Science in Nursing (BSN).
CCDS or CDIP Certification.
Job Summary:Scope: Responsible for the overall improvement of the quality and accuracy of medical record documentation through interaction with physicians, members of the patient care team, and hospital coding staff.
Function: Ensures clinical documentation accurately reflects the appropriate level of service provided, severity of illness, and risk of mortality of each patient.
Successfully facilitates the accurate representation of patient status that translates into coded data.
Job Duties:Concurrently review inpatient admissions to identify opportunities to clarify missing or incomplete documentation.
Collaborate with providers, case managers, coders, and other healthcare team members to facilitate comprehensive health record documentation that reflects clinical treatment, decisions, diagnoses, and interventions.
Understand the general flow of health information from medical record documentation and discharge, through coding, to billing, and finally to data reporting.
Utilize the hospital's designated clinical documentation system to conduct reviews of the health record and identify opportunities for clarification.
Apply knowledge of inpatient ICD-10 coding guidelines and clinical documentation requirements to assign working MS-DRG.
Enter review information and working MS-DRG/APR-DRG's with associated length of stay in the shared information system, and update this information as needed to reflect any changes in the patient's status, procedures, and treatments.
Communicate with providers either through discussion or in writing (e.
g.
, formal queries) regarding missing, unclear, or conflicting health record documentation for clarification.
Conduct follow-up of posted queries to ensure queries have been answered and physician responses have been appropriately documented.
Educate and communicate clinical documentation opportunities in the appropriate hospital venues for staff and physician learning opportunities.
Act as a consultant to coding professionals when additional information or documentation is needed to assign coded data.
Collaborate with HIM/coding professionals to review individual problematic cases and ensure the accuracy of final coded data in conjunction with CDI managers, coding managers, and/or physician advisors.
Assume responsibility for professional development by participating in workshops, conferences and/ or in-services.
Keep current with changes in coding guidelines, compliance, reimbursement, and other relevant regulatory updates.
Contribute to a positive working environment and perform other duties as assigned or directed to enhance the overall efforts of the organization.
Maintain positive and open communication with physicians, members of the patient care team, case management, and hospital coding staff.
Adhere to internal controls and reporting structure.
Comply with all relevant policies, procedures, guidelines, and other regulatory, compliance, and accreditation standards.
Performs related duties as required Knowledge/Skills/Abilities:Demonstrate excellent observation skills, analytical thinking, and problem-solving, plus good verbal and written communication.
Salary Range: $71,923.
00 to $115,077.
00, salary offers are based on a variety of factors, including but not limited to department budget, internal equity, experience, education, and expected job duties.
Work Schedule:Remote work, Texas resident preferred, Monday through Friday, 8 am to 5 pm, and as needed on occasion.
Qualifications Equal Employment OpportunityUTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law.
As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
Primary Location: United States-Texas-GalvestonWork Locations: 0752 - Clinical Science Bldg.
301 University Blvd.
Clinical Science Building, rm 306 Galveston 77555-0752Job: Medical AdministrativeOrganization: UTMB Health: RegularShift: StandardEmployee Status: Non-ManagerJob Level: Day ShiftJob Posting: Dec 17, 2025, 9:36:47 PM
$71.9k-115.1k yearly Auto-Apply 27d ago
Associate, Data Cloud Solutions
Zeta Global 4.5
Remote job
WHO WE ARE
Zeta Global (NYSE: ZETA) is the AI-Powered Marketing Cloud that leverages advanced artificial intelligence (AI) and trillions of consumer signals to make it easier for marketers to acquire, grow, and retain customers more efficiently. Through the Zeta Marketing Platform (ZMP), our vision is to make sophisticated marketing simple by unifying identity, intelligence, and omnichannel activation into a single platform - powered by one of the industry's largest proprietary databases and AI. Our enterprise customers across multiple verticals are empowered to personalize experiences with consumers at an individual level across every channel, delivering better results for marketing programs. Zeta was founded in 2007 by David A. Steinberg and John Sculley and is headquartered in New York City with offices around the world. To learn more, go to *******************
The Role
Zeta Global is seeking a Solutions Associate for our Data Cloud Applications team to drive operational excellence, client support, and solution innovation. This role provides critical leverage to the team by supporting projects related to knowledge sharing, operational execution, and strategic solution enhancement. The Solutions Associate will work closely with Zeta's key partners to help win new business, grow existing accounts, and maintain their competitive edge. They will have the autonomy to develop unique working models that best fit their strengths and workflow preferences while maintaining strong collaborating with the broader Zeta team and client stakeholders. The Solutions Associate will play a key role in informing Zeta's product roadmap by capturing client feedback and identifying opportunities for greater efficiency and effectiveness. Success in this role will be measured by the ability to deliver on critical client requests and contribute meaningfully to client satisfaction and long-term growth.
Roles & Responsibilities
Develop a comprehensive understanding of the Zeta Data Cloud Identity Graph, attributes, and signals to support audience curation and data-related inquiries
Demonstrate a deep understanding of Zeta's Opportunity Explorer solutions, with the ability to demo these solutions internally and externally
Identify strategic opportunities from Data Cloud Intelligence solutions and present actionable findings to client stakeholders during insight readouts.
