Clinical research associate jobs in Santa Rosa, CA - 114 jobs

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Duration: 12 Months+ Contract ( possibility of extension) JOB DESCRIPTION: Top 3 qualifications: • Previous clinical research experience • Ability to prioritize and strong critical thinking skills • Attention to detail and strong communication skills Responsibilities: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Assist in preparation of study materials and/or training. Interface with, and assure training of investigators, site staff, and client clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review ). May arrange conference calls, staff meetings and training events. Assist data management group with review of clinical data/information and oversight of data correction. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. Must be willing to assist with other duties as needed such as filing and document tracking. Qualifications: Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. 3-5 years of experience Education required: 4 year degree Qualifications Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. 3-5 years of experience Additional Information Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do have referral bonus, if you refer any of your friends or colleague who are looking out for the same job. Thanks, Warm Regards, Nisha Integrated Resources, Inc. IT REHAB CLINICAL NURSING Inc. 5 0 0 0 - 2007, 2008, 2009, 2010, 2011, 2012 ,2013 and 2014 (8th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70 Direct: (732)-429-1649 Tel: (732) 549 2030 x 230 Fax: (732) 549 5549

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor Creates and implements subject enrollment strategies for assigned investigative sites Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Clinical Research Specialist 5 months with a possibility to extend Medtronic - Santa Rosa, CA Duties: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Assist in preparation of study materials and/or training. Interface with, and assure training of investigators, site staff, and Medtronic clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review). May arrange conference calls, staff meetings and training events. Assist data management group with review of clinical data/information and oversight of data correction. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. Must be willing to assist with other duties as needed such as filing and document tracking. Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. Qualifications Top 3 qualifications: Previous clinical research experience Ability to prioritize and strong critical thinking skills Attention to detail and strong communication skills Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 619-727-5167 ASAP! I want to know more about your preferences. If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!

Role OverviewThe Clinical Trial Research Scientist evaluates clinical study protocols, trial designs, endpoints, statistical plans, and study results. This role emphasizes methodological rigor, documentation clarity, and accurate interpretation of safety and efficacy outcomes. What You'll Do- Review clinical trial protocols and identify methodological strengths or gaps - Analyze endpoints, inclusion/exclusion criteria, and study controls - Interpret trial results and summarize safety and efficacy findings - Validate statistical analysis plans for completeness and accuracy - Identify operational or scientific risks in trial execution - Support recurring evaluations of clinical documentation and study outputs What You BringMust-Have:- Experience in clinical research, biostatistics, or pharmaceutical science - Strong understanding of trial methodology and regulatory standards - Ability to interpret trial data and communicate findings clearly Nice-to-Have:- Experience with Phase I-IV trials or specific therapeutic areas

