Clinical Trial Manager

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Full Time Management Watertown, MA, US

8 days ago Requisition

Salary Range: $ To $ Annually

About C4 Therapeutics:

C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes.

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Job Summary

C4 Therapeutics is seeking an initiative-taking Clinical Operations professional to lead the successful execution of assigned clinical trial(s) in oncology from First in Human through Phase III. The Clinical Trial Manager will be responsible and accountable for planning and execution of day-to-day study operations including leading the cross-functional study core team, representing C4T in CRO study team meetings (and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs).

This is a hybrid role with expected regular presence at our Watertown, MA office.

Your Role

• Lead the execution of the day-to-day operational aspects of clinical study(ies) from protocol concept through clinical study report ensuring all trial deliverables are met according to established timelines, goals, budget, and quality standards.
• Collaborate with cross-functional team members on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s).
• Establish study timelines in collaboration with internal stakeholders and CRO partners and ensure development and accurate reporting of study metrics.
• Able to make recommendations and decisions regarding operational strategies to support study objectives.
• In collaboration with the Clinical Operations leadership, develop, manage, and track clinical trial budgets including providing ongoing reporting and forecasting to finance (inclusive of site budget review and approval, vendor budget review and approval, and third-party vendor invoice review).
• Manage the cross-functional study team and CRO/vendor(s) related to all aspects of clinical trial operations and continuously assess operational performance through carefully designed performance and quality indicators.
• Actively participate in training, and onboarding of study team members.
• Lead the identification, RFP/bid defense, evaluation, and selection of CRO/third party vendors.
• Develop strong relationships with Investigators and site staff as applicable.
• Manage issues and risks, including concise escalation and reporting to Clinical Operations leadership and other appropriate cross-functional team members.
• Support and/or lead preparation for Safety Review Committee (PI) Meetings, Investigator and/or Study Coordinator Meetings, Dose Escalation Meetings; may present content as needed.
• Contribute to the development of study documents including but not limited to the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, Case Report forms, responses to questions from IRBs and Ethics Committees, clinical sections of IND, CTAs, third party vendor manuals, study plans, and study guidelines/tools/trackers.
• Perform and contribute to clinical data cleaning as part of cross-functional data review team.
• Supporting protocol deviation identification, processing, categorization, and documentation.
• Contribute to Clinical Operations and organizational initiatives to build and optimize business procedures, tools, and guidance.
• Ensure consistent practices with the highest ethical standards in compliance with…