JOB SUMMARY
Providescustomer-focused leadership in managing clinical projects across variousphases, functional areas and assigned clinical staff.Accountable for the successful execution ofall assigned projects, where success includes on-time, on-budget,high-quality/compliant project results that lead to satisfied customers. Mayhave line management responsibilities.
JOB RESPONSIBILITIES
Project Leadership and Delivery:
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
- Lead project team to ensure quality, timelines and budget management.
- Accountable for the financial performance of each project.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Accountable for all project deliverables for each project assigned. Documentation and Reporting:
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for development and implementation of project plans.
- Plan, coordinate and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Business Development:
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- May participate in bid defense meetings where presented as potential project manager. Management:
- May be required to line manage other project management team members and clinical monitoring staff.