Zipongo enables Eating Well Made Simple. We provide Foodsmart--FoodSmart population nutrition analytics integrated with FoodsMart ad-free buying with options ranging from Amazon Fresh & Sun Basket to GrubHub & Compass Cafes, Telenutrition, and Foodscripts health plan food subsidy disease reversal programs to hundreds of employers and health plans, including 5 of the 7 largest health plans in the US. Job Description We are looking for an outstanding Clinical Research Scientist with strong human subjects research and statistics experience (nutritional epidemiology preferred) to evaluate and improve our Foodsmart, Telenutrition and Foodscripts services, as we grow from nearly 1 million enrolled users today to are goal of 10 million users in the coming years. To start, this position is responsible for coordinating new research studies as a Principal Investigator or in collaboration with our Chief Medical Officer, Scientific Advisors or other partner academic PIs, conducting statistical analyses, reviewing literature, drafting manuscripts in collaboration with internal and external co-authors, and assisting with day-to-day activities of the research team to support cross-functional collaboration with clinical education, product, and commercial teams. Responsibilities Coordinate operations and logistics for clinical trials as key study personnel under the direction of the Primary Investigator. Oversight of future clinical trials is a possibility with appropriate experience/expertise. Collaborate with PIs to conduct statistical analyses supporting all Zipongo internal and external clinical research projects including the Zipongo Nutrition Registry, randomized controlled trials and cost-effectiveness analyses. Perform literature reviews to enable evidence-based decision making and written assets. Assist with drafting, editing, and submission of manuscripts for peer review in collaboration with co-authors. Build productive collaborations with co-workers in data science, clinical care and education, graphic design, product, and commercial teams. Develop systematic and semi-automated processes to expedite evaluation of multiple variables via multiple sub-studies. 90 Day Plan As you begin your first 3 months with Zipongo, we you will work to accomplish the following: Coordinate operations and logistics to launch a new research study while working closely with the study PI. Perform data analyses of patient nutrition and health outcomes that prove or improve patient outcomes and health plan costs while gaining fluency with our internal data tools. Lead a retrospective analysis that leads to a strong publication submission and drives hypotheses for future study. Establish strong working relationships with Zipongo team members in research and beyond. Qualifications MS or MPH in nutrition, physiology, public health, psychology, biomedical science, epidemiology, biostatistics, or a related field. 2+ years of statistics experience with SPSS, python, R, or similar tool. (Experience with SQL is a plus.) Experience in human subjects research including study coordination and progress reporting. Strong experience and attention to detail in data collection, management, and reporting. Ability to iterate on processes to increase efficiency and effectiveness in these tasks. Impeccable integrity for research ethics and data analysis/presentation. Exceptional written and verbal communication skills across a variety of audiences (professional, medical/scientific, patients) and with patient-centered tone and personality. Ability to work at start-up speed and possess intellectual curiosity with the desire to improve health outcomes for patients. Bonus requirements: PhD in nutrition, physiology, public health, psychology, biomedical science, epidemiology, biostatistics, or a related field. 4+ years statistics experience with SPSS, python, R, or similar tool. Experience with SQL. Expertise in epidemiology, biostatistics, and use of observational, real world data for deriving insights and developing hypotheses. Minimum of 5 peer-reviewed publications including first author or senior author manuscripts and demonstration of excellent scientific writing. Leadership of research collaborations involving co-authors from multiple fields. Experience with nutrition studies as well as cardiometabolic disease, diabetes, cardiology, lipidology, oncology, autoimmune disease, behavioral medicine, telemedicine, digital and mobile health. Additional Information Values drive Zipongo's culture, so you'll do well if your own values are rooted in being: Measurable: You leverage data and results to iterate on problems rapidly, and do not rely on politics or tradition drive projects Impactful: You let your focus on mission drive you in having a positive impact and not get caught up in small daily challenges; you focus on the biggest rocks over the pebbles and the sand. Collaborative: You are humble, transparent, open to transparent feedback and kind to your colleagues as you seek out their collaboration and share learnings Accountable: You are empowered, and take accountability for your work and projects the team counts on you for Creative: You bring urgency and creativity to overcome challenges with speed and tenacity.

Hi, Hope you are doing well!!! My name is Shyam and I'm a recruiter at Artech Information Systems, a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position. If you believe you're qualified for this position and are currently in the job market or interested in making a change, please give me a call as soon as possible at **************. You may also respond to me via email with a copy of your updated resume and your best contact number and timings for further discussion. Job Description The Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk. The Senior Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. Additional Information Shyam Sheriel Associate Recruiter - Staffing Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973. 507 . 7514 | Fax: ************

+ Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study + Ensures alignment of regional deliverables with overall study goals **Essential Functions of the job:** **Regional Leadership** + Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study + Leads external vendors involved in study delivery on a regional level + Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional study team members **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these + Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study plans as required + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems and tools is entered and up to date + Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports + Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region + Manages the trial data collection process for the region, drives data entry and query resolution + As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads + Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point in time throughout the study life cycle + Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented + Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate + Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies + Contributes to development, optimization and review of work instructions and SOPs as required **Budget and Resources** + Works with the sourcing team to select and manage regional study vendors + Manages regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides performance feedback on team members as required + Might mentor junior team members **Computer Skills:** MS Office, Project Planning Applications **Other Qualifications:** + 4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead in clinicial functions + Experience as CRA is preferred **Travel:** Travel might be required as per business need **Education Required:** Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred _*exceptions might be made for candidates with relevant clinical operations experience_ **Competencies:** **Ethics -** Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures. **Planning/Organizing** **-** Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction. **Communication** **-** Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information. **Teamwork -** Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others. **Adaptability -** Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. **Technical Skills** **-** Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others. **Dependability** **-** Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. **Quality** **-** Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. **Analytical** **-** Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. **Problem Solving** **-** Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. **Project Management -** Communicates changes and progress; Completes projects on time and within budget. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. Elevate your career by leading groundbreaking clinical trials as a Clinical Trial Lead at a forward-thinking biopharmaceutical organization. This pivotal role offers the opportunity to oversee and direct complex trials, collaborate with cross-functional teams, and partner with CROs and vendors to drive scientific innovation and ensure excellence in clinical development. Join a dynamic team committed to advancing therapies that make a real difference in patients' lives. Key Responsibilities: Lead and support end-to-end clinical trial activities, managing budgets, timelines, and resources with a focus on quality and operational efficiency. Develop and oversee clinical operational plans aligned with study objectives, ensuring regulatory compliance (ICH/GCP), SOP adherence, and inspection readiness. Oversee vendor selection, management, and performance, including CRO oversight, site feasibility assessments, and regulatory submissions. Collaborate on clinical documentation such as protocols, investigator brochures, and study reports, ensuring clarity and compliance. Represent Clinical Operations in cross-functional project teams, external stakeholder meetings, and regulatory inspections. Monitor study progress, communicate status, costs, and issues to senior management to facilitate timely decision-making. Lead quality initiatives, SOP development, and continuous process improvements to optimize clinical trial execution. Manage and mentor Clinical Operations staff, fostering development, performance, and a cohesive team environment. Build and maintain strong relationships with investigators, site staff, key opinion leaders, and external partners.

