Note: The job is a remote job and is open to candidates in USA. JenaValve Technology, Inc. is seeking a Senior Manager, Clinical Compliance who will own the clinical compliance program for the company’s active clinical studies. This role involves managing the audit program, vendor qualifications, and ensuring quality oversight, while closely partnering with the Quality organization to maintain compliance and training within the department.
Responsibilities
- Develop and execute a risk-based audit program covering internal processes and investigational sites; author audit plans and reports, and lead inspection readiness activities including TMF health assessments and mock inspections; partner with Quality on audit scheduling, joint audit conduct, and preparation for regulatory agency inspections (FDA, EU Notified Body) and corporate quality audits
- Own CAPA and non-conformance management for the department; serve as the central accountability point for CAPA status, effectiveness checks, and closure, coordinating with functional owners across sub-teams; maintain alignment with Quality on CAPA creation, classification, and tracking to ensure consistency with enterprise quality system requirements
- Own the vendor qualification and ongoing quality oversight program for CROs, core labs, EDC vendors, and other clinical service providers; issue and track SCARs, evaluate corrective action responses, and escalate unresolved quality issues with contract implications to leadership
- Lead the Clinical Affairs procedure lifecycle, including authoring, reviewing, and approving SOPs and work instructions; coordinate the annual review cycle across sub-departments; maintain the controlled document management system in alignment with enterprise quality system standards, serving as the primary liaison to Quality on document control processes and procedure governance
- Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR); evaluate impact on operations and procedures and serve as the department’s internal GCP compliance subject matter expert
- Design and deliver the Clinical Affairs internal training program, including GCP onboarding, procedural updates, and audit corrective action training; maintain training matrices and completion records for all department personnel
- Directly manage and develop the Specialist, Clinical Compliance; provide day-to-day direction, performance feedback, and professional development support
- Support continuous process improvement and PMA/IDE activities as they relate to compliance, study conduct quality, and regulatory commitments; complete training for internal SOPs and maintain current regulatory knowledge
Skills
- 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
- 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
- Lead auditor competency (planning, execution, report writing, finding classification); strong analytical and root cause analysis skills
- Experience with CAPA programs and risk-based quality management (RBQM); strong analytical and root cause analysis skills
- Ability to influence without direct authority across clinical operations, data management, biostatistics, regulatory affairs, and medical affairs; proven cross-functional credibility
- Excellent written and oral communication skills; able to produce clear audit reports, procedure documents, and executive compliance summaries; proficient in Microsoft Office Suite and eTMF/document management systems
- Standard office environment requirements
- Travel up to 25%, primarily for investigational site audits, vendor audits, clinical meetings, and periodic home office visits
- Advanced degree preferred
- Lead auditor certification (ASQ, RAPS, or equivalent) preferred
- Cardiovascular or structural heart therapeutic area experience is a significant advantage
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