Senior Clinical Compliance Specialist
Hologic
San Diego, CA
Senior Clinical Compliance Specialist
Position Type:
Full time
Responsibilities:
• Maintains and contributes to a Clinical Quality Management System to ensure San Diego Clinical Affairs (CA) activities are carried out in accordance with current applicable company policies and procedures, and laws, regulations, and guidelines
• Researches and summarizes knowledge and information on current regulations, guidance, best practices relevant to Hologic Diagnostic products and clinical studies; publishes and presents assessments and findings to stakeholders
• Hosts internal Quality Assurance (QA) audits of CA, and supports audits and inspections of Hologic conducted by external regulatory entities (e.g., US FDA Bioresearch Monitoring (BIMO), Notified Bodies (NB))
• Conducts audits of clinical studies at external sites and in-house
• Conducts review and change control of CA documents and procedures in the Quality System Manual and in department-specific libraries
• Oversees and manages CA department and corporate policy and procedure training requirements
• Supports CA personnel on use of corporate and department systems used for creating, editing and storing documents and information; curates documents and information to ensure relevancy and contemporaneousness
• Provides support to clinical study projects and functions as needed
• Keep current in IVD Clinical, Regulatory and Quality trends and intelligence by conducting relevant research online and by attending forums. Write summaries to provide relevant information to stakeholders as requested. Share and curate relevant information on CA Intranet
• Support CA as a subject matter expert (SME) in audits of CA by meeting with auditors and providing documentation and information
• Conduct periodic audits of Trial Master Files (TMFs) in-house; audit external clinical study sites as assigned by study management. Write detailed reports and communicate findings
• Conduct change control activities for all Clinical Affairs documents in Agile Product Lifecycle Management (PLM) environment, and in the SharePoint Clinical Documents library
• Champion department and corporate training for Clinical Affairs; ensure department and corporate training requirements are kept current; identify gaps. Act as department Superuser of corporate training system
Qualifications:
• Strong knowledge of US and EU regulations relevant to Medical Device and IVD clinical trials and Quality Systems, including GCP
• Excellent technical writing and presentation skills
• Advanced user of Microsoft Office (Word, Excel, PowerPoint) and Visio a plus; experience using Microsoft SharePoint a plus
• Education
• Minimum BA/BS degree in Life Sciences or equivalent qualification
• Advanced degree or professional certification in Clinical, Regulatory and/or Quality (e.g., RAC, CCRA/CCRP, RQAP-GCP) is highly preferred
Education and Experience
• 8-10 years of progressive experience in clinical research within a regulated industrial setting. Experience in an IVD environment is highly preferred
• Reading, interpreting, and summarizing regulations, guidelines, best practices relevant to clinical research
• Writing and editing summary documents, procedures, protocols, or other technical documents, and presenting to stakeholders at all levels
• Hosting audits and conducting in-house and external site audits. GCP audit experience preferred
• Experience auditing documents and processes
• Use of change management concepts and software, and Microsoft Office tools
Application Information & Contact (How to Apply)
Please apply here.
Learn more about Hologic here.