Clinical Trial Manager

Hiring Manager: VP, Clinical Development
Date Opened: February 2019

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.

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

Qualifications:

  • 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.