Act as a primary point of contact for Data Cloud-related questions from client account teams, providing accurate and timely support.
Offer strategic recommendations during RFP responses, identifying creative applications of Zeta's identity, intelligence, and activation solutions to differentiate client proposals.
Train client account teams on how to leverage Data Cloud Intelligence solutions, enhancing client teams' ability to independently utilize platform features
Support day-to-day Data Cloud operational requests, ensuring smooth execution of client initiatives
Independently kick off and troubleshoot Data Cloud reports, ensuring timely and successful delivery to stakeholders.
Audit and maintain client accounts, verifying that all requested solutions are accurately loaded and active.
Capture client needs and feedback that align with the Zeta product roadmap, acting as a liaison between client teams and Zeta's Product team.
Advocate for client-driven enhancements, ensuring client needs are communicated clearly to influence future platform developments
Qualifications
Thrives in a challenging, fast-paced entrepreneurial environment with real-time impact on day-to-day business, championing a high agency mindset
Highly organized and detail-oriented, with proven ability to manage multiple projects and prioritize effectively under dynamic conditions
Analytical thinker, comfortable with quantitative analysis and data interpretation
Translates complex data findings into clear, concise, and compelling narratives tailored to various audiences
Creative problem-solver who can think outside the box to develop innovative solutions
Collaborative team player with strong independent working skills; self-motivated and dependable in driving initiatives forward
Proficient in Excel (VLookups, Pivot Tables, Logic-based queries, data cleaning & filtering)
Advanced in Microsoft PowerPoint for professional client-facing presentations
Preferred Qualifications
Expert in Microsoft PowerPoint
Proficient in Tableau
Working understanding of SQL and relational databases
BENEFITS & PERKS
Unlimited PTO
Excellent medical, dental, and vision coverage
Employee Equity
Employee Discounts, Virtual Wellness Classes, and Pet Insurance And more!!
SALARY RANGE
The salary range for this role is $70,000 - $75,000, depending on location and experience.
PEOPLE & CULTURE AT ZETA
Zeta considers applicants for employment without regard to, and does not discriminate on the basis of an individual's sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Zeta discriminate on the basis of sexual orientation, gender identity or expression.
We're committed to building a workplace culture of trust and belonging, so everyone feels invited to bring their whole selves to work. We provide a forum for employees to celebrate, support and advocate for one another. Learn more about our commitment to diversity, equity and inclusion here: ***************************************************
ZETA IN THE NEWS!
************************************************
#LI-DD1
#LI-REMOTE
$70k-75k yearly Auto-Apply 42d ago
Manager, Clinical Data Analytics
Agios Pharmaceuticals 4.5
Remote job
Manager, ClinicalData Analytics Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve.
We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate.
Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built.
To learn more, visit www.
agios.
com and follow Agios on LinkedIn and X.
Job Description:The Manager, ClinicalData Analytics will manage, contribute, and support the integration of different clinical systems data into clinicaldata warehouse/ data review / analytics platform to enhance efficiencies in collaboration with key stakeholders for cross-functional data review.
Design, develop and maintain data mappings, data rules, and data transformations to populate clinicaldata warehouse with source data to provide one data review reporting/analytics solution for the cross functional stakeholders.
Serve as a subject matter expert and provide expertise for study database development, reporting data mapping programming.
Provide expertise on problem-solving with clinicaldata, functionality and capabilities.
Provide input into assessment of new technologies, collaborates with cross-functional teams, IT and QA for implementation, validation and rollout as necessary.
Partner with IT and QA to test and implement system upgrades for elluminate system.
Support development of departmental SOPs and processes.
Provide application administration and technical support for tools such as elluminate, spotfire, SQL Server or other reporting tools.
Perform programming, testing, mapping, data feeds and documentation in accordance with programming standards and validation procedures using reporting tools such as elluminate Data Central, spotfire, SQL server or other reporting tools to support the study teams.
Program and generate data review tools such as patient profiles and targeted data listings in support of data review.
Work with clinical trial project teams and management to adhere to quality standards and project timelines.
Telecommuting available anywhere in the United States.
Job Requirements:Requires at least Bachelor's degree or foreign equivalent in Computer Science, Computer Information Technology, or a related field.
Must possess 5 years of progressive postbaccalaureate experience with all of the following: (a) pharmaceutical industry experience performing reporting and analytics programming and data warehouse management; (b) performing programming, testing, mapping, and creating data feeds and documentation using SQL Server; (c) working with clinicaldatabases; (d) creating data visualization using Spotfire (e) working with relational databases SQL Server, MySQL, and Oracle; (f) data reporting and programming in SQL and PL/QL; (g) loading eCFR data from electronic data capturing system and cleaning data; and (h) working with regulatory guidelines including GCP/ICH, FDA/EMA/CHMP, and 21 CFR Part 11.
Experience may be gained concurrently.
Telecommuting available anywhere in the United States.
What we will give you:Deliberate Development.
Your professional growth as one of our top priorities.
Flexibility.
We're all about individual needs.
We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity.
When you're at your best, we're at our best.
Premium benefits package.
We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
Competitive and equitable performance-based compensation.
