eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data 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 Clinical Data 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 Clinical Data 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 clinical database
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 Clinical Data 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 Clinical Data 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 Clinical Data 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 48d ago
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Senior Billing and Revenue Analyst
Eclinical Solutions 4.4
Remote Eclinical Solutions job
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data 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.
You will make an impact:
The Senior Revenue and Billing Analyst is responsible for overseeing and optimizing billing and revenue operations within NetSuite, ensuring invoices and revenue recognition align with customer contracts, company policies, and applicable accounting standards. This role partners closely with Project Management, Operations, and Finance to support accurate, timely, compliant, and scalable financial reporting.
This position is expected to leverage NetSuite automation, reporting, and approved AI-enabled tools to improve efficiency, accuracy, and insight across billing and revenue processes while maintaining strong accounting judgment and internal controls.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
Develop, maintain, and optimize billing and revenue recognition rules for client services and licensing contracts in accordance with ASC 606, configured and maintained within NetSuite.
Prepare, review, and issue customer invoices across multiple billing models, including time and materials, fixed fee, unit-based, milestone-based, percentage of completion, and subscription-based arrangements.
Perform detailed contract reviews to ensure billing terms, performance obligations, and revenue schedules are accurately reflected in NetSuite.
Reconcile contract financials, including amounts billed to date, deferred and recognized revenue, remaining contract balances, and phase-level tracking as required.
Support month-end close activities, contract closeouts, third-party pass-through cost reconciliation, and internal and external audits.
Leverage NetSuite saved searches, SuiteAnalytics, and reporting tools to analyze billing and revenue data, identify trends, variances, and potential issues.
Utilize approved AI-enabled productivity and analytics tools (e.g., NetSuite analytics enhancements, Microsoft Copilot) to support reconciliations, variance analysis, forecasting, and reporting, validating all outputs for accuracy and compliance.
Identify opportunities to streamline or automate billing and revenue workflows through NetSuite configuration, system enhancements, and AI-supported process improvements.
Collaborate with Accounts Receivable, Project Management, Operations, Finance Systems, and other stakeholders to resolve billing inquiries, discrepancies, and process gaps.
Other duties as assigned
Take the first step towards your dream career. Here is what we are looking for in this role.
Qualifications:
Bachelor's Degree in Accounting, Finance, or related field or equivalent experience
5+ years of experience in billing, revenue, and contract accounting in a professional services and/or SaaS environment preferred
Strong knowledge of revenue recognition principles under ASC 606.
Advanced proficiency in NetSuite ERP, including billing, revenue recognition, saved searches, and reporting; experience with NetSuite SuiteProjectsPro (formerly OpenAir) preferred.
Advanced proficiency in Microsoft Excel; experience using analytics, automation, or AI-enabled tools in a finance or accounting environment preferred.
Highly detail-oriented with strong analytical, organizational, and communication skills.
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 $75,000-$120,000 USD
$75k-120k yearly Auto-Apply 7d ago
Medical Screener
Biolife Plasma Services 4.0
Attleboro, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Attleboro
U.S. Starting Hourly Wage:
$19.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - AttleboroWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt 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.
$19 hourly Auto-Apply 1d ago
Global Immunology Cell Therapy Commercial Lead
Astrazeneca 4.6
Boston, MA job
A leading biopharmaceutical company is seeking a Global Commercial Director for Immunology Cell Therapy based in Boston. In this role, you will develop and implement commercial strategies and lead initiatives for launching new therapies in the market. Ideal candidates will have over 10 years of experience in pharmaceutical development and a strong understanding of commercial strategies. This position offers a salary range of $229,303 to $343,955 annually, along with various benefits, including health coverage and retirement plans.
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$229.3k-344k yearly 4d ago
Remote MSL: Osteoporosis Expert (Senior)
Upsher-Smith 4.7
Remote or Waltham, MA job
A biopharmaceutical company is seeking a Medical Science Liaison/Senior Medical Science Liaison based in the Dallas/Fort Worth metro area. This role involves developing relationships with healthcare leaders to improve health outcomes in osteoporosis. The ideal candidate will have a doctorate and experience in the sector. Key responsibilities include scientific communication, collaboration with stakeholders, and supporting research initiatives. The compensation range is competitive, reflecting experience and qualifications. This position requires up to 70% travel and offers a flexible remote work environment.
