The Position

The Clinical Quality Manager supports the Director of Clinical Quality Management & Training (DCQMT) with eTMF management, eTMF reviews, CRA Assessments, staff training, and quality and compliance management across Clinical Operations activities.

Responsibilities:

• Support DCQMT in eTMF management
• Lead CQMT quarterly eTMF reviews for study teams across programs
• Assist in the preparation and conduct of CRA Assessments
• Participate where needed in the review of unblinded trip review and provide unblinded support to study teams across programs
• Assist the DCQMT in the preparation and/or presentation of training documents/sessions/programs for Clinical Operations staff
• Assist DCQMT in the preparation and/or review of Clinical Operations documents (forms, templates, SOPs/WIs) or other internal documents
• Participate in the review of SOPs and WIs during annual reviews
• Assist DCQMT with new hire onboarding and training scheduling
• Assist DCQMT in the maintenance and review of training metrices
• Assist the DCQMT in maintaining the Vendor Issues Tracker
• Support Clinical Quality Assurance (CQA) in health authority inspection preparation activities
• Assist DCQMT and CQA with document preparation for any internal gap assessments or audits
• Assist the DCQMT in any additional quality initiatives

Requirements:

• Experience with eTMF systems and TMF reference model
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
• Proficient in MS Office (Word, Excel, and PowerPoint)
• Ability to work in a team or independently
• Effective interpersonal, written, and verbal communication skills
• Able to critically evaluate job tasks and the impact on overall study execution
• Strong problem-solving capabilities
• Able to effectively collaborate with study team members and other stakeholders
• Exceptional organizational skills with the ability to multi-task and prioritize
• Attention to detail
• Ability to work with distributed team members and outside vendors

Physical or Other Requirements:

• Standing, sitting, walking, climbing stairs, light lifting, computer operation
• Occasional travel in the US or overseas (<20%)

Qualifications:

• Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
• At least 7 years of experience in Clinical Operations or similar function
• At least 2 years of onsite monitoring/site management experience
• Prefer at least 2 years of experience working in Veeva Vault eTMF/Quality systems set-up and maintenance

Educational Requirements:

• 4-year college degree (preferred) otherwise, candidates with a combination of education and relevant experience will be considered