Clinical Project Manager (CPM)

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
• Manage 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)
• Provides input in the development of Clinical Operations quality systems, including SOPs
• Recommends and implements innovative process ideas to impact clinical trials management
• Manages the activities of resources both internal and external contractor/vendors, ensuring Good Clinical Practices (GCP) compliance ais maintained throughout
• Provides direction to the clinical sites either directly or with other Clinical Operation staff to establish consistent and successful clinical trial compliance and oversight across clinical programs
• Manages internal staffing and performance including assisting in hiring, training, and performance reviews to ensure the efficient operation of the functions within Clinical Operations

Essential Skills and Traits:

• A working understanding for the nuances associated with neuroscience and ideally rare disease clinical trials which are different to large indication/other indication development
• A clear understanding of the components of the clinical drug development pathway from IND preparations, first in human, clinical proof of concept, registration directed pivotal trials through to NDA filing
• Participation in large multi-center and/or global trials
• Strong Clinical Operations or Project Management experience
• Working understanding of US and global regulations and guidelines (FDA, EMA, ICH)
• Experience working in small companies, or an appreciation of and desire to work in a small company environment
• A self-assured team player who will work well with all other functional areas and can effectively interact with individuals at all levels of the organization and develop a cohesive relationship among the team
• Ability to work under pressure and timeline constraints.
• Ability to manage multiple competing priorities, being able to rapidly gather, assimilate and disseminate information on critical project components and milestones, and to translate to internal or external staff assigned to projects
• Detail focus with ability to manage technical/scientific aspects as well as operational components of logistics, timing and quality

Qualifications:

• BS/BA in the life sciences or in a related field preferred
• Permitted to work in the United States
• Strong organizational, written, and verbal communication skills