About Us: Timberlyne Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs. Timberlyne's lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers. Position Summary: Timberlyne is seeking a Clinical Trial Associate (CTA) to join the Clinical Operations team. The Clinical Trial Associate will participate in planning and assisting in managing the conduct of clinical trials in accordance with company policies and procedures and applicable regulations. This position is a key member of the Clinical Operations team, responsible for providing administrative and operational support throughout the duration of a clinical study. Essential Responsibilities: Supports the Clinical Operations team under the supervision of the Clinical Program Manager. May contact clinical trial sites, vendors, CROs, and partners as needed. Performs administrative tasks to support clinical project teams. Maintains the Trial Master File (TMF). Prepares meeting agendas, meeting minutes, and tracking logs. Tracks clinical trial progress, including enrollment tracking, status update reports, and other reports as needed for assigned clinical trials. Submits applicable documents to the Trial Master File (TMF). Follows applicable Standard Operation Procedures (SOPs) Assists with the creation and maintenance of documentation for assigned clinical trials. Documents may include, but are not limited to presentations, pharmacy manuals, regulatory binders, lab manuals, and training materials. Partners with external vendors for accurate distribution of all clinical trial-related materials to clinical trial sites or clinical team members. Responsible for scheduling internal meetings and meetings with external collaborators and generating timely meeting minutes. Assists with creation and distribution of study-level communication to stakeholders. Supports the study team by proactively identifying, resolving, and/or escalating issues to assigned staff. Under general supervision collects, processes and tracks investigator sites and regulatory documents required by the FDA, and other regulatory authorities. Coordinates, processes, and tracks shipments (i.e., supplies, study-related materials, etc.) Serves as a point of contact for clinical supplies, document collection and preparation for close-out. Prepares and maintains documents and files such as clinical study files, regulatory binders, and operations manuals for clinical sites (i.e., informed consent form, protocol and investigators brochure). Assists with the quality review of documentation e.g., ICFs, regulatory green light packages. Capable of handling additional tasks with little supervision. Skills and Experience: S. or B.A. in biological sciences, advanced degree preferred, with 2+ years of relevant industry experience. Ability to travel as required. Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. Ability to establish and maintain effective working relationships with coworkers, managers, vendors, and clients. Excellent written and verbal communication skills. Significant attention to detail, time management and organizational skills with the ability to multi-task and prioritize. Ability to deal with time demands, incomplete information or unexpected events. Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities. How To Apply: Please send your resume to ************************* All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.

