Clinical Trial Manager

C4 Therapeutics, Inc.; Massachusetts; Hybrid; USD 139,000 - 153,000; Full time

Job summary

C4 Therapeutics is seeking an experienced Clinical Trial Manager to lead oncology trials from First in Human through Phase III. The role requires managing day-to-day operations, cross-functional collaboration, and ensuring timelines, budgets, and quality with CRO partners.

The position is hybrid, with regular work at the Watertown, MA office. Ideal candidates have a strong background in clinical operations, regulatory knowledge, and a proven ability to drive study milestones while maintaining

Qualifications

• Bachelor’s degree in health/life sciences or related field.
• Minimum five years of progressive clinical operations experience, including trial management across development phases.
• Experience coordinating CROs and third-party vendors.
• Knowledge of FDA regulations and ICH/GCP guidelines.
• Ability to lead cross-functional teams and manage study budgets.

Responsibilities

• Lead day-to-day operational aspects of clinical studies from protocol through study report.
• Collaborate with cross-functional team members on study operations strategy.
• Establish study timelines with stakeholders and CROs; report metrics.
• Develop and manage study budgets with finance; vendor invoice reviews.
• Identify, evaluate, and select CRO/third-party vendors; manage vendor relationships.
• Prepare for Safety Review Committee meetings and investigator meetings as needed.
• Contribute to study documents such as protocols, CRFs, and ICH/IND/CTAs documents.
• Ensure compliance with SOPs, ICH/GCP, and local regulations.

Skills

Trial management

Cross-functional leadership

Budget management

FDA regulations

ICH/GCP knowledge

Education

Bachelor’s degree in health/life sciences

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Trial Manager

Full Time Management Watertown, MA, US

8 days ago Requisition ID: 1144

Salary Range: $138,566.00 To $153,118.00 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. For more information, please visitwww.c4therapeutics.com .

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 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 five years of progressive clinical operations experience, including trial management across phases of development at a pharmaceutical or biotechnology sponsor, serving as a primary point of contact for CROs and third-party vendors.
• 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 contributing to clinical operations strategy and developing and/or input into key clinical trial plans.
• 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.
• Demonstrated effective problem-solving, and risk management to prevent and overcome complex safety and compliance related issues during clinical study implementation.

Preferred:

• Experience with oncology clinical trial management and/or global clinical trials.

Compensation

The base pay range for this position at commencement of employment is expected to be between $138,566.00 and $153,118.00 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.