This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
The current base salary range for this position is expected to be between $161,803 - $165,044 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Psychological safety.
We support an environment of fearlessness.
We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
Commitment to diversity.
We strive to foster a welcoming workplace where everyone can thrive.
We're continuously looking to improve the inclusivity of our workforce.
Commitment to community.
We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
#LI-DNI
$161.8k-165k yearly 1d ago
Remote Principal Clinical Data Manager
Jobgether
Remote job
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Data Manager. In this role, you will play a crucial part in managing clinical trial data processes, ensuring compliance with industry standards and protocols. Your expertise will drive the delivery of high-quality data and maintain relationships with stakeholders. This remote opportunity allows you to contribute to cutting-edge clinical research across various therapeutic areas while ensuring the effective oversight of data management operations and leading a team to success.Accountabilities
Act as the primary contact for data management communications and issue resolutions.
Perform hands-on data management tasks and review database specifications.
Resolve queries from data sources and provide assistance to stakeholders.
Plan and manage data processing activities for clinical projects.
Validate electronic data and lead quality check initiatives.
Conduct training on data management systems and processes.
Participate in project management meetings and ensure timely deliverables.
Develop and maintain Data Management Plans and Quality Review Plans.
Contribute to improving departmental processes and compliance with regulations.
Requirements
M.Sc. or B.Sc. in a related field.
Ten (10) years of experience in clinical trial data management.
In-depth understanding of clinical trial regulations and guidelines.
Leadership skills in managing clinicaldata operations.
Effective communication and presentation skills.
Ability to organize and manage multiple projects efficiently.
Knowledge of data management processes and quality delivery.
Benefits
Competitive salary range: $130,000 - $155,000.
Flexible work-from-home options.
Opportunity to work with leading global healthcare organizations.
Professional development and training opportunities.
Supportive work environment that promotes diversity and inclusivity.
Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.#LI-CL1
$130k-155k yearly Auto-Apply 4d ago
Senior Clinical Data Manager
Novotech
Remote job
About the Role
The core responsibility for this position is as a member of Novotech' s Data Management group. The Senior ClinicalData Manager's (SCDM's) role is to control all aspects of data management and to ensure compliance with Good ClinicalData Management Practices (GCDMP).
As an experienced CDM, the SCDM provides mentorship to junior staff and can also provide support to the project manager. Expectation of being a leader within the department by leading process improvements, new initiatives as well as training for junior colleagues
Responsibilities
Member of the project team reporting to the Project Manager for integrated projects, the Senior ClinicalData Manager is responsible for planning, conducting, and managing of all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements, and SOPs.
Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated.
May function as Project Manager for “stand-alone” data management projects.
Input into the preparation of RFPs in liaison with BD and the clinical team.
Liaison with the project team and client for preparing and maintaining Data Management Plans.
Responsible for all aspects of data management including:
Design and review of database structure, validation rules and consistency checks Operation of ClinicalData Management Systems
All data cleaning/validation tasks
Development of all key Data Management Documents
Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stake holders.
Liaison with external service providers on Data Management projects as appropriate
Assist in the development of protocols as required.
Supervision and training support for junior and contract Data Management staff as required.
Experience and Qualifications
Graduate in a clinical or life sciences related field. At least eight to ten years' experience in a similar role working in the research, pharmaceutical industry or a related field.
Salary Band - $110,000 - 145,000 Salary offered will be based on candidates experience level.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
$110k-145k yearly Auto-Apply 20d ago
Oncology Clinical Data Specialist III (Part Time)
Johns Hopkins Medicine 4.5
Remote job
PART TIME 100% Remote / Flexable work schedule The DataSpecialist reviews selection criteria, evaluation parameters, and analyzes diagnostic information to determine inclusion and exclusion of clinicaldata entry into database. This role will gather clinicaldata from various medical records, internal and external data sources, for the purpose of reporting to registry stakeholders. DataSpecialist will compile all required information, including but not limited to outcome and process measures, annual follow-up and ongoing vital status. This data is critical to operational reporting, quality and safety reporting and mandated regulatory reporting to federal and state health agencies. Data will also serve for purposes of patient care management, research, epidemiological studies, state, and national data submission. This role is responsible for supporting Johns Hopkins Hospital, Johns Hopkins Bayview, Johns Hopkins Howard County Medical Center, Suburban Hospital, Sibley Hospital and All Childrens' Hospital. This role reports to the Registry Manager.
Competencies:
Education:
Requires successful completion of:
a) Associate's degree from an accredited School OR
b) 2 years of related work experience
Bachelor's degree preferred.
Essential Functions:
* Abstract clinically relevant data from electronic medical records and report to registry or hospital databases
* Based on a thorough understanding of the registry products, may respond to all requests for information
* Clinical interpretation of data definitions in accordance with registry reporting standards
* Assists with internal and external audits
* Assists with report generation and communication pathways
* May assist with data submission process; quality assurance and control processes
* May assist with data mining for projects
* Complete annual requirements for maintenance of registry certification, if applicable
* Assist with regular communication of results and initiatives via scorecards, dashboards, newsletters, memos, emails, etc.
* Assists in collecting materials used to generate reports and presentations
* Performs other duties as assigned
Salary Range: Minimum 23.96/hour - Maximum 39.57/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.
