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Senior Clinical Trial Manager

4 months ago

Cambridge, United States Boston Pharmaceuticals Full time
Company Overview

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). Our second investigational program, BOS-342, is a targeted immunotherapy currently being studied in a Phase 1 clinical trial for the treatment of liver cancer. Position Summary:

The Sr. Clinical Trial Manager will support in managing and progressing all clinical programs at Boston Pharmaceuticals. The ideal candidate will be a highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

Roles & Responsibilities:
  • Manage contract research organizations and other external vendors to support clinical studies and ensure compliance with Boston Pharmaceuticals quality systems
  • Independently manage study activities, including study monitoring and performance management activities, data collection and reporting, and providing support as needed to the team of field champions.
  • 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, ICF(s), protocol(s), IB(s), 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
  • Facilitate internal/external meetings with key cross-functional teams

Qualifications:
  • BA/BS and +5 years of experience with direct clinical trial management, including management of vendors and CROs. 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
  • Experience integrating with cross-functional teams such as Regulatory, CMC, procurement, and/or finance preferred
  • Experience working with SmartSheets is a preferred
  • Resourceful and able to handle multiple and changing priorities
  • Ability to think creatively and independently and be proactive
  • Ability to understand the team's objectives and motivated to reach 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
  • Embraces and embodies Boston Pharmaceuticals' corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team