About the job
Clinical Project Manager
Position Overview: The Clinical Project Manager (PM) serves as the primary contact for all project-related activities. This role involves training team members and overseeing project execution to align with the Sponsor's objectives, ensuring timely delivery, budget compliance, and adherence to Ergomed's quality standards and Good Clinical Practice principles.
Key Responsibilities:
- Assist the Business Development team in crafting study proposals based on client requests and contribute to Bid Defence meetings.
- Act as the main point of contact for the Sponsor throughout the project lifecycle.
- Assess resource needs for the project and collaborate with the Resource Manager, Office Director, and Functional Head to secure necessary resources.
- Ensure all project team members (Monitors, Site Managers, CTAs, Data Managers, etc.) are adequately trained in GCP, SOPs, protocols, and study-specific procedures.
- Organize and lead project meetings, including kick-off and investigator meetings, as well as regular updates during project execution.
- Contribute to the development of study documents such as protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports (CSRs).
- Review and revise project management plans, communication plans, and risk management strategies, incorporating key performance indicators (KPIs) to ensure quality and budget adherence.
- Establish a shared folder for study documentation to enhance collaboration and monitoring of project status and KPIs.
- Maintain quality assurance throughout the study and implement corrective measures as necessary.
- Oversee vendor selection and qualification processes as per contractual agreements.
- Identify and contract investigational sites as per project requirements.