We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.
Johns Hopkins Health System and its affiliates are drug-free workplace employers.
$54k-68k yearly est. 17d ago
Senior Clinical Data Manager
Eclinical Solutions 4.4
Remote job
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate ClinicalData Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.
You will make an impact:
As a Senior ClinicalData Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior ClinicalData Manager, you may delegate tasks/responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
Primary representative for eClinical Solutions and sponsor data management interaction
Responsible for monitoring and ensuring adherence to study timelines and deliverables
Accountable for the overall quality of data management activities and deliverables at the study or program level
Ensure efficiency and consistency for data management tasks across programs
Communicate with global study teams
Participate in client study kickoff and closeout/lessons learned meetings
Create materials for and present at Investigator Meetings
Develop content and deliver Sponsor CRA and/or site training
Delegate tasks, support and provide guidance to study data management team
Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text
Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications
Participate in Internal System Testing (IST) on the database/user roles/edit check specifications
Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting
Utilization of centralized data management platform including graphical patient profiles and operational analytics
Compile the sponsor UAT package
Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications
Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools
Oversee and/or perform data review for overall consistency and accuracy
Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinicaldatabase
Oversee and/or perform query processing/resolution
Provide ongoing data management reports and metrics
Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study
Define and develop specifications for database, programming and/or edit check changes as needed throughout the study
Track data management issues and ensure follow up to resolution
Identify data issues and/or data trends, communicate to the ClinicalData Management team and Sponsor, assist with development and implementation of action plan
Maintain data management study documentation
Perform steps pertaining to database freeze/lock and coordinate all related activities
Ongoing evaluation of process and participate in process improvement
Assist in the creation and review of SOPs, WIs, and training materials
Mentor junior level staff and peers on all associated tasks within a study
Participate in proposal defenses
Perform other duties as requested by management
Take the first step towards your dream career. Here is what we are looking for in this role.
Qualifications:
Bachelor's degree in Pharmaceutical/Biotechnology or higher in health-related field preferred
8+ years in ClinicalData Management experience preferred
Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology
Strong project management experience and project team leadership skills including work planning and work delegation
Experience with EDC and performing data management activities
Excellent verbal and written communication skills
Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
Experience with EDC and ClinicalData Management Systems
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ******************************************************
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
Pay Range
US Pay Ranges $100,000-$125,000 USD
$100k-125k yearly Auto-Apply 40d ago
Manager, Clinical Vendor Management
Apogee Therapeutics
Remote job
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary
The Manager, Clinical Vendor Management is a member of the Clinical Trial Excellence Vendor Strategy & Management team and is responsible for facilitating the identification, selection, and management of clinical study vendors and providing portfolio level issue trending, escalation and management. This role will act as a liaison between Apogee and external vendors while working to find cost savings and operational efficiencies and will help support and implement the strategic vision outlined by the Vendor Strategy & Management Lead. He/she will work with cross-functional members of the Apogee organization (Clinical, Finance, and Legal) to assess the best fit for Apogee's growing Phase 2 and 3 trial needs. This role will focus on initial MSA contract negotiations, rate cards, scope review and issue escalation associated with assigned vendors. This individual will participate in the standardization of Clinical Operation processes and will ensure sourcing objectives are aligned with corporate/operational goals.
Key Responsibilities
Collaborate with business partners to research and evaluate potential vendors based on their capabilities, pricing, and service level agreements
Build strong relationships with key vendors
Conduct ongoing assessment of vendor relationship performance through KPI review, vendor performance trend analysis, and administration/interpretation of stakeholder satisfaction surveys
Drive and improve existing systems and processes
Maintain knowledge of market trends for assigned key vendors
Lead and conduct high visibility and competitive negotiations
Support sourcing policies, contingency plans, and additional strategic initiatives established by the Vendor Strategy & Management Lead
Support Clinical Operations Vendor Sourcing and vendor governance related meetings
Hold vendors accountable to performance goals/agreements
Drive annual third-party vendor spend savings while improving processes and vendor relationships
Closely manage deliverable timelines and cross-functional input to keep reviews, decisions, and initiatives on track
Participate in the continuous improvement process for programs within purview
Lead/participate in vendor strategy and budget discussions
Collaborate on contracts review to verify compliance with MSA, discount structures, and performance requirements
Ideal Candidate
Knowledge of the drug development process in complex indications for large global programs
Strong understanding of contracting process and ability to negotiate and manage contractual arrangements.
