Sr. Clinical Trial Manager (REMOTE)

Position Summary:

The Clinical Trial Manager will independently oversee clinical studies from concept to close-out. The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

Job Responsibilities:

• Manage contract research organizations (CRO) and other external vendors to support clinical studies and ensure compliance with company quality systems
• Independently manage and oversee study activities, including: selection of investigators, study start-up activities including site initiation, study monitoring activities, data collection and close-out activities
• Provide input to both the CRO and internal clinical development plans for the study, and ensure study team adherence to the plans, as needed and appropriate per study needs
• Develop and manage study timelines and project and track study enrollment
• Contribute to the development of study related documents (contracts, ICF(s), protocol(s), IB(s), etc.)
• Prepare clinical study budgets, monitor budgets for variances and approve invoices, as needed
• Address and escalate relevant operational issues to key stakeholders
• Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate appropriately
• Facilitate internal/external meetings with key cross-functional teams

Qualifications:

• BA/BS and 3 or more years of experience with direct clinical trial management, including management of vendors and CROs and ex-US trial and oncology experience is a plus
• Experience in biotech/pharma/medical industry preferred
• Oncology experience required
• Phase 1 experience required
• Working knowledge of GCP, ICH and relevant CFRs is required
• Experience in early-stage clinical development is strongly preferred
• Project management skills, effective communication (written and verbal), adaptability and self-motivation are required attributes
• Strong time management skills; ability to prioritize multiple tasks efficiently
• Experience integrating with cross-functional teams such as Regulatory, CMC, procurement, and/or finance a plus
• Experience with Microsoft Project is a plus
• Resourceful and able to handle multiple and changing priorities