https://www.linkedin.com/jobs/view/2536739238/
ESCAPE Bio is a biopharmaceutical company focused on the discovery and development of small drug molecule therapies to treat genetically defined neurodegenerative diseases.
Position Overview
The Clinical Project Manager (CPM) will be responsible for the operational management of clinical development program(s) in order to ensure delivery on time, within budget, and of high quality in compliance with ICH/GHP, Regulatory Authorities’ regulations/guidelines, and applicable Standard Operating Procedures (SOPs). This person interacts with various internal personnel and external consultants and vendors as well as clinical study sites. Responsibilities may include operational direction of one or more clinical cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams.
**Responsibilities, including but not limited to: **
- Manages, tracks, and troubleshoots a series of related clinical trials within a clinical development program
- Manages Clinical Operations personnel
- Manages cross-functional study teams
- Partners with management to develop, manage, adjust, and revise program timelines and budgets
- Participates in protocol, CRF, Clinical Study Report preparations, and NDA submission as appropriate
- Participates in and implements clinical development program strategies
- Communicates operational aspects of studies to management
- Ensures that the clinical operational plan is consistently applies across all studies
- Recommends additional resources based on need to meet study milestones and timelines
- Proactively identifies potential risks and development/implementation of actions to avoid or mitigate
- Actively contributes to the development of RFPs and selection of CROs/vendors for outsourced activities
- Develops and manages CRO/vendor SOWs including review/approval of vendor invoices
- Works with CROs to develop and revise scope of service agreements, budgets, plans and detailed timelines, and that performance expectations are met
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, trial master files)