Ability to prepare bids, requests for quotes, and proposals
Excellent communication skills with an ability to present to a variety of stakeholders and tailor messages accordingly
Proven ability to influence and make decisions in a matrixed environment
Comfortable leading candid conversations on vendor delivery and driving to resolution of performance challenges
Partnering with study teams and vendors to effectively manage conflicting viewpoints and challenging situations with minimal negative impact
Experience in problem solving capabilities; can see a problem from multiple angles and provide viable, innovative options for resolution
Demonstrated ability to effectively manage priorities to achieve goals and support unplanned work
Bachelor's degree in management, finance, or related field
5 years of relevant experience working in a pharmaceutical/biotech company or CRO
Excellent leadership skills and big-picture mentality
Ability to keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 20%
The anticipated salary range for candidates for this role will be $150,000 to $160,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
What We Offer
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Flexible PTO
Two, one-week company-wide shutdowns each year
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A
pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
To review our privacy policy, click here
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$150k-160k yearly Auto-Apply 60d+ ago
RN Clinical Data Analyst, Miami Neuroscience Admin, Day Shift
Baptisthlth
Remote job
RN ClinicalData Analyst, Miami Neuroscience Admin, Day Shift-155558Description Responsible for the abstraction, collection, outcome analysis, and dissemination of clinical information. Maintains and builds patient registry databases and manages data for assigned research studies and projects. Additionally, acts as a data reviewer and analyst to support the quality objectives of patient care services and participates in core quality data measurement and standards maintenance activities. Duties include designing forms for data collection, clinicaldata abstraction, data entry, processing data, maintaining record systems, data management, and producing project reports. Additionally, participates in multi-disciplinary teams and provides feedback on the processing and quality of data collected. Ensures compliance with all federal and local policies for the collection of clinicaldata.Qualifications Degrees:
Bachelors.
Licenses & Certifications: Registered Nurse.Collab Inst Training Init.
Additional Qualifications:
Bachelor Science Nursing - BSN. Experience in a healthcare setting, previous experience in a medical office, hospital, clinical research, or academic setting desired. Two years Neuro experience preferred. Experience with managing research data, performance improvement or other quality assurance activities preferred. Oral and written communication skills sufficient to interpret and apply policies and procedures for clarification/problem resolution. Computer skills proficient to operate online systems and complex software with advanced functionality. Expertise in MS Office products and using electronic medical record systems to access patient data.
Minimum Required Experience:
3 YearsJob CorporatePrimary Location RemoteOrganization CorporateSchedule Full-time Job Posting Dec 31, 2025, 5:00:00 AMUnposting Date Ongoing Pay Grade R21EOE, including disability/vets
$63k-92k yearly est. Auto-Apply 7d ago
Research Data & Report Analyst - Clinical Trials Reporting
Aa067
Remote job
Research Data & Report Analyst - Clinical Trials Reporting - (10032546) Description Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses.
Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
A Research Data and Report Analyst position is available to support the NCI Clinical Trials Reporting Program at the National Medical Center of City of Hope.
You will collaborate with all levels of staff to support end-user and institutional reporting needs across clinical research applications and Enterprise Data Warehouse.
You will develop, implement, and maintain the process for entering summary level accrual information in OnCore and manage the data integrity across multiple clinical research systems.
Additionally, you will be responsible for the submission of all NCI supported interventional trial accruals to the National Cancer Institute Clinical Trials Reporting Program (NCI CTRP) and ClinicalTrials.
gov website.
You will also participate user requirement analysis, process development, clinical research system testing, policy and procedure development, training and support to system users as summarized below.
Your Duties and Responsibilities will include:Clinical Research System Data Quality· In partnership with the senior leadership team, develop and implement policies and procedures to support the quality of data in the OnCore CTMS· Assist in the quality control of required clinical research FDA reporting for COH studies· Responsible for leading quality control of data between OnCore and the external research systems (CTRP and ClinicalTrials.
gov) for COH investigator initiated studies· Monitoring Quality Assurance (QA) of data within the OnCore system and will perform routine QA checks and analysis via various OnCore reporting tools.
· Closely monitor data integrity of the OnCore system and overall functionality· May assist with writing training manuals· May write training manuals, FAQs, newsletters or other similar documents for dissemination to end users· Assists OnCore administrator with other appropriate tasks as needed Submission to NCI CTRP and NIH ClinicalTrials.
gov· Develop, maintain, and be responsible for the submission process of NCI supported interventional clinical trial accruals s to NCI CTRP· Develop, maintain, and be responsible for the submission process of investigator initiated interventional clinical trials for posting on the NIH ClinicalTrials.
gov website as per federal regulations· Update submission SOPs to reflect the latest changes in submission requirements and regulations for NCI CTRP and ClinicalTrials.
gov website· Collaborate with the Data Quality Manager of Analytics & Decision Support to develop reports and notifications to support NCI CTRP accrual reporting management and NIH ClinicalTrials.
gov submission workflows.
· Maintain access provisioning for NCI CTRP and NIH ClinicalTrials.
gov websites for City of Hope staff· Provide subject matter expertise regarding NCI CTRP accrual reporting and 42 CFR 11 (Final Rule) and NIH ClinicalTrials.
gov regulations and requirements, including training of staff for timely and accurate submissions System and Business Analysis· In collaboration with the City of Hope Senior leadership teams and stakeholders, provides system configuration, design, and testing for Epic and OnCore as requested.
· Responsible for development of sub-systems within projects· Designs, develops, and documents programs assigned by project manager· Assists in establishing system testing requirements and in conducting overall system testing· Coordinates implementation of system and coordinates testing of system components.
· Provides support to end-users for various applications.
· Responds to calls from users requiring information on system performance and use, defining enhancements, and resolving problems· Attends meetings with users to discuss related systems.
