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Senior Clinical Project Manager
Department: Clinical Development
Reports to: Director/Vice President
Location: Woburn Office or Remote
Summary of job description:
The Clinical Project Manager (CPM)/ Senior CPM is responsible for the management of all aspects of the clinical trial team activities for assigned project(s). The CPM in conjunction with the Vice President Clinical Development (VP CD) is accountable for achieving successful delivery of Replimune clinical team activities at the project level. This includes meeting company and regulatory requirements according to written processes and procedures, timelines, with quality and according to budget.
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
- Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
- Co-monitors as needed
- Develops and tracks study timelines, budget, and quality metrics
- Ensures appropriate clinical resources are available for the clinical project
- Ensures GCP and regulatory compliance is maintained
- Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Manages clinical projects from concept through clinical study report completion
- Oversees clinical research study conduct
- Manages, mentors, and develops direct reports
- Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources
- Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
- Participates in meetings with investigative sites, key opinion leaders and consultants as needed
- Plays a part in the analysis, summary, and reporting of clinical data through the course of the study
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
- Reviews and approves invoices from study vendors, investigators, consultants, etc.
- Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature
- Aides in the training and development of all clinical staff members
- Performs other duties as assigned
- Bachelor’s degree in life sciences, nursing license, or pharmacy
Experience and skill requirement:
- Five or more years of clinical operations experience as CPM, in the Pharmaceutical, Biotechnology, or CRO industry
- Experience leading cross-functional teams
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Therapeutic experience in oncology
- Computer skill should include proficiency with Microsoft Office software.