Perceive Biotherapeutics is an exciting clinical-stage company (lead program in Phase 2), focused on improving human health by developing breakthrough neuroprotective therapeutics in ophthalmology that use novel approaches to treat highly prevalent, blinding diseases that currently have no good therapeutic alternatives. Perceive brings together an experienced, worldclass team of leaders, scientists and drug developers. Our unique approach is a first-in-class and best-in-class gene therapy that will significantly impact patients' lives. Our team is mission driven, expert, agile and pragmatic. We are looking for a talented and experienced individual to join our growing Clinical Operations team and contribute to the company's long-term goals and success. The successful candidate will be diversely experienced, thoughtful, collaborative, highly motivated & productive, and possess the desire to learn, improve processes, and support key clinical stakeholders during our Ph 1 and Ph 2 trials with an emphasis towards quality, efficiency and operational best practices. Responsibilities Context and Job Duties/Responsibilities: This role is intended to ensure end-to-end clinical management, including trial set-up, enrollment, execution and cross-functional coordination with multiple clinical trial sites and vendors in global Ph 1 and Ph 2 trials, per established timelines. The CPM will be responsible for site, CRO and trial vendor management to ensure timely and high-quality clinical trial conduct, maintaining strong relationships between service providers and clinical trial sites, and for keeping management apprised of clinical progress against established milestones. This individual will help to set the standards for clinical operations performance and build the wider culture of accountability, collaboration and continuous improvement. A successful candidate in this role will quickly determine and address needs along these lines: Manage defined aspects of clinical trials to ensure trials are completed on time and in compliance with Code of Federal Regulations (CFR), ICH/GCP guidelines and company SOPs. Plan, coordinate and manage activities within various phases of clinical studies (i.e. study planning, site qualification and selection, study start-up, enrollment, monitoring, data review and cleaning, closeout, etc.). Contribute in development of essential study documents and develop, review/approve study specific operational documents, tools and tracker Provide Vendor Management and Oversight (participate in selection, qualification, contracting of clinical vendors, coordinate and/or lead vendor set-up and management activities) Build and maintain great working relationships with KOLs and PIs and extended site staff at clinical sites and participate in site interactions and management from identification through closeout. Drive cross-functional collaboration with internal stakeholders to support timely and aligned trial execution. Contribute to departmental process improvement initiatives and support the growth and mentorship of junior team members, where applicable. Travel: Up to 20% travel may be requested for site engagement and internal meetings. These may include multi-day international trips. Position is remote Pacific Time zone work hours is strongly preferred. Qualifications Education, Experience, Capabilities and Knowledge: A successful candidate for this role is an expert in all aspects of pharmaceutical clinical research and the requirements of the clinical operations function. The successful candidate also thoroughly understands early, mid and late-stage trial performance, forecasting, staffing, and business operations. Qualifications include: Bachelor of Science degree required with a focus in a biomedical or related clinical field strongly preferred; advanced degree also preferred. 3+ years of experience in clinical operations, with at least 2 years of direct clinical trial management experience at a sponsor or CRO required. At least 5 years of experience in the clinical research / pharmaceutical / biotech / medical device industries. Experience with retina/ophthalmology and gene therapy strongly preferred. Experience in a small, innovative company environment preferred. Previous on-site monitoring experience is preferred. Proven ability to drive timelines, quality, and compliance across multiple vendors and Trainings and Skills Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), and medical terminology. Demonstrated ability to lead clinical projects to timelines and on budget, including detailed tracking, troubleshooting, and effective escalation with excellent planning and organizational skills. Demonstrated success in working with outside organizations/groups/vendors/CROs. Strong project management skills. Excellent communication, negotiation, and stakeholder management skills. Strong critical thinking, organizational, and problem-solving abilities.Demonstrated track record of success working in remote or hybrid work environments. High personal integrity, strong work ethic, accountability, and a solutions-oriented Demonstrated leadership and team management skills. Demonstrated business acumen with strong understanding of sponsor business Location This is a remote position. Targeted annual pay band is $165,000-195,000 with some flexibility commensurate with experience. Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. Please note that Perceive Bio will only collect personal information using a legitimate company email domain and will never offer payment or any financial transaction over text or email. Always verify that emails or other communications are directly from perceivebio.com. #LI-DNI

