Specialist, Clinical Compliance

Job Title: Specialist, Clinical Compliance

Role Level: Individual Contributor (IC)

Supervisor/Manager Title: Senior Manager, Clinical Compliance

Job Location & Environment: Remote – Home Office

Job Description Summary: 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, and compliance metrics reporting. The role works in partnership with the Quality organization on quality system alignment and supports activities that bridge Clinical Affairs and Quality. The role requires independent judgment, strong organizational skills, and effective collaboration across Clinical Affairs sub-departments.

Job Responsibilities:

• Support audit planning and execution for internal and investigational site audits; coordinate logistics, prepare audit packages, manage document requests, and maintain audit files and correspondence in the eTMF; track findings and response deadlines, maintain the audit log, and escalate aging items to the Senior Manager.
• Support inspection readiness activities including TMF organization and document gap assessments; assist in maintaining an audit-ready TMF across active studies.
• Enter, track, and monitor CAPAs, non-conformances, and audit corrective actions; follow up with functional owners on action item status, maintain closure documentation, and prepare periodic status reports for the Senior Manager; support alignment with Quality on CAPA records and enterprise quality system tracking requirements.
• Support vendor qualification activities for CROs, core labs, and other clinical service providers; manage qualification questionnaires, maintain vendor files and re-qualification schedules, and track SCAR issuance and resolution.
• Coordinate the annual SOP and procedure review cycle across Clinical Affairs sub-departments; maintain the procedure calendar and tracking log, facilitate approval routing and version control, and assist in drafting and formatting procedure documents as directed; support document control workflows in alignment with Quality system standards.
• Administer training assignments, completions, and records across Clinical Affairs; maintain training matrices and coordinate scheduling for department training sessions, including GCP onboarding for new personnel.
• Maintain compliance metrics dashboards; compile data and prepare periodic reports summarizing audit status, CAPA progress, training completion, and vendor quality activity; assist in monitoring regulatory and GCP guidance updates as directed.
• Support continuous process improvement and other clinical affairs deliverables as needed; complete training for internal SOPs and maintain current regulatory knowledge.

Required Education and Experience:

• 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.

Skills and Abilities Required for This Job:

• 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.

Physical Requirements:

• Standard office environment requirements.
• Minimal travel, up to 10%.