Senior Manager, Clinical Project Management (Project Delivery)

Position Overview
- Senior Manager, Clinical Project Management (Clinical Project Delivery CPD) provides hands-on operational management for one or more clinical trials, ensuring studies are executed on time, within budget, and in compliance with regulatory requirements.
- Primary accountability for study-level timelines, enrollment projections, budgets, and vendor performance.

Responsibilities
Clinical Project Delivery
- Lead cross-functional facilitation of clinical study teams through the trial lifecycle.
- Own study-level timeline development, tracking, and reporting.
- Develop and maintain enrollment graphs/dashboards with timely updates.
- Monitor delivery metrics (timelines, milestones, enrollment, budget adherence, vendor KPIs) and drive corrective action.
- Facilitate cross-functional planning/execution to ensure on-time, in-budget, quality delivery.
- Help CST identify operational risks and implement mitigation strategies.
Clinical Operations
- Champion accountability, collaboration, and continuous improvement.
- May contribute to initiatives; may mentor new/junior team members.
Vendor Management
- Manage CRO and central lab relationships/oversight.
- Support vendor identification, selection, contracting, and onboarding.
- Monitor vendor performance vs. contractual, timeline, quality/performance metrics.
- Support vendor governance, escalation, and issue resolution.
Quality/Regulatory Compliance
- Ensure adherence to ICH-GCP, FDA, EMA, and global requirements.
- Support inspection readiness and corrective actions with QA and CST.
- Help ensure data integrity and consistent trial conduct.
Cross-Functional Collaboration
- Align on program objectives and execution plans across clinical functions.
- Identify/mitigate study delivery risks; provide study-level operational input.
- Support IND/NDA/BLA submissions and health authority interactions as needed.
Budget and Resource Management
- Partner with Finance on study-level budget management/forecasting and change orders.
- Maintain oversight of Change Orders/Change Notifications; track/report budget adherence.

Qualifications
- Bachelor’s degree plus 6+ years clinical project management or clinical trial experience (biotech/pharma) or equivalent.
- 3+ years sponsor experience.
- Demonstrated experience managing/supporting clinical trial vendors (CROs, central labs).
- Working knowledge of timeline development, enrollment forecasting/tracking, and trial risk management.
- Experience with complex clinical trials (pharma/biotech).
- Demonstrated experience supporting/managing Trial Master Files.

Knowledge/Skills
- Strong clinical development/trial design and global regulatory framework knowledge (ICH-GCP, FDA, EMA).
- Experience managing CROs/vendors across the trial lifecycle.
- Solid project management skills; PMP a plus.
- Strong cross-functional stakeholder management without direct authority.
- Strong communication, negotiation, interpersonal skills; analytical/detail-oriented.
- Ability to prioritize/manage multiple tasks in fast-paced environments; highly professional, adaptable, accountable.