We're looking for a Senior Experience Researcher to help make looking for health insurance work better. eHealth gives people and small businesses all the tools they need to make providing health insurance for themselves and others simpler, more pleasant, and more productive. The Mission It's complex looking for healthcare. It's not always just about making information consumable, it's can also be about helping customers deal with existential fears. So making that experience better is the perfect challenge for any researcher who is looking to contribute to people's lives and meet real needs. If you've been conducting research for digital natives for your whole career, then be ready to continue helping them, but you will also be working for those on the other side of the digital divide - the poor and the elderly. We are helping them get plans too - plans that include Medicare related plans and family health plans. Whatever product you are working on, you will always find that the customers who are using them are not abstract at all. They may even be your friends and family. Designing Product Our researchers do more than help create better online experiences. We are looking for researchers who are both tactical AND strategic. We work with a product team that wants us to help define product requirements. So, we take the insights we've gained about our customers - how they shop for healthcare, and their needs - and use them to help shape product strategy and invent new products. In many ways, our researchers are closer than anyone to our customer. We need your voice early on in product ideation. That said, you will also have to see both sides of the products. Not only will you see products from the customer viewpoint, you'll learn about how they are shaped by insurance agencies and the government. If you want to be in the middle of one of the most important conversations in America, then work here. If you also have a passion for hard core transactional online experiences, this is an interesting place to hone your craft. For example we need to learn about where the customer is health-wise in order to recommend some plans. We can easily default to how insurance providers ask questions and run customers through a massive decision tree. But people may see the same information differently. It's part of their story. It's what they did last year. It's what has happened to them and where they are headed. So could it be better to help them tell the story of their health first and learn from that - make that our starting point rather than an insurers form? We need researchers partnering with product managers and designers to help sort out these kinds of questions to make real advances. It's a fun and absorbing challenge. Research You will also do your own dirty work by producing a full range of research deliverables that may include screeners, interview scripts, and presentations on accessibility. Your activities may include moderating, conducting primary research, and actively engaging in the process of product design to help keep knowledge about the customer alive and applied. The Team You will be working as part of the Design Team. We have years of experience on the team and have pulled people together from a range of leading design teams such as Amazon's Mobile Innovation and Augmented Reality Team, Disney, Hallmark Labs, Macy's Integrated Retail Labs and Walgreen's retail design team. We have your back and are all bringing something to the table. We provide a highly customer-centric, team-oriented environment in our offices located in San Francisco, California. We also have a secondary location for the team within eHealth's offices in Santa Clara and may consider blending time in the office with working from home. We have a culture that: • demands authentic empathy for our customers • is excited by the business mission of the company • runs on collaboration with other disciplines • requires you to come up with ideas on your own • takes a collectivist approach to creating design processes, tools and methodologies • has strong and opinionated leadership pushing the department to evolve • supports everyone in having long and passionate careers • recognizes the need to have a balanced life that includes family, friends, health and wellness • demands authenticity • seeks to humanize technology • looks for connections into the larger Bay Area design and research community What You Will Be Doing • Contribute to products that may include individual health plans, family plans, plans for small businesses and a range of Medicare related plans • Work with designers to pitch product ideas to cross discipline groups and cowrite product specs • Proactively plan and execute customer research throughout the design and development lifecycle, from early strategic direction through post-release validation • Share customer insights with the broader organization to increase customer intelligence, including posters, theater, blog posts, and workshops • Coach and mentor others on the design team • Work with design leadership to inform and improve design processes • Work with cross discipline leadership to get your insights into our products and help get products out. About eHealth Founded in 1997, eHealth is the nation's first and leading private health insurance marketplace. Millions of individuals, families and small businesses use our top-rated tools to compare and purchase health insurance from leading insurers like Aetna, Humana, Kaiser Permanente and Wellpoint. In addition to health, dental and vision insurance products, eHealth also provides powerful online and pharmacy-based tools to help Medicare beneficiaries navigate Medicare health insurance options, choose the right plan and enroll in select plans online Qualifications Basic Qualifications: • 5+ years of professional research experience • Strong track record of using qualitative and quantitative methods to develop actionable insight that impact product strategy and development • Up-to-date research methods and the agility to work in different ways depending on your context • Ability to collaborate with a wide set of stakeholders including designers, product managers, and engineers • Ability to execute in a fast-paced environment • Excellent communication skills, with the ability to distill complex ideas to their essence Preferred Qualifications: • Knowledge of the healthcare and insurance industry • Experience working with insurance related products and services • Bachelor's degree in cognitive or experimental psychology, human computer interaction, human factors, or related field; MS/PhD preferred • Experience researching multichannel experiences • Mobile experience • Experience with agile software development Additional Information All your information will be kept confidential according to EEO guidelines.

