Sr. Manager, Clinical Data Management

ABOUT US
Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs’ drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team.

position TITLE: Sr. Manager, Clinical Data Management

POSITION SUMMARY:

The Senior Data Manager will provide leadership and operational oversight for end-to-end data management activities across assigned clinical studies. The incumbent will ensure data are collected, processed, and delivered to the highest standards of quality, integrity, and regulatory compliance from study start-up through database lock. This position will provide input into Biometrics strategy and implement department initiatives. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data.

RESPONSIBILITIE & DUTIES:

• Establish functional strategic initiatives and support development of cross-departmental standard procedures.
• Review protocols from a CDM perspective and provide functional-expert feedback.
• Identify SOPs for Data Management and develop SOPs, Working Instructions, and templates with cross-functional team.
• Develop and maintain study Data Management Plans (DMPs), eCRF specifications, edit-check programming specifications, data review and reconciliation plans, and data transfer specifications.
• Lead EDC design, build, validation, and user acceptance testing; manage mid-study updates and version control.
• Oversee data review, query management, medical coding (MedDRA, WHO Drug), and reconciliation of external data (eCOA/ePRO, central labs, PK/PD, imaging, IRT, safety/SAE).
• Implement and enforce CDISC/SDTM standards and controlled terminology.
• Provide day-to-day oversight of CROs and EDC vendors; chair data review meetings; track KPIs and resolve issues.
• Drive interim analyses and final database lock; ensure inspection-ready documentation and timely TMF contributions.
• Ensure compliance with ICH-GCP, 21 CFR Part 11, GDPR/HIPAA, and internal SOPs.
• Contribute to process improvement, CRF libraries, edit-check catalogs, and data quality dashboards.
• Oversee project plans and timelines for outsourced studies and monitor progress against key milestones.
• Serve as primary data management contact for both internal teams and external vendors.
• Ensure appropriate TMF documentation of data management deliverables.
• Proactively identify and mitigate risks to data quality, compliance, and delivery timelines.
• Support audit and inspection readiness and participate in CDM process improvements.
• Promote constructive, effective relations while collaborating with cross-functional team members such as Clinical Operations, Biostatistics, Medical, Drug Safety, and other teams.

POSITION REQUIREMENTS:

• Bachelor’s degree in Life Sciences, Data Science, or related field; Master’s degree preferred.
• 15+ years of clinical data management experience in biopharma or CRO, including 10+ years as study lead and/or vendor management oversight lead.
• Proficiency with at least one major EDC platform (e.g., Medidata Rave, Veeva CDMS, Oracle Inform, Medrio).
• Experience with IRT or RTSM and EDC integration.
• Demonstrated experience with CDASH, CDISC/SDTM, medical coding, external data integrations, and SAE reconciliation.
• Thorough knowledge of ICH-GCP and 21 CFR Part 11 and their Application to data systems and processes.
• Familiarity with emerging clinical data technologies such as eSource, DCTs, and real-time data visualization platforms.
• Strong experience managing CDM activities through CROs or external vendors.
• Familiarity with in-house data management model.
• Experience with eTMF systems and their role in study documentation.
• Excellent technical writing, documentation, project management, and cross-functional communication skills.
• Ability to thrive in a fast-paced, resource-conscious, and collaborative environment.

PREFERRED QUALIFICAIONS:

• Experience in IBD, immunology, oncology, and/or cell/gene therapy studies.
• Familiarity with ADaM deliverables and DSMB/IA data packages.
• Working knowledge of SQL or R/Python for listings, quality checks, and metrics.
• Managerial and oversight experience with junior level data managers.
• Experience in identifying efficiencies and implementing a blended-model of outsourcing specific data management tasks while also overseeing and performing portions of data management tasks in-house.

PHYSICAL REQUIREMENTS: