Senior Manager, Clinical Data Management

3 weeks ago

Watertown, Massachusetts, United States C4 Therapeutics Inc Full time
About C4 Therapeutics

C4 Therapeutics 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. Our team is passionate about developing innovative treatments for difficult-to-treat diseases, and we're looking for a skilled Senior Manager, Clinical Data Management to join our team.

Job Summary

The Senior Manager, Clinical Data Management will be responsible for leading and overseeing data management tasks from study start-up through database lock and reporting for clinical trials. You will work collaboratively with multiple cross-functional groups to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are following standard operating procedures and regulatory agency guidelines.

Your Role
  • Provide oversight and participate in trial or program level CDM activities.
  • Provide DM operational leadership for the direction, planning, execution, collection, and handling of all clinical data to the highest quality standard while ensuring compliance with industry-established standards and C4 Therapeutics, Inc. reporting requirements.
  • Participate in project timelines and monitor progress of data management activities.
  • Perform and/or oversee study setup and initiation procedures, such as eCRF design, database design, edit check design/review, DMP, annotated eCRFs, etc. for review and approval.
  • Be a strong technical resource relative to Medidata Rave (EDC)/Veeva (EDC) and CDM supportive tools, programming and reporting environments.
  • Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedures.
  • Perform user acceptance testing (UAT) on database applications and data transfers.
  • Create, edit, and maintain study documentation (i.e. DMP, FDRP, eCRF Completion Guidelines, Data Transfer Agreements, etc.) throughout study conduct and follow through with approvals.
  • Review, analyze, and validate clinical trial data throughout the study life cycle to ensure data consistency, integrity, and accuracy based on project specific guidelines.
  • Query data inconsistencies within the clinical database along with managing CRO vendor.
  • Assist Medical Monitor with MedDRA and WHO drug listing reviews on clinical data and coordinate with CRO vendor for corrections if necessary.
  • Generate and review reports and listings to maintain data integrity and reporting.
  • Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers.
  • Act as the CDM liaison/lead to communicate study status, timeline updates, scope change with internal project management and departmental leadership.
  • Manage and/or liaise with 3rd party vendors (CROs, Labs, Imaging, ECG etc.) specifically related to data collection, review/cleaning and analysis, and communicate project timelines.
  • Perform external data reconciliation (PK, Biomarker, AE/SAE, etc.) and assist in developing reports and computer programs to assist in data review process and provide operational metrics.
  • Participate in the development of CDM related policies, SOPs, work instructions, standards, and clinical development process improvements.
  • Perform other assigned tasks related to data management as needed.
  • Perform as part of a project team to facilitate effective and efficient execution of trial activities.
Your Background
  • 10+ years industry experience in Clinical Data Management plus Bachelor's degree in Biology, Pharmacology, Computer Science, Mathematics, Statistics or related field or an equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities to perform the above-described responsibilities.
  • CCDM certification a plus.
  • Demonstrated experience in the review of clinical data analysis, tables/listings/figures and patient profiles for data consistency and accuracy.
  • Familiarity and working knowledge of industry practices and standards GCDMP, CDISC, SDTM, CDASH, 21 CFR Part 11, GDPR.
  • Experience with various types of electronic data management tools (EDC, ePRO, eSource, IWRS, reporting tools).
  • Experience with the following systems: Veeva CDMS and Medidata Rave EDC preferred, JReview, Spotfire.
  • Working knowledge of MedDRA and Who-Drug coding dictionaries.
  • Oncology experience required.
Capabilities
  • Collaborate and communicate in an open and clear manner, listening effectively and inviting response and discussion with internal partners and external service providers.
  • Anticipate and proactively resolve issues when and where possible, applying logical methodology.
  • Ability to communicate data management standards, developments, and challenges in an accurate, concise, and organized manner to both internal and external customers.
  • Comfortable in a fast-paced, results-driven, highly accountable environment with large potential impact.
C4 Therapeutics is an Equal Opportunity Employer.

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