Alljoined is a biotech research startup using EEG to decode human thought. We are seeking study participants in San Francisco. You will wear a non-invasive EEG cap while seated at a computer, view images and videos, and answer simple questions. The device measures brain responses and does not cause discomfort. Requirements Age 18-55 Comfortable sitting for extended periods Fluent in English Able to attend 5 total sessions No dreadlocks, braids, wigs, or hairstyles incompatible with an EEG headset Location Inner Richmond, San Francisco, CA Session Length Approximately 2.5 hours (budget for 3) Compensation $20 per hour

Study Participants Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world. Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills. The role We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects. Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter. What you'll bring A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable) A willingness to take our screening to assess your suitability for our participant pool Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time A reliable and fast internet connection and access to a computer A willingness to self-declare your earnings, as our participants are self-employed A Paypal account to receive payment from our clients What you'll be doing in the role Completing paid research studies such as answering surveys, participating in experiments, and providing written responses Providing feedback, judgements, and opinions in structured research tasks Contributing to high-quality research outcomes by responding thoughtfully and accurately Key study types Surveys and Questionnaires Behavioural Experiments User Research and Product Feedback Educational and Academic Studies Interviews and Open-Ended Responses Quality Checks and Attention Tasks Why Prolific is a great platform to join as a Participant Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home. We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines. We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity. Links to more information on Prolific Website Youtube Privacy Statement By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.

Grow Your Career in ABA Therapy! ABA Clinical Coordinator Schedule: Full-Time Setting: Hybrid - In-Home & In-Center Make a real difference in the lives of children with autism! As an ABA Clinical Coordinator, you'll provide leadership, support, and clinical oversight to ensure high-quality ABA therapy that transforms lives every day. Join a supportive organization that values teamwork, professional growth, and meaningful impact. Pay Incentives Starting Now! We're excited to recognize your leadership and flexibility with competitive pay and new incentives: $30-$35/hour based on experience Bonus: Effective November 16thWeekend sessions (Saturday & Sunday):➤ +$10.00 per billable hour on top of your current hourly rate Effective December 1st Monday through Friday sessions starting at 6:00 PM or later: ➤ +$5.00 per billable hour on top of your current hourly rate Earn more while supporting your team and helping families thrive! What You'll Do Oversee and implement individualized ABA treatment programs Supervise, train, and mentor Behavior Technicians Collaborate with families and caregivers to promote meaningful progress Monitor treatment fidelity and ensure clinical quality standards Participate in team meetings and ongoing case reviews What You Need Master's degree (or currently enrolled) in ABA, Psychology, or a related field 1-2+ years of ABA or clinical supervision experience Valid California Driver's License and proof of auto insurance RBT certification preferred Bilingual (Spanish-English) preferred Current CPR/First Aid, fingerprint clearance, and required immunizations (Rubella, Rubeola, Mumps, Varicella, Hepatitis B/Tdap - declination acceptable, TB clearance within 3 months) What We Offer Supervision hours toward BCBA certification Ongoing training and professional development Company-provided laptop and phone Supportive, collaborative, and growth-oriented environment Apply today and grow your career while changing lives - including your own. Once you apply, please check your email or phone - our team will contact you to schedule a quick phone interview!

Job Description Exciting Opportunity: Clinical Coordinator We are seeking a compassionate and detail-oriented Clinical Coordinator to support our team of field clinicians in delivering exceptional patient care. This role offers a dynamic work environment where you will assist in coordinating patient services, manage essential medical documentation, and ensure smooth communication between patients, families, and healthcare providers. Key Responsibilities: Work closely with field clinicians to ensure the highest standard of patient care is maintained. Assist the clinical team by managing, clarifying, and tracking medical orders, as well as ensuring all relevant documentation is in place. Communicate directly with patients, families, and physicians regarding care plans. Input orders, float visits, and ensure all supporting documentation is uploaded to the electronic medical records (EMR) system. Play an active role in the orientation and training of new team members. Manage medical supplies, ensuring stock levels are maintained, and organize the medical supply room in compliance with company and OSHA standards. Conduct audits and other assigned tasks to ensure compliance and quality standards are met. Perform additional duties as required to support the clinical team and ensure efficient operations. Schedule: Day shift Monday to Friday What You Bring: Current California RN or LVN License. Strong communication skills, both verbal and written, with the ability to connect with patients, families, and team members. Proficiency with technology, including Apple products provided by the company. Exceptional organizational and time management skills, with the ability to handle multiple tasks and work independently. Friendly and professional demeanor, comfortable handling high call volumes and delivering excellent customer service. Knowledge of medical terminology and a strong understanding of home health care operations. Why You'll Love This Role: You'll be joining a team dedicated to making a real impact on patient care in a supportive and collaborative environment. As a key player in our operations, you will help ensure that our patients receive the best care possible while also contributing to the success of the clinical team. If you're passionate about healthcare and enjoy a fast-paced, fulfilling role, this is the perfect opportunity for you!

