Senior Clinical Project Director, Global

Activities may include, but are not limited to: protocol and clinical study report development, vendor selection processes and vendor management, forecasting of clinical trial material or other supply needs, development of IWRS and/or EDC system specifications, development and management of timelines, project plans and budgets, study metrics reporting, development of study risk management and quality plans, involvement in investigator selection processes, etc. The Clinical Project Director may also manage or participate in certain day-to-day clinical trial activities (e.g., review and tracking of monitoring reports, clinical quality activities, review of site regulatory packets, review of data listings, quality review of other clinical/regulatory documents, participation in study recruitment initiatives, occasional co-monitoring with CRO staff, etc.) and will engage with cross-functional team members, vendor partners and clinical sites to ensure that trials are conducted in a manner that is timely, aligned with company goals, and in accordance with applicable standard operating procedures (SOPs) and applicable regulatory guidelines (e.g., ICH/GCP, etc.).

**Key Accountabilities**
- Responsible for planning, executing and successful completion of clinical research activities for clinical trials, including Phases I - IV and Investigator-initiated trials (IITs)
- Responsible for collating study metrics, developing and maintaining a comprehensive dashboard that is reported regularly to management and other stakeholders
- Work collaboratively with other members of the Clinical Operations team and/or CROs and vendor partners to establish and maintain study timelines, develop and maintain study risk management plans, communication plans, project plans etc.
- Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, ICH guidance, and internal Standard Operating Procedures. This may include contributions to and management of site Corrective and Preventative Action Plans (CAPAs), periodic co-monitoring visits with CRO personnel, and participation in site and/or vendor auditing
- Coordinate the completion of clinical and regulatory documents such as Clinical Trial protocols, Investigator Brochures, Clinical Trial Applications, etc. Write sections as directed. Perform and document quality review of these documents as needed
- Conduct study operational feasibility and risk assessments, identify issues, summarize findings and recommend course of action or course corrections and mitigation plans, as appropriate. This includes oversight and tracking of study timelines and progress and appropriate escalation of issues
- Work cross-functionally with other departments to forecast and maintain adequate clinical trial material or other study supplies
- Prepare study budgets. Manage the study to budget. Interface with Finance and Accounting Department regarding contract services to review invoices for accuracy and adherence to contracts, track payments made to service providers, and to contribute to the development of study-specific budgets and tracking tools
- Work with other members of the Clinical Operations team to accomplish corporate, departmental and project-specific goals and help manage day-to-day study operations (e.g., site regulatory packet review, monitoring report review, review and tracking of invoices, data listing review, development of study-specific plans, etc.)
- Ensure that proper study documentation is in place and that study issues are appropriately escalated to management, as needed
- Ensure development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Actively participate in bid defense, vendor selection and contract finalization meetings
- Responsible for the management of Clinical Research Organizations (CROs), and other service providers, and serve as the primary liaison between the company and the external team members.
- Oversee planning of investigator meetings with vendor partners; participate in the presentation of operational information
- Develop or review and provide feedback on all study plan documents including project management, safety management, monitoring, data management and statistical analysis plans
- Manage vendors according to scope, budget and adherence to contract. Ensure any change orders are vetted with management and in place with the vendor prior to engaging in out-of-scope work
- Assure proper study documentation is maintained and archived in the Trial Master Files. Periodically review eTMF and liaise with vendor partners to ensure inspection readiness. Work with vendor partners to properly document and archive files at study closure
- Ensure that studies are entered and updated within required databases and registration systems such as Clinical Trials.gov
- Manage post-market safety surveillance processes and requests for medical information, as necessary