Associate Director, Clinical Trial Manager

Responsibilities:

• Perform day to day management and oversight of assigned clinical trial to ensure deliverables are met timely and within budget
• Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Develop and maintain study level timelines and budget with internal leadership and CRO
• Work with CRO to provide monthly metrics report to track against timelines (i.e. study dashboard report)
• Responsible for ongoing study communication and escalation of study-related issues as required
• Develop and adhere to vendor oversight plans
• Contribute to or author relevant study documents such as the protocol, informed consent form, investigator brochure, clinical study reports and other documents and plans, as appropriate
• Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)).
• Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews
• Oversight and review of data management outputs
• Responsible for protocol deviation review and listing
• Participate in and provide feedback during RFI, RFP and bid defense process for new studies
• Participate and review quality plans and audit reports for the study and provide oversight of CAPA resolution with the CRO, vendors and sites, as needed
• Oversee any subcontracted vendors through CRO
• Review and track monitoring report issues, GCP compliance concerns and monitor performance; oversight of timely issue resolution at sites; Perform and/or coordinate sponsor oversight visits at the clinical sites to ensure quality of monitoring and sites adherence to GCP
• Oversight of the eTMF for the trial and will ensure an audit/inspection ready Participate and review SOPs for clinical operations and other functional areas as needed
• Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
• Support during relevant inspections (e.g., FDA)
• Assist CRO with planning of Investigator Meetings and associated travel
• Facilitate review of clinical trial agreements
• Identifies potential risks form study and works with the team to resolve any issues
• Participates in UATs, e.g., EDC, IRT
• Mentoring assigned Clinical Trial Coordinator

Minimum Requirements:

• Bachelor's degree in the Life Sciences or equivalent is required
• 8 years of experience in clinical operations is required
• Ability to build strong relationships with the sites and CRO including providing feedback as well as oversight
• Passion for working in a small company environment - including being self-motivated and proactive
• Ability to think of big picture as well as being adept at detail-orientation
• Up to 20% travel may be required