Senior Clinical Trial Manager Somerset, NJ
Title: Senior Clinical Trial Manager
Job Type: Contract (1 year minimum)
Primary Location: Somerset, NJ or Remote
Vignetic is looking for a Senior Clinical Trail Manager who will be committed to quality, driven by excellence, and dedicated to experimentation. This candidate will work closely with the Director and Associate Director of Clinical Research Operations and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality. Mentoring and management of Clinical Trial Assistant (CTA) staff.
Roles & Responsibilities:
- Responsible for all aspects of study set up, management and oversight of pipeline studies. Job duties also include CRO oversight and point of contact for clinical study project management, communications, and daily operations for the clinical INDs.
- Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required.
- Demonstrated ability to drive end to end clinical trial activities: i.e. experience in all aspects of study start-up and oversight of study execution and close out.
- Develop and manage comprehensive study timelines and metrics; clinical operation efficiency tools, management/oversight of external vendor deliverables reports and budgets.
- Report on all aspects of the study progress at a granular level to Operations management. Effective, consistent & regular tracking of project(s).
- Collaborates with following groups across the trial program: Data Management, Statistics, Clinical Supplies, Safety, etc.
- Participates in all CRO study-related calls and meeting, tracks actions, escalates issues and oversees all aspects of daily study operations.
- Lead and co-lead internal study operational calls and meetings.
- Collaborate with the Sr. Director and Associate Director of Clinical Operations on study budget development, financial forecasting/budgeting management and vendor & site payments.
- Ability to identify issues and risks, develops, and manage mitigations and/or escalate risks appropriately.
- Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.
- Efficient process and system thinker.
- Daily interaction with the study CRO project manager and Clinical Trial Manager.
- Collaborates in the preparation and/or review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).
- Ensures audit-ready condition of clinical trial documentation including central clinical files.
- Collaborates in the writing and review of study protocols, informed consents, and amendments.
- Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs.
- Ensure Trial Master Files (TMFs) are properly maintained.
- Ability to manage and collaborate on complex protocols within a matrix environment (Data Management, Safety, outsourcing and vendor alliance management).
- Critical thinking skills for problem-solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
- Comfortable multi-tasking in a fast-paced small company start-up environment and able to adjust workload based upon changing priorities.
- Adaptable/flexible, self-starter (willing and able to adjust to multiple demands, sometimes beyond Job descriptions and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
- Excellent team player but also independently without significant oversight.
- Strong Self-Starter and hardworking individual, willingness, and ability to fill functional gaps in a small organization.
Essential Skills & Requirements:
- Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline preferred.
- 7+ years of managing studies at a pharmaceutical, biotech or CRO.
- 3+ years of oncology clinical research experience required.
- Cellular/Gene therapy (CAR-T) experience a plus.
- CRO/Multiple vendor oversight on complex studies experience required.
- Demonstrated ability to multi-task, wear multiple hats and manage high performance demands.
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Project Management (CRO/biotech) experience a plus.
- Regulatory authority inspection experience a plus.
- Experience managing multiple studies.
- Experience managing complex or global trials preferred familiarity with regulatory process in global studies.
- Ability to travel as necessary (approximately 10 – 15 %).