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$93k-147k yearly est. 21h ago
Global Safety Director: Risk Strategy & Leadership
Astrazeneca GmbH 4.6
Boston, MA job
A leading pharmaceutical company is seeking a Director, Safety Scientist in Boston. This role involves leading risk management for key projects, mentoring safety scientists, and ensuring compliance with regulatory standards. The ideal candidate has advanced degrees and extensive experience in drug safety. This position offers a competitive salary range of $175,000 to $263,000 along with various benefits and incentives.
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$175k-263k yearly 21h ago
Global Brand Leader, Oral PCSK9i
Astrazeneca 4.6
Boston, MA job
A top pharmaceutical company in Boston is seeking a Global Commercial Head for the oral PCSK9i asset. This pivotal role involves developing and executing a comprehensive global marketing strategy, leading brand planning, and leveraging customer insights to inform product strategies. The ideal candidate will have over 15 years of experience in pharmaceutical commercialization, with a strong background in cardiovascular, renal, and metabolic functions. Exceptional leadership and collaboration skills, alongside a BA/BS in related fields, are essential for this role.
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$109k-142k yearly est. 4d ago
Global Pain Market Research Lead
Vertex Pharmaceuticals (San Diego) LLC 4.6
Boston, MA job
A leading biotechnology company is seeking an Associate Director, Global Pain Market Research to join its Boston team. In this role, you will oversee commercial insights supporting the Global Commercial Strategy for pain management. Key responsibilities include designing primary market research and developing the annual situation analysis. Candidates should have a Bachelor's degree and 8+ years of relevant experience in market research and bio-pharma marketing. Flexible work options are available.
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$102k-132k yearly est. 1d ago
Inside Sales Representative-Eastern Time Zone
Vetoquinol USA 4.0
Remote or Boston, MA job
The Inside Sales Representative is responsible for establishing and maintaining profitable relationships with customers on behalf of the company by taking personal and complete responsibility for each customer contact and by ensuring that all customer requirements are completely met. This position is 100% remote/virtual,
preferably based in the region to which the ISR is assigned.
Essential Functions
Sales and Marketing
Consult with current and potential customers in an assigned geographic area using phone, email, texts, videoconferencing, and other platforms to convert new business, maintain current customers, and grow market share.
Communicate daily with Territory Managers, Regional Manager, Marketing, and other company organizations and external partners as required.
Form long-standing customer relationships with assigned accounts.
Develop and implement sales plans to meet business goals.
Travel occasionally as needed for training, sales meetings, conferences, etc.
Utilize Vetoquinol's Sales Excellence program to engage with customers.
Customer Service
Assist customers in a timely manner.
Manage orders taken by phone, email, or other methods; ensure accurate entry into the Customer Relationship Management (CRM) system and communicate information to distribution partners.
Organize workflow to meet customer and company deadlines.
Present and discuss the products and services of the company in a way that conveys an image of quality, integrity, and superior understanding of customer needs.
Manage inbound and outbound phone calls professionally and efficiently, using good communication skills.
Attend to customer questions, complaints, and concerns immediately, and facilitate satisfactory resolution.
General/Administrative
Document all customer interactions with detailed notes in the CRM system.
Support the company vision and mission, and demonstrate the corporate core values in all professional activities.
Comply with all OSHA safety requirements, work rules, and regulations.
Compile and maintain all required records, documents, etc.
Follow systems and procedures outlined in company manuals.
Communicate out-of-office plans to manager and teammates to ensure uninterrupted customer coverage.
All other duties as requested by management.
Qualifications
Formal Education and Certification
Bachelor's Degree or 3+ years of inside sales experience preferred.
Knowledge and Experience
Inside sales experience highly preferred.
Experience in the animal health industry highly preferred.
Personal Attributes
Exceptional written, verbal, and interpersonal communication skills.
Ability to work under pressure and with shifting priorities.
Team player willing to participate in meetings and other team activities.
Ability to manage time efficiently and to multi-task.
Vetoquinol USA is an equal opportunity employer. We are committed to providing a workplace that is free from discrimination of any kind and that promotes diversity, inclusion, and fairness. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. Join us and be a part of a great place to work!
A leading biotechnology company in Boston is seeking an experienced Senior Director, Finance Technology to drive innovation across Financial Systems, focusing on Tax, Treasury, and Accounting. The ideal candidate will have over 12 years of experience in financial systems leadership, strong stakeholder engagement skills, and a passion for technology. This role offers competitive compensation and hybrid work options.
