Clinical Operations Program Manager

Role Overview: The Clinical Operations Program Manager (Global Feasibility Lead) is responsible for providing operational support for clinical development programs and trials, focusing on early viability, feasibility, allocation, and site selection activities.

Scope of Activities:

• Conduct early viability and feasibility assessments.
• Validate and refine allocation strategies, including scenario planning and risk management.
• Perform re-feasibility assessments as needed.
• Analyze external and internal data to validate and refine strategic allocation of assigned trials, ensuring alignment with program allocation strategy.
• Develop evidence-based scenario planning to drive realistic project timelines.

Major Accountabilities:

• Support the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection, and recruitment plans scenarios for the assigned programs and trials.
• Prepare and coordinate briefing information, training resources, and other materials.
• Provide project planning support and manage key deliverables.
• Assemble actions, output summaries, and minutes for follow-up tracking.
• Lead feasibility activities, such as feasibility survey consolidation and analysis, and review data insights with feasibility teams.
• Coordinate and manage the editing, technical support resolution, and distribution of feasibility questionnaires at the trial level between sites, countries, and globally. Ensure feedback from feasibility assessments is addressed.
• Conduct scenario planning and provide outputs from Footprint Optimizer (FPO) to assist with timeline review, validation of key data, and support for Final Allocation Curve as part of handover.
• Assist in portfolio management activities, including tracking tollgates and preparing for risk review sessions. Draft risk slides and SPF overviews of current feasibility work for senior management.
• Ensure required end-of-feasibility information entry and compliance records into internal systems (e.g., IMPACT planning; archiving for Trial Master File and regulatory documents in CREDI/Subway).
• Manage early timeline and pricing assessments, liaising with Health Insights and/or performing competitive intelligence searches to build assumptions (includes archiving outputs in team repositories).
• Manage logistics for team meetings, including agenda preparation, minutes, and follow-up on action items.

Ideal Background:

• Bachelor's degree preferred.
• Fluent in English, both written and verbal.
• At least 4-5 years of experience in the end-to-end global feasibility process in clinical trials.
• Experience in creating feasibility dashboards for stakeholders/clients.
• Excellent communication skills.
• Strong project planning and organizational capabilities.
• Proven ability to work independently or in a team setting to meet goals within budget, timeline, and compliance expectations.
• Knowledge of Good Clinical Practice and understanding of the overall drug development process.
• Strong skills in MS Office Suite, including MS Teams, Excel, Word, and expert-level PowerPoint slide creation and formatting.