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 leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines that 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. C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases.

Our Opportunity:

C4 Therapeutics is seeking a highly organized and experienced Clinical Documentation Specialist to support the Clinical Operations department as the primary person responsible for supporting the study management team (SMT) with document management, conducting Quality Control checks (QC), and filing of documentation in the Veeva electronic Trial Master File (eTMF). This position will work closely with SMT Functional Area Leads (FALs) and the Quality team.

The Role:

• Support Clinical Operations and the SMT with day-to-day lifecycle management of documentation including filing and classification of trial artifacts in the Veeva eTMF for clinical trials
• Serve as TMF contact and Subject Matter Expert for the clinical study team and support cross-functional departments including TMF process education to ensure high quality documentation
• Classify and index electronic TMF (eTMF) and clinical development documentation with accurate attributes and metadata according to company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index
• Monitor TMF health/report metrics throughout the study according to TMF plan and deliver KPI reports and dashboard to the study team
• Execute planned and ad hoc Quality Control (QC) procedures, identify and record quality issues; provide solutions and resolve issues with relevant FALs and in accordance with C4T SOPs; identify documentation trends and perform corrective training to SMT members as needed based on TMF QC findings
• Support audit/inspection activities, internal Compliance/Quality procedures and process improvement
• Executes Change management to ensure consistent application and best practices of revised standards, processes, and systems functionality across study teams
• Develop, review, or update trial-level TMF Plans and Trial Index.
• Providing best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives

Your Background:

• Bachelor's Degree with 4 years clinical experience including organizing and coordinating electronic Trial Master Files for clinical trials
• High level of competency with Veeva VAULT eTMF and knowledge of the TMF Reference Model, supported by DIA
• Excellent organizational and problem-solving skills, able to work independently
• Efficient and effective time management skills with ability to successfully manage competing priorities.
• Strong attention to detail
• Familiarity with TMF regulations: ICH GCP, EMA Clinical Trial Regulation and Guidance, the MHRA Gray Guide, and FDA 21 CFR Part 11 as applicable to a study (or the countries where a study is conducted).
• GCP inspection experience preferred.
• Able to quickly learn and adapt to new systems and technology
• Excellent written and verbal communication skills including excellent command of English

C4 Therapeutics is an Equal Opportunity Employer. 

C4 Therapeutics is committed to creating a safe and healthy workplace. To ensure the safety and health of our employees, C4 Therapeutics requires all new employees to be fully vaccinated against COVID-19 upon the start of their employment, unless they obtain prior approval for an accommodation for medical reasons or due to a sincerely held religious belief or are exempt from this requirement under applicable state or local law. Qualified candidates who are offered the opportunity to join C4 Therapeutics will be required to provide proof of vaccination during the onboarding process. 

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