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$71k-96k yearly est. 3d ago
Senior Manager, Order to Cash
Vertex Pharmaceuticals 4.6
Remote or Boston, MA job
**Job Description****General Summary:**Vertex is seeking an experienced Order to Cash professional to join our Controllership organization as a senior manager within the Global Revenue Accounting team. The Controllership organization is integral in delivering Vertex's mission of creating transformative medicines for people with serious and life-threatening diseases. You will be working as part of a dynamic and diverse organization alongside outstanding people who are forward-thinking, collaborative and recognized leaders in their areas.The position is a key role within Global Revenue Accounting, and we are seeking an experienced and strategic Senior Manager within Order to Cash “O2C” to manage our credit control function, drive cash flow optimization, manage internal controls and implement solutions that strengthen financial performance. The successful candidate will combine hands-on credit control expertise with strategic insight, leading a team of two to maximize collections, minimize risk, and support business growth.Central to this role is fostering exceptional working relationships across the Controllership function, Global Supply Chain, our third-party logistics providers, and regional finance teams. The individual will also be well organised, comfortable presenting and influencing senior stakeholders and able to manage competing deadlines.This role is highly visible across the international organisation and with our global head office in Boston and offers excellent opportunities for personal development and continuous improvement. As Vertex continues to grow, and expand geographically, the successful candidate will have many opportunities to shape processes and drive lasting change.**Key Duties and Responsibilities:*** Work with global finance, revenue accounting, trade ops, supply chain and market access teams to ensure we remain at the forefront of any changes to our ways of working* Implement and enforce credit policies and procedures that mitigate risk while supporting customer relationships* Present credit & collections updates to Senior Directors and Departmental Heads* Build strong relationships with our external service providers, internal stakeholders and business partners* Represent the team at Global Credit Committee meetings, interacting with the Global Finance and Chief Accounting Officer's leadership team* Develop and execute credit strategies that optimize cash flow, reduce Days Sales Outstanding (DSO), and minimize bad debt* Protect Vertex's credit risk with consideration for securitisation initiatives.* Design process solutions in support of key business decisions and new product/country launches* Drive improvements in our monthly Dashboard reporting* Drive transformation initiatives (system/process/policy)* Participate in global projects representing the needs and interests of the O2C and wider Revenue Accounting team* Analyse the performance of external service providers against KPIs* Ensure our ongoing compliance to all O2C related SOX controls**Knowledge and Skills:*** Ability to work collaboratively with external service providers, to ensure the highest standards of execution are maintained and the interests of Vertex and its patient remain forefront* Strong stakeholder management skills, able to quickly establish credibility and build effective, collaborative, working relationships at all levels* Excellent communication and interpersonal skills necessary for leading cross functional projects and presenting to senior management (including accounting, finance and commercial management)* Ability to partner with other functional areas to develop, improve and monitor compliance with policies and procedures including taking a leadership role on certain initiatives* Strong financial analysis and reporting skills* Strong knowledge of credit control, risk management, and regulatory compliance* Strategic thinker with ability to provide solutions to cash flow and credit challenges* People management skills, with experience motivating and developing teams* Solution-focused with experience in improving processes and systems* Ability to pivot based on demand and prioritization**Education and Experience:*** Bachelor's Degree in Accounting or Business administration, or equivalent business experience* Strong credit control/accounts receivable experience, in a managerial or leadership role* Experience in large, complex, or multinational organizations preferred* Experience in pharmaceutical industry preferred#LI-SG1#LI-Hybrid**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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$131k-172k yearly est. 4d ago
Automation Mechanical Design Engineer for Cell Therapy
Vertex Pharmaceuticals 4.6
Boston, MA job
A leading biotechnology firm in Boston seeks a Senior Mechanical & Automation Engineer. This role involves developing and automating manufacturing solutions for innovative therapies. Candidates should have extensive experience in automation development, mechanical design, and a strong understanding of cGxP principles. This is a five-day-a-week role requiring onsite presence for three days weekly. Compensation ranges from $75 to $90 per hour, with eligibility for overtime pay.
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A pioneering neuroscience company based in Boston, MA is seeking a firmware developer to create embedded solutions for advanced brain stimulation devices. The ideal candidate will have a strong background in C programming, experience with BLE protocols, and a passion for building innovative healthcare technologies. The role offers comprehensive benefits, including health insurance and stock options.
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$109k-140k yearly est. 21h ago
Finance Systems & Reporting Excellence Director
Vertex Pharmaceuticals 4.6
Boston, MA job
A leading biotechnology company is seeking a Director, Global Process Excellence to enhance finance systems and processes integral to scaling operations. This role requires extensive finance experience, capability in project management, and leading cross-functional improvements. The position offers a hybrid work model and competitive salary range of $180,800 - $271,100, along with generous benefits and annual bonus eligibility.
