Sr. Specialist, Clinical Project Management (3 positions)
Location: High Wycombe, Buckinghamshire, United Kingdom.
Job Function: R&D Operations – Clinical Trial Project Management.
Job Sub Function: Clinical Trial Project Management.
Job Category: Professional.
Purpose: The Sr. Specialist, Clinical Project Management is responsible for the creation and management of the integrated project schedule in Planisware. He/she will collect, consolidate and report budget, timeline and FTE actuals vs. plan, and identify potential issues for the trial(s) through active management of the study schedule.
Key Responsibilities
* Create, manage, and maintain integrated study schedule in Planisware (PLW) including creation of KEMs, Roadmaps, based on planning in PLW.
* Assure clinical timelines in PLW align to MSP schedule and coordinate the integrated clinical plan with CDT project plans. Ensure proper resource demand is reflected.
* Develop scenarios in PLW for budget, timeline, and FTE forecasting, while generating and analyzing situational operational scenarios.
* Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships. Manage scope control reporting, and FTE/OOP variances.
* Ensure key decisions, actions, risks, issues, lessons learned, and trial governance are reflected in the integrated trial plan in PLW.
* Provide support for team‑based reporting (i.e., the PLW team lists).
* Translate operational strategy into PLW and translate PLW output back to the study team.
* Foster employee engagement, inclusion, and Credo Behaviors.
Qualifications / Requirements
Education: BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). (Required)
Experience:
* Minimum of 4 years of experience in Pharmaceutical, Biotechnology, Healthcare or related industries. (Required)
* Strong Project Management experience (preferably in clinical trial management). (Preferred)
* Experience leading without authority and in multi‑functional matrixed and global environments. (Preferred)
* Excellent analytical skills and exposure to financial management are important to this position. (Preferred)
* Operate and execute with limited supervision. (Preferred)
* Ability to support and participate in the hiring, training, development, and evaluation of staff on a regular basis. (Preferred)
* Knowledge of Clinical Research Operations with 2‑3 years of exposure to multiple aspects of the execution of global clinical trials (Phases I‑IV). (Preferred)
Other:
* Travel up to 10% of the time, defined by business needs.
Preferred Skills
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP).
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