Create, manage, and maintain integrated study schedule in MS Project, including KEMs, Roadmaps, and critical path visualization aligning in Planisware (PLW).
Clinical timelines in PLW align to MS Project schedule and coordinate the integrated clinical plan with Compound Development Team (CDT) project plans. Ensure proper resource demand is reflected.
Develop scenarios 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.
Document key decisions, actions, risks, issues, and lessons learned, as well as maintain applicable trial governance documentation.
Provide support for team-based reporting.
Qualifications
Minimum of BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is required.
Experience And Skills
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.