Provides follow-up in relation to progress of requests and resolution of problems Qualifications Your qualifications should include:· Bachelors degree in life sciences, information technology, business administration or related fields.
Bachelors degree or higher is preferred.
· 3 years of experience in systems and database management· Experience with sponsored research management / research operations software systems· CCRP or ACRP certificate is preferred but not required· Prior experience within grant management systems is preferred· Experience within sponsored research, academic or research environment is preferred.
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, please CLICK HERE.
Primary Location: US-Nationwide-USA-RemoteJob: Clinical ResearchWork Force Type: RemoteShift: DaysJob Posting: Nov 5, 2025Minimum Hourly Rate ($): 35.
682500Maximum Hourly Rate ($): 55.
307600
$63k-92k yearly est. Auto-Apply 11h ago
Remote Clinical Data Code, Oncology
Globalchannelmanagement
Remote job
Remote ClinicalData Code, Oncology needs 2+ years of experience in clinicaldata coding, preferably in oncology trials.
ClinicalData Code, Oncology requires:
Part time
20 hours weekly
Bachelors degree in Life Sciences, Health Information Management, or related field.
Strong understanding of clinical trial data standards and regulatory requirements.
Excellent attention to detail and ability to manage multiple coding tasks in a fast-paced environment.
Results-driven, take initiative and ownership to accomplish work. Knowledge of ICH, Good Clinical Practice and FDA regulations.
Proficiency with Rave Coder and familiarity with MedDRA and WHO Drug dictionaries. Effective time management and organization skills.
Strong communication skills for cross-functional collaboration with CRAs, CDMs, and medical reviewers.
Experience with coding in global, multi-site oncology studies. Good interpersonal, written and verbal communication skills.
ClinicalData Code, Oncology duties:
Perform ongoing medical and medication coding using Rave Coder in accordance with MedDRA and WHO Drug dictionaries.
Review and resolve auto-coded and manually coded terms, ensuring alignment with SMPA coding conventions and internal SOPs
Collaborate with ClinicalData Managers to clarify ambiguous or unclear verbatim terms and issue coding queries when necessary
Maintain coding listings and ensure all terms are coded and approved prior to database lock
Support coding-related documentation and contribute to the development and maintenance of coding guidelines and SOPs
Participate in system validation, user acceptance testing, and updates related to coding modules and dictionary integrations.
Review and resolve complex or ambiguous verbatim terms, escalating to medical reviewers or clinical teams as needed.
Monitor coding metrics and quality indicators, proactively identifying trends and areas for improvement.
Ensure adherence to Data Management standards
$79k-109k yearly est. 60d+ ago
Manager Global Clinical Data Management
Namsa 4.2
Remote job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Manage a group working with various clients and projects on clinical research data management and database development and validation in the medical device industry. Both paper-entry and electronic data capture systems are used in these activities.
• Manage relationships with vendors providing database software to NAMSA Clinical.
• Allocates staff for projects - hourly and project-based.
• Hourly on-site projects:
o Is one of the principal spokespersons and the company's primary interface with the customer
o Negotiates technical, schedule and quality issues with the customer and utilizes Executive Management support as needed.
o Reviews cost and technical progress as compared to contractual requirements on a continual basis; takes appropriate actions to resolve issues and achieve client satisfaction.
• Participates in the NAMSA Clinical Operations Management Meetings.
• Reviews, edits and approves customer and hourly project subcontractor invoices and negotiates issues.
• Negotiates cost related issues with the customer (with the support of Senior Management).
• Writes and manages project estimates and proposals as needed.
• Works collaboratively with cross-functional teams to increase company efficiencies.
• Identifies and guides process improvement projects.
• Maintains departmental vendor relationships.
• Updates Departmental Data Management SOPs, Work Instructions, and Guidelines.
• Prepares for and participates in client and regulatory agency audits; maintains audit readiness within the Department.
• Participates in meetings with prospective clients.
• Identifies opportunities to bring in new projects/clients.
• Negotiates with vendors.
• Offers opportunities to clients for expansion of MRO services to be provided by NAMSA.
• Initiates and guides ongoing MRO projects.
Qualifications & Technical Competencies:
• Bachelor's degree required; advanced degree is a plus, with a minimum of 3+ years of prior management experience of data management group preferred, and
• Prior work experience in database management role preferred.
• Fluency in English and local language, if different, required.
• Demonstrates computer skills including Access, Word, Excel and Power Point.
• Experience with data management activities and database development/validation process
• Knowledge of data collection requirements in medical device industry
• Familiarity with electronic data capture (EDC) systems
• Knowledge of standards, regulations and technical resources to meet customer expectations and regulatory requirements.
Working Conditions:
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds (12 kgs). Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
• Ability and flexibility to manage OUS NAMSA Associates and clients, and adapt to different time zones.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
$88k-119k yearly est. Auto-Apply 7d ago
Registered Nurse - Clinical Documentation Integrity Data Analyst
University of Washington 4.4
Remote job
University of Washington Medical Center has an outstanding opportunity for a Registered Nurse - Clinical Documentation Integrity Data Analyst to join our team.
