Senior Clinical Trial Manager

C4 Therapeutics Inc•Watertown, MA

About The Position

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 www.c4therapeutics.com . 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 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). Your Role Lead the execution of the day-to-day operational aspects of clinical studies from the protocol concept through the clinical study report. Manage assigned clinical trial(s), timelines, and resources with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives. Accountable for the development, management, and tracking of clinical trial budgets including providing ongoing reporting and forecasting to finance (including site budget review and third-party vendor invoice review). Collaborate with cross-functional team on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s). In collaboration with CRO partners, establish study timelines and ensure accurate tracking and reporting of study metrics. 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 t 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, onboarding and mentoring of study team members (both internal and external as appropriate). Lead the identification, RFP/bid defense, evaluation, and selection of CRO/third party vendors. Develop strong relationships with Investigators and site staff. Manage issues and risks, including concise escalation and reporting to senior management 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 internal SOPs, ICH/GCP, and local regulations. Represent Clinical Operations to internal and external stakeholders including key opinion/thought leaders.

Requirements

A Bachelor’s Degree in health/life sciences or related field, with a minimum of six years of clinical operations experience, including significant experience in oncology trial management from Study Start-up, maintenance, and closeout) at a pharmaceutical or biotechnology company, and/or CRO.
Demonstrated knowledge of clinical operations methodologies, FDA Regulations, ICH/GCP guidelines in clinical trials, and related organizational, project management, and leadership capabilities.
Demonstrated experience with developing clinical operations strategy and developing and/or input into key clinical trial plans.
Outstanding ability to communicate and collaborate in an open and clear manner with varied stakeholders, listening effectively and inviting response and discussion with internal partners and external service providers.
Proficient in strategic insight, decisiveness, strong judgment, innovation, effective problem-solving, and risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.

Nice To Haves

Advanced degree in related discipline
Experience with Microsoft Project and/or Smartsheet

Responsibilities

Lead the execution of the day-to-day operational aspects of clinical studies from the protocol concept through the clinical study report.
Manage assigned clinical trial(s), timelines, and resources with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
Accountable for the development, management, and tracking of clinical trial budgets including providing ongoing reporting and forecasting to finance (including site budget review and third-party vendor invoice review).
Collaborate with cross-functional team on the development, planning, and execution of the clinical trial operations strategy for assigned clinical trial(s).
In collaboration with CRO partners, establish study timelines and ensure accurate tracking and reporting of study metrics.
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 t 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, onboarding and mentoring of study team members (both internal and external as appropriate).
Lead the identification, RFP/bid defense, evaluation, and selection of CRO/third party vendors.
Develop strong relationships with Investigators and site staff.
Manage issues and risks, including concise escalation and reporting to senior management 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 internal SOPs, ICH/GCP, and local regulations.
Represent Clinical Operations to internal and external stakeholders including key opinion/thought leaders.