Manager, Clinical Project Management

The Manager, Clinical Project Management (CPM) is responsible for the creation and management of subset of Studies within the Post Approval Deliver Unit Portfolio. They will collect, consolidate and report budget, timeline and FTE actuals vs. plan and will identify potential issues for the trial through active management of the study schedule. They enable decision making by developing scenarios that reveal potential cost, timeline, and budget impacts. They play a key role in maintaining visibility to and documentation of current plans, scenarios under consideration, and changes in direction for study level plans.

Principal Relationships:

Internal: Trial Delivery Leader, Trial Delivery Manager, Trial Assistants, DAS Leaders, Trial Management Directors, representatives of Delivery Operations, Medical Affairs Stakeholders, representatives of other GD and non-GD Functions and Clinical and Project Management Teams

Principal Responsibilities:

• Create, manage, and maintain study schedules in PLW + For company Sponsored and Collaborative Studies; create initial study costing and support initial OOPS management up till FPI.
• Assure Clinical timelines in PLW align to mCTMS and to latest assumptions. Ensure proper resource demand is reflected
• Develop scenarios in PLW for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
• Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships. Manage scope control, FTE and OOP variances. + Provide necessary Portfolio Data Insights to the TA leads
• Provide necessary Portfolio Data Insights to the TA leads
• Provide support to Finance, Business Partners and Commercial Stakeholders
  

Additional Responsibilities may Include:

Provide support to Finance, Business Partners and Commercial Stakeholders

Education and Experience Requirements:

• BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 6 years in Pharmaceutical, Healthcare or related industries.
• Experience in and knowledge of the pharmaceutical development process.
• Strong Project Management experience (preferably in clinical trial management).
• Working knowledge of Project Management Systems, Methodologies & Tools.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of leading without authority and in muti-functional matrixed and global environments.
• Excellent decision-making, analytical and strong financial management skills are essential to this position.
• Operate and execute with limited supervision. Experience mentoring/coaching others.
• Strong project planning/management, communication and presentation skills are required.
• Knowledge of Clinical Research Operations with 4-6 years of experience managing multiple aspects of the execution of global clinical trials (Phases I-IV) is preferred.
• Travel up to 10% of the time, defined by business needs.
• Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology

Preferred Skills:

Analytical Reasoning, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution Focus, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Technical Credibility

Hybrid Wor