This full-time position is responsible for ensuring the integrity, quality, and compliance of clinical trials conducted at Astera Cancer Care.
Job Description:.
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.
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.
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.
p>How You Will Add Value:
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.
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>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.
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.
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.
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.
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.
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.
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.
p>Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
p>• 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>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.
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. 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).
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.