Senior Clinical Trial Manager - Watertown, United States - C4 Therapeutics Inc

Description

Job Description

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. For more information, please visit

Job Summary:

C4 Therapeutics is seeking a highly motivated experienced Clinical Operations professional with hands-on expertise 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 the development of clinical trial operational strategy and leading planning execution of day-to-day study operations, leading the cross-functional Study Management Team (SMT), managing outsourced CRO and third party vendor activities, and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs).

Your Role:

• Leading the execution of the day-to-day operational aspects of clinical studies from the protocol concept through the clinical study report.
• Accountable for delivery of assigned clinical trial(s), budgets, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Collaborate with the Medical Director and cross-functional teams on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s).
• Lead and manage day-to-day execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
• Manage the cross-functional study management 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.
• Effective management of issues and risks, including concise escalation and reporting to senior management, appropriate teams, and collaborating functions.
• Supporting and/or leading preparation for Safety Review Committee (PI) Meetings, Clinical Research Coordinator Meetings, Dose Escalation Meetings, and may present content as needed.
• Establish study timelines and ensure accurate tracking and reporting of study metrics and managing of study tracking tools to support trial planning and execution.
• Develop and execute Study Operational and Vendor Management/Oversight plans.
• Lead the identification, RFP/bid defense, evaluation, selection, and management of CRO/third party vendors including execution of vendor oversight plans.
• Lead SMTs, SIVs, or other study meetings as needed.
• Accountable for the development, management, and tracking of clinical trial budget as well as accuracy of trial information; provide ongoing reporting and forecasting to finance (includes site budget review and third-party vendor invoice review).
• Manage and provide documented oversight of CRO and third-party vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines and enrollment.
• 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.
• Performing and contributing to clinical data cleaning as part of cross functional data review team.
• Supporting protocol deviation identification, processing, categorization, and documentation.
• Collaborating with Quality to conduct inspection readiness checks/quality reviews of the TMF to ensure trial documentation is in audit-ready state.
• Actively participating in training/onboarding of study team members (internal/external).
• Working with the COPL in assigned site close out activities as needed.
• Overseeing and mentoring Clinical Trial Associate and other junior Clinical Ops staff.
• Develop strong relationships with Investigators, site staff, and CRO partners.
• Contribute to Clinical Operations/Organizational initiatives to build and optimize business procedures, tools, and guidance.
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, ICH/GCP, and local regulations.
• Represent clinical operations to internal and external stakeholders including key opinion/thought leaders.

Your Background:

• BA/BS degree (advanced degree preferred) in health/life sciences or related field.
• Minimum of 4-10 years of drug development experience, particularly in clinical trial management and independent oncology clinical operations in all phases of clinical trial execution (Start-up, maintenance, closeout) at a pharmaceutical company, biotech company, and/or CRO.
• Robust experience in oncology required.
• Demonstrates extensive knowledge of clinical operations methodologies, organizational, project management, and leadership capabilities as well as strategic insight, decisiveness, strong judgment, and effective problem-solving.
• Ensures a consistent, standardized approach to operational activities and clinical project management. Champions continuous quality improvement by evaluating methods and approaches and recommending efficient and/or novel approaches.
• Demonstrated experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, and CRO/vendor oversight plans.
• Experience with managing and demonstrating oversight of CROs, vendors, and consultants.
• Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project and/or Smartsheet (preferred).
• Outstanding ability to communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers.
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.
• Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
• Comfortable in a fast-paced, results-driven, highly accountable environment with large potential impact.
• Efficient and effective time management skills with ability to successfully manage competing priorities.
• Knowledge of GCP, ICH, and FDA regulations.
• Some travel required.

C4 Therapeutics is an Equal Opportunity Employer.