JENAVALVE TECHNOLOGY INC

Role Description 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 - 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. 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 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. Requirements - 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. Benefits - Travel up to 15%, primarily for clinical team meetings, site visits, vendor engagements, and periodic home office visits.

Role Description Reporting to the Senior Manager, Clinical Compliance, the Specialist, Clinical Compliance supports the operational execution of JenaValve’s clinical compliance program. Responsibilities span: - Audit logistics and documentation - CAPA and non-conformance tracking - Vendor qualification recordkeeping - SOP coordination - Training administration - Compliance metrics reporting The role requires independent judgment, strong organizational skills, and effective collaboration across Clinical Affairs sub-departments. Qualifications - 2+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred. - Bachelor’s degree or higher in life sciences, health sciences, or a related field required. - Working knowledge of ICH E6 GCP guidelines and FDA regulations applicable to medical device clinical trials; familiarity with ISO 14155 preferred. - Prior experience supporting clinical audit activities, document control, or compliance tracking is a significant advantage; cardiovascular or structural heart experience is an advantage. - Strong organizational skills and attention to detail; ability to manage multiple concurrent tracking responsibilities with accuracy in a fast-paced environment; excellent written and verbal communication skills. Requirements - Demonstrated ability to manage complex tracking systems across multiple work streams with high accuracy; strong Excel skills; familiarity with eTMF and document control systems. - Strong critical thinking and independent judgment; able to identify compliance gaps, prioritize follow-up, and escalate appropriately; ability to collaborate and influence effectively across a multi-functional organization. - Excellent written and oral communication skills; ability to produce clear compliance summaries, tracking reports, and procedure documents; proficient in Microsoft Office Suite; CTMS and EDC experience an advantage. Benefits - Standard office environment requirements. - Minimal travel, up to 10%.

Role Description Reporting to the Vice President, Clinical Affairs, the Senior Manager, Clinical Compliance owns the clinical compliance program for JenaValve’s active clinical studies. This includes: - Audit program (internal and investigational site) - Vendor qualification and quality oversight - Department procedure lifecycle - Regulatory intelligence - Internal training The role works in close partnership with the Quality organization to ensure alignment on quality systems, audit scheduling and conduct, and CAPA processes, serving as the primary compliance bridge between Clinical Affairs and Quality. This individual directly manages the Specialist, Clinical Compliance. Qualifications - 7+ years in clinical research, clinical operations, or clinical quality assurance; medical device experience strongly preferred. - Minimum 3 years dedicated GCP audit or clinical compliance experience; demonstrated experience as a lead auditor conducting both site and vendor/CRO audits required. - Bachelor’s degree or higher in life sciences, health sciences, or a related field required; advanced degree preferred. - Thorough knowledge of ICH E6(R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 812), and ISO 14155; demonstrated SOP authorship and procedure lifecycle management experience. - Prior people management experience; ability to lead and develop direct reports in a fast-paced, growing organization. - Cardiovascular or structural heart therapeutic area experience is a significant advantage. Requirements - Develop and execute a risk-based audit program covering internal processes and investigational sites. - Own CAPA and non-conformance management for the department. - Own the vendor qualification and ongoing quality oversight program for CROs, core labs, EDC vendors, and other clinical service providers. - Lead the Clinical Affairs procedure lifecycle, including authoring, reviewing, and approving SOPs and work instructions. - Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR). - Design and deliver the Clinical Affairs internal training program. - Directly manage and develop the Specialist, Clinical Compliance. - Support continuous process improvement and PMA/IDE activities as they relate to compliance. Benefits - Standard office environment requirements. - Travel up to 25%, primarily for investigational site audits, vendor audits, clinical meetings, and periodic home office visits.