Job SummaryC4 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 BackgroundRequired:
- 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.
CompensationThe 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.