WORK SCHEDULE
Full-Time
Mondays-Fridays
Remote position
POSITION HIGHLIGHTS
The Clinical Documentation Integrity (CDI) Data Analyst is responsible for conducting on-going analyses of clinical documentation key performance indicator data and metrics while providing extensive collaboration with physicians, nursing staff, other patient caregivers, and medical records coding staff to improve quality and completeness of documentation of care provided and coded. Compile metrics and reports and serve as the expert on CDI Software and Executive Data.
PRIMARY JOB RESPONSIBILITIES
Create and analyze reporting of CDI metrics related to various quality programs and organizational initiatives as required.
Report accuracy data to the CDI Lead and Managers regularly. Collaborate with the CDI Managers, Lead and SLR's to identify patterns, trends, and variations in clinical documentation and code assignments.
Present data to providers and other health professionals related to documentation and the CDI program.
Participate in multi-disciplinary enterprise quality and process improvement teams
Perform other duties as assigned.
REQUIREMENTS
Bachelor's degree in Nursing (minimum) with current WA or compact RN Licensure; additional Data Science degree preferred.
2 + years prior nursing experience in an acute inpatient hospital setting with in-depth knowledge of medical and surgical care.
Minimum 3 years of CDI experience; CCDS and/or CDIP preferred.
In-depth Education and/or experience in clinical analytics reporting and analysis. Demonstrated ability to create reports, organize and display results and analyze and identify trends over time.
Super user for 3M, PDM, Solventum Data and EPIC slicer/dicer.
Proficiency in Vizient and Elixhauser methodology and proficiency navigating the Vizient database.
ABOUT UW MEDICAL CENTER-MONTLAKE
UW Medical Center is an acute care academic medical center located in Seattle with two campuses: Montlake and Northwest. As the No. 1 hospital in Seattle and Washington State since 2012 (U.S. News & World Report) and nationally ranked in seven specialties, UW Medical Center prides itself on compassionate patient care as well as its pioneering medical advances.
The UW Medical Center-Montlake campus is located on the edge of the beautiful UW campus which includes many amenities available to our staff as well as very convenient public transit options including the Sound Transit's light rail station across the street.
Excellence. Exploration. Education.
ABOUT UW MEDICINE - WHERE YOUR IMPACT GOES FURTHER
UW Medicine is Washington's only health system that includes a top-rated medical school and an internationally recognized research center. UW Medicine's mission is to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty care to the people of the region, and preparing tomorrow's physicians, scientists and other health professionals.
All across UW Medicine, our employees collaborate to perform the highest quality work with integrity and compassion and to create a respectful, welcoming environment where every patient, family, student and colleague is valued and honored. Nearly 29,000 healthcare professionals, researchers, and educators work in the UW Medicine family of organizations that includes: Harborview Medical Center, UW Medical Center - Montlake, UW Medical Center - Northwest, Valley Medical Center, UW Medicine Primary Care, UW Physicians, UW School of Medicine, and Airlift Northwest.
Become part of our team. Join our mission to make life healthier for everyone in our community.
Compensation, Benefits and Position Details
Pay Range Minimum:
$126,000.00 annual
Pay Range Maximum:
$168,888.00 annual
Other Compensation:
-
Benefits:
For information about benefits for this position, visit ******************************************************
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a regular position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
Not Applicable
About the UW
Working at the University of Washington provides a unique opportunity to change lives - on our campuses, in our state and around the world.
UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.
Our Commitment
The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81.
To request disability accommodation in the application process, contact the Disability Services Office at ************ or **********.
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.
$126k-168.9k yearly 4d ago
Change Management Specialist (REMOTE)
Koniag Government Services 3.9
Remote job
Koniag Tech Infrastructure Solutions, LLC a Koniag Government Services company, is seeking a Change Management Specialist to support KTIS and our government customer. This is a remote position. We offer competitive compensation and an extraordinary benefits package including health, dental and vision insurance, 401K with company matching, flexible spending accounts, paid holidays, three weeks paid time off, and more.
**Essential Functions, Responsibilities & Duties may include, but are not limited to:**
+ Develop and implement comprehensive change management strategy for implementation
+ Conduct stakeholder analysis and develop targeted communication strategies
+ Create change readiness assessments and identify potential resistance areas
+ Design and execute communication plans to support system rollout
+ Develop change impact assessments for affected business processes
+ Create and maintain change management documentation and version control processes
+ Support organizational transformation from legacy systems
+ Collaborate with training team to ensure change management aspects are incorporated into training materials
+ Support continuous improvement initiatives post-implementation
+ Coordinate with leadership to ensure organizational alignment
+ Manage change-related risks and develop mitigation strategies
**Required Qualifications:**
+ Bachelor's degree in Organizational Development, Change Management, Business Administration, or related field
+ Minimum 3 years of experience in change management for IT implementations
+ Experience with federal government organizational change initiatives
+ Strong understanding of change management methodologies
+ Excellent communication and stakeholder engagement skills
+ Experience with process improvement and organizational transformation
**Preferred Qualifications:**
+ Experience with Agile transformation initiatives
+ Knowledge of federal acquisition processes
+ Experience with large-scale system implementations
**Our Equal Employment Opportunity Policy**
The company is an equal opportunity employer. The company shall not discriminate against any employee or applicant because of race, color, religion, creed, ethnicity, sex, sexual orientation, gender or gender identity (except where gender is a bona fide occupational qualification), national origin or ancestry, age, disability, citizenship, military/veteran status, marital status, genetic information or any other characteristic protected by applicable federal, state, or local law. We are committed to equal employment opportunity in all decisions related to employment, promotion, wages, benefits, and all other privileges, terms, and conditions of employment.
