About This Role
The Project Manager is a proven leader in clinical program management within the clinical research industry, responsible for managing, executing, and reporting on clinical study operations. This position provides leadership and support to multidisciplinary project teams, both internally and externally. Responsibilities encompass the overall management of a project, including budgeting, timeline adherence, internal and external communications, and project deliverables.
Responsibilities
- Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities
- Manage and execute the overall project scope, budget, and timelines
- Identify project success factors for analysis, reporting, and tracking
- Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements and contractual agreements
- Lead the development of study-specific protocols, consent forms, and other trial-related materials as required
- Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
- Participate in the review of clinical data for analysis
- Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs)
- Serve as a liaison between clients and the internal team to ensure project-specific information and ongoing updates are proactively communicated
- Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device
- Monitor adherence to project contract and budget
- Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study projects
- Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed
- Support the management and oversight of clinical study-related vendors
- Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements
- Provide therapeutic training and guidance to the clinical team
- Enhance department and organization reputation by participating in departmental or corporate initiatives
- Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations