Computer System Validation Remote Jobs in Lake Forest, CA

Job Title: Senior Manager, Clinical Data Management

Role Level: People Manager

Supervisor/Manager Title: Director, Biostatistics & Data Management

Job Location & Environment: Remote – Home Office

Job Description Summary: JenaValve Technology is building something meaningful — and this role is at the center of it. As the company brings clinical data management fully in-house for the first time, the Senior Manager, Clinical Data Management will own that function from the ground up: building team capability, establishing process infrastructure, and ensuring data integrity across JenaValve’s active interventional and registry trials. Reporting to the Director, Biostatistics & Data Management, this individual directly manages a team of five and works as a true partner to Clinical Operations, Field Monitoring, and Biostatistics to keep trial data clean, query-resolved, and submission-ready.

Job Responsibilities:

• Lead and develop a team of five direct reports (two Specialists, Clinical Data Management and one Coordinator, Clinical Data Management, plus two existing team members); provide day-to-day direction, performance feedback, workload planning, and professional development to build a high-performing, scalable data management function.
• Own the end-to-end data management program for all active clinical trials, including data cleaning operations, query lifecycle management, data review workflows, and data lock readiness; establish and enforce data quality standards across all studies in alignment with applicable regulations and internal SOPs.
• Serve as the technical lead and JenaValve subject matter expert for EDC systems; partner with CRO vendors on EDC configuration, updates, and migrations; ensure Specialists are trained and equipped to serve as functional EDC experts and primary CRO coordination contacts for system-related activities.
• Establish and maintain data management planning documents, data management plans (DMPs), and study-specific data conventions; oversee authorship and lifecycle management of data management SOPs and work instructions in coordination with Clinical Compliance.
• Build and maintain a strong dotted-line partnership with Clinical Operations, CRAs, and Field Monitoring teams to ensure prompt protocol deviation identification, site data performance monitoring, and enrollment data accuracy; serve as the data management voice in cross-functional study team meetings.
• Oversee vendor quality and performance for CRO data management activities during the transition to in-house operations; ensure continuity of data quality through the insourcing period and establish benchmarks for ongoing CRO performance where external support is retained.
• Partner with Biostatistics on data standards (CDISC/CDASH), database lock procedures, and submission dataset readiness; ensure alignment between data management outputs and statistical analysis requirements.
• Monitor regulatory developments relevant to clinical data management, including FDA guidance on electronic data capture, 21 CFR Part 11, and ICH E6(R3) data integrity expectations; evaluate impact on operations and procedures and recommend updates as appropriate.
• Support PMA/IDE submission activities as they relate to data quality, data management documentation, and traceability of clinical data; complete assigned training for internal SOPs and maintain current knowledge of applicable regulations and guidance.
• Develop, manage, and communicate data management timelines for study-level deliverables (e.g., interim analyses, data cleaning milestones, database locks, submission readiness); proactively identify risks to timelines and drive mitigation strategies across internal teams and external partners.
• Lead data management readiness for internal and external audits and regulatory inspections; ensure documentation, system validation evidence, and data traceability meet inspection-readiness standards; serve as the data management point of contact during sponsor audits and CRO audits.

Required Education and Experience:

• 7+ years of clinical data management experience in the pharmaceutical, biotechnology, or medical device industry; medical device or cardiovascular/structural heart experience strongly preferred.
• Minimum 3 years in a lead or senior data management role with demonstrated ownership of study-level data cleaning, query management, and database lock activities.
• Prior people management experience; ability to lead, develop, and retain direct reports in a growing, fast-paced environment.
• Bachelor’s degree or higher in life sciences, health sciences, informatics, or a related field required; advanced degree preferred.
• Thorough knowledge of ICH E6(R3), 21 CFR Parts 11 and 812, and CDISC/CDASH data standards; demonstrated experience authoring or overseeing data management plans and SOPs.
• Experience managing or transitioning data management functions in-house from a CRO is a significant advantage.

Skills and Abilities Required for This Job:

• Deep proficiency in EDC platforms (Medidata Rave, Oracle InForm, REDCap, or equivalent); experience overseeing EDC build review, UAT coordination, and system migration in partnership with CRO or vendor teams.
• Strong analytical and problem-solving skills; ability to identify data quality trends, escalate risks, and implement corrective strategies across multiple concurrent studies.
• Demonstrated ability to build collaborative partnerships with Clinical Operations, CRAs, Field Monitoring, and Biostatistics; proven cross-functional credibility in a clinical trial environment.
• Excellent written and oral communication skills; able to produce clear data management documentation, status summaries, and executive-level updates; proficient in Microsoft Office Suite and eTMF/document management systems.

Physical Requirements:

• Travel up to 15%, primarily for clinical team meetings, site visits, vendor engagements, and periodic home office visits.