Senior Manager, Clinical Data Management

Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $175,000.00 - $175,000.00 SalaryJob 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. QualificationsRequired 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.