Clinical Trial Manager
Hiring Manager: VP, Clinical Development
Date Opened: February 2019
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.
Roles & Responsibilities:
Select and manage contract research organizations and other external vendors to support clinical studies
Independently manage study activities, including: selection of investigators, study start-up activities including site initiation, study monitoring activities, data collection and close-out activities
Provide oversight of the CRO to ensure compliance with Boston Pharmaceuticals quality systems
Provide input to both the CRO and internal clinical development plans for the study, and ensure study team adherence to the plans
Develop and manage study timelines and project and track study enrollment
Contribute to the development of study related documents (contracts, ICFs, protocols, IBs, etc.)
Prepare clinical study budgets, monitor budgets for variances and approve invoices
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
BA/BS and 5 or more years of experience with direct clinical trial management, including management of vendors and CROs and ex-US trial experience is a plus
Experience in biotech/pharma/medical industry preferred
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
Approximately 10% travel, primarily involving trips to conferences for Investigator meetings or co-monitoring
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
Ability to think creatively and independently and be proactive
Ability to understand team’s objectives and goals and assist in reaching them.
Ability to exercise discretion when managing confidential information.
Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals.