Job DescriptionJob Description
Clinical Project Manager
We’re looking for a Clinical Project Manager (CPM) to lead the execution of clinical trials from start-up through closeout. You’ll be the driving force ensuring studies are delivered on time, within budget, and in compliance with all regulatory and quality standards.
What You’ll Do:
* Lead cross functional project teams to deliver high-quality clinical trials in compliance with applicable regulations and quality documents.
* Work with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects
* Coordinate the development of protocols and protocol amendments in collaboration with sponsor, coordinating investigator and other experts
* Coordinate the development of study documents (e.g., informed consent forms, investigator brochures, monitoring plans).
* Participate in preparing study budgets, proposal documents
* Participate in bid defense meetings
* Handle contract/budget negotiation with sites
* Ensure deviations are managed appropriately and escalated to the sponsor as required
* Identify risks and develop and implement plans to mitigate risks in collaboration with team members and appropriate stakeholders
* Manage Data Safety Monitoring Board or other study committees
* Ensure appropriate oversight of vendors/suppliers
* Create and maintain project timelines for each project and track project’s progress
* Ensure close monitoring of the clinical trial budget
* Review study metrics for performance and quality with the team and management
* Report progress to the internal and external project team and stakeholders
* Ensures review of clinical Trial Master File for completeness
* Support audits
Requirements
* Master's degree in health science or equivalent
* Thorough knowledge of Good Clinical Practice
* 2+ years of experience Clinical Project Management
* Knowledge of GCP, ICH guidelines, regulatory requirements
* English fluent
* Good problem solving, decision making skills and situational judgement
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