Senior Clinical Project Manager

About the role

The Senior Clinical Project Manager is responsible for leading the strategic planning, execution, oversight, and delivery of complex global clinical trials and programs across multiple phases of development.

The Sr. CPM serves as the operational leader for assigned studies, partnering cross-functionally with Clinical Development, Medical, Regulatory, Data Management, Biostatistics, Quality, Safety, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.

The Sr. CPM provides proactive risk management, drives operational excellence, influences study and program strategy, and may mentor junior Clinical Operations staff.

Essential Functions

• Manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications;
• Reviews vendor reports, budgets, and metrics; prepares and presents project debriefings, as required;
• Plans, executes, and attends/manages study-specific meetings as applicable.
• PARTNERS WITH THE CLINICAL RESEARCH ORGANIZATION ("CRO") TO ENSURE THAT PATIENT ENROLLMENT AND DATA COLLECTION ARE COMPLETED IN ACCORDANCE WITH STUDY TIMELINES AND OBJECTIVES;
• Escalates risk to timelines and budget as needed;
• REVISES SCOPE OF SERVICE AGREEMENTS, BUDGETS, PLANS AND DETAILED TIMELINES, AND ENSURES THAT PERFORMANCE EXPECTATIONS ARE MET.
• OVERSEES ALL STUDY-LEVEL DATA MONITORING ACTIVITIES; REVIEWS VISIT REPORTS; ATTENDS MONITORING VISITS AS REQUIRED.
• RESPONSIBLE FOR MONTHLY PROTOCOL DEVIATION (PD) REVIEW, INCLUDING OVERSIGHT OF CRA DOCUMENTATION AND COLLABORATION WITH MEDICAL MONITOR FOR MEDICAL REVIEW.
• WORKS IN A TEAM ENVIRONMENT COMPRISING OF CLINICAL OPERATIONS, REGULATORY, TECHNICAL OPERATIONS, QUALITY, AND CROs TO ASSESS AND MEET DATA MANAGEMENT NEEDS; INCLUDING ENSURING DATA IS ACCURATELY COLLECTED IN AN EFFICIENT AND TIMELY MANNER.
• USES OPERATIONAL AND THERAPEUTIC KNOWLEDGE TO OPTIMIZE TRIAL DESIGN AND EXECUTION; WORKS WITH THE STUDY TEAM TO DESIGN CLINICAL TRIAL PROTOCOLS AND ASSISTS IN DEVELOPING/MANAGING AN ONGOING DATA REVIEW PLAN TO ENSURE DETECTION OF DATA TRENDS AND TO ENSURE STUDY OBJECTIVES ARE MET; SUPPORTS THE CREATION OF THE ICF TEMPLATE, CRFS, ETC.
• PREPARES AND/OR REVIEWS STUDY-RELATED DOCUMENTS.
• PREPARES/REVIEW SITE STUDY DOCUMENTS (I.E., SITE-SPECIFIC INFORMED CONSENT, STUDY TOOLS/WORKSHEETS, INVESTIGATOR CONTRACTS, AND SITE PAYMENTS).
• RESPONSIBLE FOR THE MANAGEMENT OF STUDY BUDGET AND MAINTAINS IT WITHIN FINANCIAL GOALS; INCLUDING REVIEW OF INVOICES AGAINST APPROVED BUDGET.
• ENSURES ALL CLINICAL TRIALS ARE EXECUTED IN COMPLIANCE WITH ICH/GCP GUIDELINES/REGULATIONS AND APPLICABLE SOPs: PARTICIPATES IN THE PLANNING OF QUALITY ASSURANCE ACTIVITIES AND COORDINATES RESOLUTION OF AUDIT FINDINGS; ENSURES AUDIT-READY CONDITION OF CLINICAL TRIAL DOCUMENTATION INCLUDING CENTRAL CLINICAL FILES; REVIEWS MONITORING REPORTS TO ENSURE QUALITY AND RESOLUTION OF SITE-RELATED ISSUES; COORDINATES AND ASSISTS IN THE PLANNING OF REGULATORY OR ETHICS COMMITTEE ACTIVITIES, AS APPROPRIATE.
• PARTICIPATES IN THE SELECTION, TRAINING, AND EVALUATION OF STUDY PERSONNEL (CONTRACT AND INTERNAL) TO ENSURE THE EFFICIENT OPERATION OF THE FUNCTION.

Qualifications

• Bachelor’s Degree in a life science or a health-related field
• 8+ years of progressive clinical operations/project management experience within biotechnology, pharmaceutical, or CRO environments.
• 5+ years leading Phase I–III clinical studies.
• Demonstrated experience leading global, multicenter clinical trials.
• Experience managing CROs and multiple vendors.
• Experience with study budget development, forecasting, and financial oversight.
• Prior experience supporting regulatory submissions, inspections, and audits.