Clinical Project Manager

Buck Institute•Novato, CA

2d•$90,000 - $100,000•Onsite

About The Position

The Clinical Research Core at The Buck Institute is seeking an experienced and motivated Clinical Project Manager to lead the day-to-day execution of two complex, multi-component clinical research studies, TIME and BETA, within a larger federally funded research program. These studies aim to advance our understanding of personalized medicine. The Clinical Project Manager will oversee study operations, staff, regulatory compliance, data and biospecimen quality, timelines, budgets, and coordination with internal and external stakeholders. This role will work closely with Clinical Research Co-Directors Dr. Newman, MD, PhD, a practicing geriatrician, and Dr. Brianna Stubbs, PhD, who brings more than 10 years of clinical research experience. Clinical research is a rapidly growing area at the Buck. Because the team is small, this position offers a high degree of ownership and visibility, combining leadership responsibility with direct involvement in study planning, conduct, and reporting.

Requirements

High school diploma/technical degree plus 8+ years of clinical research/project management experience in biomedical or clinical research; OR Bachelor's degree plus 4+ years of relevant experience; or Master's or PhD degree plus 2+ years of relevant experience.
Strong organization and ability to manage concurrent studies and priorities.
Proactive problem-solving, initiative, and consistent follow-through.
Prior supervisory and/or team leadership experience.
Strong written, verbal, and interpersonal communication skills.
Strong attention to deadlines and budget guidelines.
Experience preparing or submitting IRB protocols, amendments, or continuing reviews.
Clinical skills/background sufficient to train, mentor, and oversee quality for staff performing clinical procedures.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

Professional certification such as PMP, ACRP-CP, SOCRA CCRP, or equivalent.
Experience with project management software such as Wrike, MS Project.
Experience with EDC/data capture systems such as REDCap.
Phlebotomy certification/experience.
Experience in a nonprofit or academic clinical research setting.

Responsibilities

Lead day-to-day execution of assigned clinical trials, ensuring compliance with study protocols, GCP, ICH Guidelines, and Buck Institute Clinical Research SOPs.
Manage study collaborators and vendors, ensuring services and deliverables meet study needs and timelines.
Monitor participant enrollment, study milestones, and team capacity, and flag timeline, budget, or operational risks to Clinical Research Core leadership.
Coordinate protocol amendments, study close-out activities, team meetings, action items, and follow-up on deliverables.
Maintain IRB compliance, including continuing reviews, amendments, and required regulatory documentation.
Oversee timely and accurate data entry, query resolution, and good documentation practices across data capture systems.
Oversee safety reporting and escalation for adverse events, serious adverse events, adverse events of special interest, and protocol deviations.
Ensure biospecimens, study equipment, supplies, and other physical resources are organized, tracked, maintained, and available in accordance with protocol requirements.
Protect participant health information and sponsor-confidential information.
Lead, mentor, train, and support Clinical Research Associates, ensuring training, delegation, workload distribution, and back-up coverage are appropriately managed and documented.
Coordinate participant, staff, medical, room, equipment, and other clinical resource scheduling, adjusting plans as needed when priorities shift.
Communicate study progress, needs, and risks to internal and external stakeholders and collaborate with study medical staff to resolve operational or participant review questions.
Promote respect for cultural diversity and support culturally competent, multilingual recruitment.