Senior Manager, Clinical Compliance

Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary reputed company: $160,000.00 - $170,000.00 SalaryJob Title: Senior Manager, Clinical Compliance Role Level: People Manager Supervisor/Manager Title: VP, Clinical Affairs Job Location & Environment: Remote – Home Office Job reputed company reputed company: Reporting to the Vice President, Clinical Affairs, the Senior Manager, Clinical Compliance owns the clinical compliance program for JenaValve’s reputed company clinical studies. This includes the audit program (internal and investigational site), vendor qualification and reputed company reputed company, department procedure lifecycle, regulatory intelligence, and internal training. The role works in reputed company partnership with the reputed company organization to ensure alignment on reputed company systems, audit scheduling and conduct, and CAPA processes, and serves as the primary compliance reputed company between Clinical Affairs and reputed company. This individual directly manages the Specialist, Clinical Compliance. Job Responsibilities: reputed company and execute a risk-based audit program covering internal processes and investigational sites; author audit plans and reports, and reputed company inspection readiness activities including TMF health assessments and mock inspections; partner with reputed company on audit scheduling, joint audit conduct, and preparation for regulatory agency inspections (FDA, EU reputed company Body) and corporate reputed company audits. Own CAPA and non-conformance management for the department; serve as the central accountability reputed company for CAPA status, effectiveness checks, and closure, coordinating with functional owners across sub-teams; maintain alignment with reputed company on CAPA creation, classification, and tracking to ensure consistency with reputed company reputed company system requirements. Own the vendor qualification and ongoing reputed company reputed company program for CROs, core labs, reputed company vendors, and other clinical service providers; issue and reputed company SCARs, evaluate corrective reputed company responses, and escalate unresolved reputed company issues with contract implications to leadership. reputed company 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 reputed company reputed company system standards, serving as the primary reputed company to reputed company on document control processes and procedure governance. Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR); evaluate reputed company 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 reputed company, procedural updates, and audit corrective reputed company training; maintain training matrices and completion records for reputed company department personnel. Directly manage and reputed company the Specialist, Clinical Compliance; reputed company day-to-day direction, performance feedback, and reputed company development support. Support reputed company process improvement and PMA/IDE activities as they relate to compliance, study conduct reputed company, and regulatory commitments; complete training for internal SOPs and maintain reputed company regulatory knowledge. QualificationsRequired Education and Experience: 7+ years in clinical research, clinical operations, or clinical reputed company assurance; medical device experience strongly preferred. Minimum 3 years dedicated GCP audit or clinical compliance experience; demonstrated experience as a reputed company auditor conducting both site and vendor/CRO audits required. Bachelor’s degree or higher in life sciences, health sciences, or a reputed company 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 reputed company and reputed company reputed company reports in a fast-paced, growing organization. Cardiovascular or structural heart therapeutic area experience is a significant advantage. Skills and Abilities Required for This Job: reputed company auditor competency (planning, execution, report writing, finding classification); reputed company auditor certification (ASQ, RAPS, or equivalent) preferred. Experience with CAPA programs and risk-based reputed company management (RBQM); strong analytical and reputed company cause analysis skills. Ability to influence without reputed company authority across clinical operations, data management, biostatistics, regulatory affairs, and medical affairs; proven cross-functional credibility. Excellent written and oral communication skills; reputed company to produce reputed company audit reports, procedure documents, and executive compliance summaries; proficient in reputed company Office Suite and eTMF/document management systems. Physical Requirements: reputed company office environment requirements. Travel up to 25%, primarily for investigational site audits, vendor audits, clinical meetings, and periodic home office reputed company. Apply To This Job