Clinical Trial Manager

Role Summary

Reporting to the Vice President, Clinical Operations, the Clinical Trial Manager supports the Clinical Operations team in the day-to-day management and execution of clinical trials. The role combines operational management and vendor oversight with a focus on study management, timelines, and budgets. The position is based in Boston, MA with a hybrid schedule (minimum of 2 days per week in the office).

Responsibilities

• Accountable for select aspects of clinical trial operations, including CRO and third-party vendor management, site management, and timeline and budget.
• Facilitate the request for proposal(s) process for selecting CROs or any new vendor and participate in the evaluation of potential services.
• Create or assist in the development and/or review of study documents and systems (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, etc.).
• Own and/or support study timelines and study status and proactively communicate updates and risks to timelines, quality, and/or budget-related items.
• Manage and monitor progress of study deliverables (ex. site activations, enrollment, etc.).
• Accountable for the creation, management, and negotiation of clinical site budgets and/or sponsor oversight of third parties responsible for these activities
• Accountable for study-specific budget activities including review and approval of vendor invoices, identification of out-of-scope activities and impact to overall budget, and support in monthly and annual forecasting.
• Accountable for the management and/or support of monitoring (trip report review, creation and compliance to plan, etc.)
• Assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
• Communicate study status both internally and externally in terms of study risks and mitigation plans and develop proactive contingency plans for study-level risks.
• Contribute or organize Investigator Meetings and CRA trainings.
• Provide expertise to study drug and clinical supplies forecasting and help oversee proper drug accountability and reconciliation.
• Oversee maintenance of study-related data and files in the Clinical Trial Management System (CTMS), if applicable, and electronic Trial Master File (eTMF).
• Contribute to a culture of inspection readiness and support internal and external audits and inspections.
• Ensure compliance with clinical trials requirements as well as any applicable Standard Operating Procedures (SOPs).
• Provide input and coordinate the development of best practices and functional SOPs.

Qualifications

• Bachelor’s degree required.
• 5-7 years of relevant Clinical Operations experience in the biotech/pharmaceutical industry, minimum of 2+ years independent trial management experience preferred.
• Excellent organizational and time management skills.
• Demonstrated communication skills skillfully and clearly articulating timelines, deliverables, and study questions/issues in cross-functional and multi-level teams.
• Prior experience successfully managing and developing study documents.
• Known for proactive problem solving and success meeting deadlines and demonstrating effective use of time to meet priorities.
• Able to manage multiple projects simultaneously, in a fast-changing environment.
• Knowledge of ICH/GCP and regulatory guidelines.
• Proven relationship and vendor management skills, with success moving through conflict.
• Ability to lead study teams and build cross-functional relationships internally and externally.
• Technical proficiency in MS applications such as Word, Excel, EDC, IVRS/IWR, etc.
• Highly respected for commitment to integrity, professionalism, and respect for patients.