This full-time position is responsible for ensuring the integrity, quality, and compliance of clinical trials conducted at Astera Cancer Care.
Job Description:.
The Clinical Trial Manager drives database lock readiness, oversees CROs and vendors, and ensures high-quality data and documentation that support regulatory submissions. The environment is that of a growing, fast-paced biotech organization focused on addressing unmet medical needs, offering high visibility with senior leadership and significant influence over pivotal Phase 3 trial outcomes.
Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Title: Clinical Research Administrative Assistant Location: Secaucus, NJ Reports To: Senior Vice President.
p>How You Will Add Value:
li>Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Partner cross-functionally with Clinical, Regulatory, Quality, Supply Chain, Biospecimen Operations, Legal, Procurement, and external vendors to support successful study execution and delivery of study milestones and clinical documents. Serve as the primary Clinical Operations lead and key point of contact for cross-functional study teams, investigators, CROs, vendors, and clinical sites.
li>Partner cross-functionally with Clinical, Regulatory, Quality, Supply Chain, Biospecimen Operations, Legal, Procurement, and external vendors to support successful study execution and delivery of study milestones and clinical documents.
p>To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.
Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Atlantic Health scored four "A" grades by The Leapfrog Group in its Fall 2025 Hospital Safety Grades, performance measures reflecting errors, accidents, injuries and injections, as well as systems hospitals have in place to prevent harm. The SPA I oversees the quality review and accuracy of Clinical Trial Agreements and Budgets and is responsible for tracking reports and perspective for refinement of operational activity in the Atlantic Health Clinical Research & Innovation Institute.
Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies.
p>The position combines strong digital and AI domains with function-level business and transformation leadership, requiring the ability to produce decision-grade insights for CSO leadership, translate complex technology and regulatory constraints into strategic value hypotheses, and steer outcomes across highly matrixed, regulated environments. Direct and validate: Competitive and technology intelligence to inform strategic positioning, function-level business needs and value hypotheses, prioritization of business-driven requirements shaping product and roadmap decisions & gaps analysis against existing solutions and operating models.
PhD/PharmD in a relevant scientific discipline with a minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
p>Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines. In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget.
The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring. Review and collaborate to develop fit-for-purpose study plans that define risk-based monitoring strategies and the related tasks necessary to oversee critical study data and process (e.g., clinical monitoring plan, centralized monitoring plan, protocol deviation management plan, and integrated quality risk management plan).
p>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring.
p>The Project Manager, Clinical Trials develops and implements comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or Division. In addition, this role will be responsible for coordinating all aspects of clinical trial feasibility, start-up, conduct and close-out of all Clinical Trials being conducted within their assigned Research Program or Division.
Under the direction of the Senior Director, Clinical Outsourcing, the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, and reporting process for Sun Pharmaceutical's clinical development programs. Leadership Skills: Strong leadership and team management skills, with a track record of effectively leading cross-functional teams.
li> Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility. Leading internal governance presentations to senior management and committees, communicating progress and key changes in product development strategy between stage gates, ensuring early alignment with line management, and facilitating issue escalation and cross-functional collaboration as needed for governance approval.
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history. Westat has an immediate opening for a Research Assistant to contribute to ongoing health research exploring genetic, clinical, and environmental factors influencing cancer in individuals, families, and broader populations.
Aligned with Rutgers University-New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and six centers and institutes that focus on cancer treatment and research, neuroscience, clinical and translational research, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Among the key duties of this position are the following: Assist with development and implementation of plans to recruit and retain study participants; assist with interviewing, recruitment and enrollment of human subjects for participation in clinical protocol; distribute and explain processes and goals of clinical studies to participants; assist with development of clinical study informational and educational materials; assist with informed consent process.