Senior Clinical Trial Manager at C4 Therapeutics Inc

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Full Time

Start Date

Immediate

Expiry Date

09 Jun, 26

Salary

200660.0

Posted On

11 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations Strategy, Clinical Trial Management, Oncology Trials, ICH/GCP Compliance, Budget Management, Vendor Selection, Risk Management, Cross-functional Team Leadership, Protocol Development, Data Cleaning, SOP Adherence, Project Management, Regulatory Standards, Forecasting, Issue Escalation

Industry

Biotechnology

Description

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. Your Background Required: * 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. Preferred: * Advanced degree in related discipline * Experience with Microsoft Project and/or Smartsheet Compensation The base pay range for this position at commencement of employment is expected to be between $181,550.00 and $200,660.00 annually; however, base pay offered may vary depending on multiple individualized factors, including job-related knowledge, skills, and experience. C4 Therapeutics is an Equal Opportunity Employer.

Responsibilities

The Senior Clinical Trial Manager will lead the successful execution of assigned oncology clinical trials from First in Human through Phase III, being accountable for operational strategy, day-to-day study execution, timeline adherence, budget management, quality, and regulatory compliance (ICH/GCP). This role involves leading the cross-functional study core team, managing CRO partners, overseeing all operational aspects from protocol concept to clinical study report, and managing risks and issues.