Project Manager (Clinical Trials)
Boston, MAFull-TimeManagerProduct / Project
RESPONSIBILITIES:
- Oversee timelines, budgets, milestones, and deliverables for multiple WHOOP-sponsored studies; provide regular updates to leadership and external stakeholders.
- Lead daily or bi-weekly standups with cross-functional teams and manage task delegation and workload distribution across internal team members and vendors.
- Support study design, startup, monitoring, and close-out, including IRB submissions, Kick Off Meetings, documentation deliverables, and status tracking.
- Support the preparation, review, and approval of study protocols, informed consent forms, study plans, and other key documents.
- Collaborate with CROs, academic partners, and research sites to ensure smooth execution and high-quality data capture.
- Ensure adherence to GCP, ICH, FDA, and other applicable requirements; draft and finalize project management SOPs and templates for clinical trials.
- Identify project risks, propose mitigation strategies, and maintain proactive communication with stakeholders.
- Gather agenda items, lead meetings, and oversee meeting notes and follow-up actions across the Digital Health team.
QUALIFICATIONS:
- Bachelor’s degree in Life Sciences, Public Health, Nursing, or related field.
- 2–3 years of experience in clinical research project management, preferably in medical devices, software as a medical device, or digital health.
- Ability to manage and track 2–3 projects simultaneously.
- Strong knowledge of GCP, ICH, FDA, and related regulatory guidelines including ISO 14155.
- Excellent organizational, problem-solving, and communication skills with the ability to manage multiple stakeholders across technical and scientific domains.
- Proficiency with project management tools such as Jira, Confluence, Google Sheets, and Box.
- Passion for health, wellness, and WHOOP’s mission.
- Experience with wearable devices, digital biomarkers, or remote clinical trial designs preferred.
- Familiarity with data-driven health technologies or regulated medical devices preferred.
- PMP or equivalent project management certification (preferred but not required).
