Scripps Research · 14 hours ago
Sr. Manager, Clinical Data Management
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$152K/yr - $175K/yr
15+ years expScripps Research is a leading nonprofit translational research institute focused on innovative medicine development. The Senior Manager of Clinical Data Management will provide leadership and oversight for data management activities in clinical studies, ensuring high standards of quality and compliance throughout the process.
BiotechnologyHealthcarePharmaceuticalBiopharmaMedical
Responsibilities
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
Qualification
Required
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
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
Benefits
Employer Contributed Retirement Plan – Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)
Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more
Access to Flexible Spending Accounts (Medical/Dependent Care)
Competitive vacation and sick leave policies
Free, on-site parking
Company
Scripps Research
Scripps Research is a leader in the discovery and application of biomedical breakthroughs that improve human health.
1001-5000 employees
H1B Sponsorship
Scripps Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$71.2MKey Investors
National Institute of Diabetes and Digestive and Kidney DiseasesThe Conrad Prebys FoundationNational Institute of Allergy and Infectious Diseases
2025-10-08Grant· $3.2M
2025-05-28Grant· $1M
2022-05-18Grant· $67M
Leadership Team
Ed Ramos
Director of Digital Clinical Trials, Co-founder Digital Trials Center
Caroline M.
Chief Operating Officer
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