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$180.8k-271.1k yearly 1d ago
Senior O2C & Credit Control Leader - Cash Flow Champion
Vertex Pharmaceuticals 4.6
Boston, MA job
A global biotechnology company is seeking a Senior Manager for their Order to Cash function to drive cash flow optimization and manage credit control. This role requires excellent stakeholder management and financial analysis skills. The successful candidate will work closely with various teams, present updates to senior leadership, and have opportunities for personal development in a hybrid-eligible environment. Experience in pharmaceutical or large organizations is preferred.
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$113k-150k yearly est. 4d ago
Director, Statistical Programming
Eclinical Solutions 4.4
Eclinical Solutions job in Mansfield, MA
The Director Statistical Programming provides input regarding planning, management, and logistics for statistical programming services. The Director Statistical Programming assists in developing the strategic vision for all statistical programming activities. The Director Statistical Programming will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. The Director Statistical Programming will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. The Director Statistical Programming will work as needed assuring that all client work has met or exceeded client expectations.
KEY TASKS & RESPONSIBILITIES
Provide input regarding planning, management, and logistics for statistical programming services
Assist in developing the strategic vision of the department which can be integrated into the overall corporate vision
Support the development of policies, procedures, and standards
Participate in resource management and allocation activities
Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
Provide mentoring and QC of statistical programmer's outputs; define analysis data specifications. If required, validate the statistical models used for programming
Act as a study Lead - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
Develop, review, and finalize the statistical analysis plan
Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
Develop randomization schedule, specifications, and guidelines
Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
Wherever applicable, develop, validate, and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses
Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
Champion the evolution of statistical programming through automation and advanced analytics using elluminate
Lead internal initiatives focused on standards governance, coding conventions, validation frameworks, and reusable assets
Evaluate emerging technologies (R, Python, automation tools, AI-driven methods) to expand capabilities
Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures
Other duties as assigned
CANDIDATE'S PROFILE
Education & Experience
Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field and/or equivalent work experience preferred
10+ years' experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
5+ years in a leadership role managing teams, managers, or large-scale programming operations preferred
Excellent knowledge of English
SAS certification is preferred
Professional Skills
Strong experience with clinical study design development, analysis, and sample size determination
Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
Knowledge of CDISC related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures
Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
Ability to balance conflicting priorities
Excellent verbal and written communication skills
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Excellent team player
Technical Skills
Experience of statistical procedures and latest developments and trends in statistical analysis methodologies. Knowledge of working in different therapeutic areas and related indications
Strong knowledge of statistical programming and ability to use various software systems like SAS, SPSS, and S-Plus. Ability to do statistical computing using R is a plus
Knowledge and ability to use various tools like J-Review, and Spotfire for effective data queries and analysis
Strong experience in various SAS software modules including SAS/STAT, and SAS/Graph
Thorough understanding of developing macros and SAS system
Thorough knowledge of design of experiments and statistical modeling. Experience of developing statistical designs for phase-I, phase-II, and phase-III clinical protocols
Experience of pooled data analysis and in designing specifications for integrating data from multiple trials
Knowledge of Analysis dataset model for development of analysis and programming specifications is a plus. Ability to develop ADAM models based on trial data
Thorough knowledge of analysis of various standard and non-standard safety domains. Knowledge of PK data modeling is a plus
Strong experience in efficacy reporting with regards to development of analysis sets and missing values
Proficiency in Microsoft Office Applications
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 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. 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 $148,000-$185,000 USD
$148k-185k yearly Auto-Apply 6d ago
Strategic Kidney Policy & Alliances Director
Vertex Pharmaceuticals (San Diego) LLC 4.6
Boston, MA job
A global biotechnology company is seeking a Policy & Alliance Development Director to build policy initiatives and strategic alliances focusing on kidney disease. The role involves developing reimbursement strategies and managing partnerships with patient organizations. Ideal candidates will have extensive experience in public policy, government affairs, and a Bachelor's degree. A hybrid work model is available, with competitive compensation between $204,600 and $307,000 annually.
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$204.6k-307k yearly 21h ago
Clinical Data Governance Lead, Portfolio Development
CSL Plasma Inc. 4.6
Waltham, MA job
A biotherapeutics leader in Waltham, MA is seeking experienced clinical operations professionals with 12+ years in clinical development. The role involves defining and maintaining clinical standards, collaborating across teams, and ensuring compliance with regulatory requirements. Candidates should have a strong background in clinical trials and excellent communication skills. Join a dedicated team focused on innovative therapies and patient care, where you can make a significant impact.
