Clinical Program Operations Manager, Therapeutics & Innovation
About the role
For our client, we are seeking a Clinical Program Operations Manager, Therapeutics & Innovation to join the team of a leader in the Pharmaceuticals & Biotech space. This role will oversee the operational execution of clinical programs with a strong emphasis on oncology studies and cross-functional coordination. You will partner closely with clinical development, vendors, and site teams to keep timelines on track, manage risks, and support high-quality trial delivery from startup through database lock. This position also plays a key role in maintaining inspection-ready study documentation and driving governance across multiple workstreams.
Responsibilities
- Develop integrated study timelines and hold teams accountable for key milestones and dates
- Establish dashboards and reports for program status updates
- Identify risks, implement mitigations, and escalate issues when necessary
- Lead feasibility and site selection activities, including activation planning
- Manage site contracts, budgets, and essential documents
- Oversee CRO performance against KPIs and lead governance meetings
- Maintain the trial master file and ensure inspection readiness
Qualifications
- Bachelor's degree in life science or a related field; advanced degree preferred
- Minimum 5 years of clinical research experience, including 3 years managing oncology trials
- Accountability for at least one oncology study from startup through database lock
- Knowledge of ICH-GCP, FDA regulations, and trial master file compliance
- Proficiency in CTMS, EDC, IRT, and project management tools
- Experience managing CRO and site contracts and budgets
- Experience in small to mid-sized biotechnology companies preferred
Benefits
- Opportunity to lead oncology clinical trials and contribute to innovative research
- Collaborative work environment with cross-functional teams
- Exposure to cutting-edge clinical technologies and methodologies
- Professional growth opportunities within a small to mid-sized biotech company
- Flexibility with remote work and some travel to clinical sites
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $116,200 – $145,200 annually