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Clinical Research Specialist 5 months with a possibility to extend Medtronic - Santa Rosa, CA Duties: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Assist in preparation of study materials and/or training. Interface with, and assure training of investigators, site staff, and Medtronic clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review). May arrange conference calls, staff meetings and training events. Assist data management group with review of clinical data/information and oversight of data correction. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. Must be willing to assist with other duties as needed such as filing and document tracking. Must have ability to prioritize and critical thinking skills and previous clinical research experience. Must have strong written, oral, and interpersonal communication skills and high attention to detail and accuracy. Qualifications Top 3 qualifications: Previous clinical research experience Ability to prioritize and strong critical thinking skills Attention to detail and strong communication skills Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 619-727-5167 ASAP! I want to know more about your preferences. If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!

Hi, Hope you are doing well!!! My name is Shyam and I'm a recruiter at Artech Information Systems, a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position. If you believe you're qualified for this position and are currently in the job market or interested in making a change, please give me a call as soon as possible at **************. You may also respond to me via email with a copy of your updated resume and your best contact number and timings for further discussion. Job Description The Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk. The Senior Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff. Additional Information Shyam Sheriel Associate Recruiter - Staffing Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************

+ Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an indication or across a program as required + Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study + Ensures alignment of regional deliverables with overall study goals + Contributes to the development of regional tools and leads the development of work instructions and SOPs as required **Essential Functions of the job:** **Regional Leadership** + Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study + Leads external vendors involved in study delivery on a regional level + Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional operations meetings with all regional study team members + Displays therapeutic area knowledge and expertise **Timelines, Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines + Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these + Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study plans as required + Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems and tools is entered and up to date + Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports + Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region + Manages the trial data collection process for the region, drives data entry and query resolution + As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads + Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point in time throughout the study life cycle + Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented + Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate + Collaborates with CST members and othercolleagues to ensure cross-team, site learnings, and best practices are shared + Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies + Leads the development, optimization and review of work instructions and SOPs as required **Budget and Resources** + Works with the sourcing team to select and manage regional study vendors + Manages regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides performance feedback on team members as required + Mentors junior team members and might take on line management responsibilities as required **Computer Skills:** MS Office, Project Planning Applications **Other Qualifications:** + 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead in clinical functions + Experience as CRA is preferred **Travel:** Travel might be required as per business need **Education Required:** Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred _*exceptions might be made for candidates with relevant clinical operations experience_ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients. The Clinical Trial Manager (CTM) independently manages all components of high-complexity clinical trials and leads multidisciplinary, cross-functional Study Management Teams. This role is accountable for ensuring clinical trial activities and deliverables are completed on time, within budget, and in compliance with GCP/ICH requirements and SOPs. The position supports the company's research and development efforts to deliver high-value therapeutics addressing unmet medical needs. Key Responsibilities: Oversee and manage all aspects of clinical trials in accordance with SOPs, ICH/GCP regulations, and study-specific manuals and procedures. Independently lead Study Management Teams, including cross-functional partners, CROs, and third-party vendors. Develop and maintain effective relationships with key internal and external study stakeholders. Own key study quality metrics, including eligibility and primary endpoint data. Lead the identification, evaluation, and selection of CROs and third-party vendors in compliance with company SOPs. Manage CRO and vendor performance, including expectations, training, timelines, deliverables, and issue resolution. Manage clinical study budgets, ensuring adherence to scope and appropriate handling of out-of-scope activities. Identify study risks in collaboration with the Study Management Team and develop mitigation plans, escalating to senior management as needed. Author or contribute to clinical protocols, informed consent forms, study manuals, CRFs, and other clinical trial documentation. Ensure clinical data review is conducted per study data review plans and deliver a final clean dataset at database lock. Coordinate study supply and packaging requirements. Manage expert consultants supporting study activities and identify program or resource gaps with proposed solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements to enhance efficiency and consistency within Clinical Operations. Lead or participate in functional initiatives and special projects as assigned. Mentor and support the development of junior clinical operations staff, as applicable.