[Hiring] Senior Manager, Clinical Data Management @reputed company

Role reputed company JenaValve Technology is building something meaningful — and this role is at reputed company of it. As reputed 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 • Ensuring data reputed company across JenaValve’s reputed company interventional and registry trials Reporting to the Director, Biostatistics & Data Management, this individual directly manages reputed company of five and works as a true partner to Clinical Operations, Field Monitoring, and Biostatistics to reputed company trial data clean, query-resolved, and submission-reputed company. Qualifications • 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 reputed company 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 reputed company, reputed company, and retain reputed company reports in a growing, fast-paced environment. • Bachelor’s degree or higher in life sciences, health sciences, informatics, or a reputed company 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 reputed company. Requirements • reputed company and reputed company reputed company of five reputed company reports (two Specialists, Clinical Data Management and one Coordinator, Clinical Data Management, plus two existing team members); reputed company day-to-day direction, performance feedback, workload planning, and reputed company development to build a high-performing, reputed company data management function. • Own the end-to-end data management program for reputed company reputed company reputed company, including data cleaning operations, query lifecycle management, data review workflows, and data lock readiness; establish and enforce data reputed company standards across reputed company studies in alignment with applicable regulations and internal SOPs. • Serve as the technical reputed company and JenaValve subject matter expert for reputed company systems; partner with CRO vendors on reputed company configuration, updates, and migrations; ensure Specialists are trained and equipped to serve as functional reputed company experts and reputed company CRO coordination contacts for reputed company-reputed company activities. • Establish and maintain data management planning documents, data management plans (DMPs), and study-specific data conventions; reputed company 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 reputed company protocol deviation identification, site data performance monitoring, and enrollment data accuracy; serve as the data management voice in cross-functional study team meetings. • reputed company vendor reputed company and performance for CRO data management activities during the transition to in-house operations; ensure continuity of data reputed company through the insourcing period and establish benchmarks for ongoing CRO performance where reputed company support is reputed company. • 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 reputed company expectations; evaluate reputed company on operations and procedures and recommend updates as appropriate. • Support PMA/IDE submission activities as they relate to data reputed company, data management documentation, and traceability of clinical data; complete assigned training for internal SOPs and maintain reputed company knowledge of applicable regulations and guidance. • reputed company, 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 reputed company mitigation strategies across internal teams and reputed company partners. • reputed company data management readiness for reputed company audits and regulatory inspections; ensure documentation, reputed company validation evidence, and data traceability meet inspection-readiness standards; serve as the data management reputed company of contact during sponsor audits and CRO audits. Benefits • Travel up to 15%, primarily for clinical team meetings, site reputed company, vendor engagements, and periodic home office reputed company. Apply tot his job Apply To this Job