The company is dedicated to seeking all qualified applicants. If you require an accommodation to navigate or apply for a position on our website, please get in touch with Heaven Wood via e-mail at accommodations@koniag-gs.com or by calling ************ to request accommodations.
_Koniag Government Services (KGS) is an Alaska Native Owned corporation supporting the values and traditions of our native communities through an agile employee and corporate culture that delivers Enterprise Solutions, Professional Services and Operational Management to Federal Government Agencies. As a wholly owned subsidiary of Koniag, we apply our proven commercial solutions to a deep knowledge of Defense and Civilian missions to provide forward leaning technical, professional, and operational solutions. KGS enables successful mission outcomes for our customers through solution-oriented business partnerships and a commitment to exceptional service delivery. We ensure long-term success with a continuous improvement approach while balancing the collective interests of our customers, employees, and native communities. For more information, please visit_ _****************** _._
**_Equal Opportunity Employer/Veterans/Disabled. Shareholder Preference in accordance with Public Law 88-352_**
**Job Details**
**Job Family** **Consulting Services**
**Job Function** **Change Management Consultant**
**Pay Type** **Salary**
$61k-100k yearly est. 39d ago
Coastal Management Specialist
Consolidated Safety Services
Remote job
CSS-Inc. may have multiple openings for Coastal Management Specialists to support NOAA's Office for Coastal Management (OCM). The successful candidates will work closely with state or territory partners and organizations to support the implementation of the National Coastal Zone Management Program and the National Estuarine Research Reserve Program, as authorized under the Coastal Zone Management Act (CZMA). Some position will also support the Coral Reef Management Program.
All positions are contingent upon contract award to CSS.
Locations vary, but typically allow for fully remote work within a defined geographic jurisdiction.
Specific responsibilities and tasks will include:
* Work with partners to understand and support the implementation of their coastal management programs, including review and oversight of their cooperative agreements with NOAA.
* Serve as liaison between NOAA OCM and state and jurisdiction partners in the specified region.
* Work with OCM federal staff, and state and local agencies, to address strategic priorities and achieve programmatic outcomes.
* Engage regularly with partners, both virtually and in-person, to provide technical and management assistance to implement programmatic priorities and cooperative agreements and ensure effective and efficient operations through performance evaluation and reporting.
* Contribute information on programmatic efforts to external and internal communication mechanisms; engage with other local, state, and regional stakeholders; and support partnership program connections to relevant regional entities.
* Support implementation of the reauthorized Coral Reef Conservation Act, including the management of block grants and cooperative agreements, and support for other grant programs
* Work with OCM leadership, including the Coastal Communities and Ecosystems Programs, Coral Program, and OCM Regional Lead(s), to maintain and strengthen long-term relationships in the region and leverage NOAA assets to address priority challenges
* Some travel will be required for national-level and regional meetings, site visits, and workshops; as well as occasional local travel.
Qualifications:
* Bachelor's or Master's degree in Environmental Policy, Marine Policy, or a related field.
* 3-6+ years of relevant professional experience.
* Documented experience in environmental planning, policy, technical, and regulatory support for the Federal Government preferred.
* Documented knowledge of/experience with coastal zone management issues, the Coastal Zone Management Act, and the Coral Reef Conservation Act.· Region-specific experience strongly preferred.
* Demonstrated experience with stakeholder outreach and engagement, especially relating to environmental policy issues.
* Training or demonstrated experience in facilitation strongly preferred.
* The successful candidate will be organized, detail-oriented, manage time to achieve project objectives to meet deadlines, and work both independently and collaboratively as part of a team.
* Ability to pass a National Agency Check and fingerprinting background check and maintain it through the duration of employment.
At CSS, we are committed to fostering an inclusive and merit-based workplace. We provide equal employment opportunities to all individuals, ensuring that hiring and employment decisions are based on qualifications, skills, and performance. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
$51k-90k yearly est. 34d ago
Remote Data Management Specialist
Bayscapes
Remote job
Position Description Bayscapes Inc. is looking for a reliable and detail-driven Remote Data Management Specialist to support our data organization and reporting operations from a remote location. In this role, you will maintain accurate records, ensure data integrity, and assist in preparing data-driven reports that support internal decision-making processes.
Key Responsibilities:
Accurately enter, update, and maintain data across systems
Review and audit data for errors, inconsistencies, and outdated information
Prepare routine and ad hoc reports for internal use
Collaborate remotely with cross-functional teams to ensure smooth data workflows
Support data integration and system updates as needed
Qualifications:
Previous experience in data management, data entry, or related field
Strong proficiency in Excel, Google Sheets, and cloud-based data tools
Excellent organizational skills and attention to detail
Ability to manage time effectively while working independently
Strong communication skills and a reliable internet connection Type: Full-time Pay: $26.00 to $30.00 per HOUR