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$110k-155k yearly est. 21h ago
Global Marketing Director - Pove
Vertex Pharmaceuticals 4.6
Remote or Boston, MA job
**Job Description****General Summary:**Povetacicept is a pipeline in a molecule with a potential to transform treatment outcomes for patients. The Director, Global Marketing of Povetacicept is accountable for key indications understanding the market landscape and Vertex's position within the market, actively contributing to defining the strategy and performance goals of the portfolio and tracking performance against those goals.**Key Duties and Responsibilities:*** Develops the indication strategy for povetacicept for key indications, and oversees creation of brand strategies and lifecycle activities including launch planning and prioritization* Oversees development and implementation of strategic and tactical plans working across functions for a unified indication plan* Provides input into forecasting assumptions, both short term and long term* Generates and consolidates key insights across HCPs and patient stakeholders (through market research, ad boards, etc.)* Leads the development of strong partnerships with cross-functional team to support business goals including R&D and regional teams**Knowledge and Skills:*** Experience defining the strategy for a brand or portfolio of products with multiple indications/pipeline in a product* Ability to oversee generation of insights, and apply those insights to business problems/opportunities* Analytical mindset, with demonstrated ability to develop strategy, make strategic recommendations, monitor performance, understand ROI and allocate resources* Exceptional working knowledge of market forecasts and relationship of business drivers to revenue* Experience in pharmaceutical marketing. In-market and /or global marketing experience required. Neurology experience preferred.**Education and Experience:*** Bachelor's degree in marketing, business, or scientific degree* Typically requires 12 years of experience or the equivalent combination of education and experience**Pay Range:**$195,200 - $292,800**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. **Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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$195.2k-292.8k yearly 3d ago
Manager of Statistical Programming
Eclinical Solutions 4.4
Remote Eclinical Solutions job
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data 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.
OVERVIEW
The Manager, Statistical Programming is operationally responsible to ensure the direction, planning and execution of the work of the statistical programming team. The Manager, Statistical Programming provides project leadership and programming support for clinical studies. The Manager, Statistical Programming provides guidance in implementing and executing the programming and project standards plus provide hands-on expertise in programming SDTM and ADaM datasets to support various analyses and TLG Programming.
KEY TASKS & RESPONSIBILITIES
Determine resourcing needs per project load, deadline requirements and resource utilization
Create or review and approve programming plans at study and project level
Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plans, SAPs, etc.)
Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician
Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials
Assist Biostatisticians by suggesting algorithms to address novel analysis requests
Develop analysis datasets for trial level reporting and integrated safety and efficacy activities
Program and QC data listings, summaries and Graphs as defined in SAP
Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for all phases of clinical trial reporting
Create submission-ready SDTM and ADaM datasets following standard industry processes
Performs peer review of all SAS Programmers' deliverables
Serve as Subject Matter Expert for Statistical deliverables and lead task forces to develop complex, technical solutions for projects or business needs
Collaborate with the project team and other Professional Services Managers to ensure the deliverables are completed on time with high quality
Develops and maintains good working relationships with internal cross functional teams and Clients
Develops, revises, and maintains Standard Operating Procedures and Work Instructions. Assists in the training of Standard Operating Procedures and Work Instructions
Maintain all project documentation as required by SOP and Processes
Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
Champion the evolution of statistical programming through automation and advanced analytics using elluminate .
Lead internal initiatives focused on standards governance, coding conventions, validation frameworks, and reusable assets
May serve as Lead Statistical Programmer on projects when needed
Other duties as assigned
CANDIDATE'S PROFILE
Education & Experience
Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field and/or equivalent work experience preferred
8+ years' experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
2+ years of leadership, supervisory, or technical lead experience preferred
Excellent knowledge of English
Professional Skills
Strong experience in preparations for NDA filings
Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
Knowledge of CDISC related data models like SDTM, and ADAM
Experience of working on multiple clinical protocols at the same time
Excellent verbal and written communication skills
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Excellent team player
Technical Skills
Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures
Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must
Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate
Strong experience in SAS programming in various phases of clinical trial
Experience in pooled data analysis and programming
Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values
Experience in working with relational databases and performance tuning of SAS programming
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 $136,000-$170,000 USD
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eClinical Solutions may also be known as or be related to Eclinical Solutions, Eclinical Solutions LLC, eClinical Solutions and eClinical Solutions LLC.