Senior Manager, Clinical Compliance & Inspection Readiness
About The Position
As the Senior Manager, Clinical Compliance & Inspection Readiness reporting to the Senior Director, Clinical Compliance & Documentation you will be responsible for supporting the advancement of Olema’s clinical studies by ensuring clinical quality, GCP adherence, procedural development / SOP management, process improvements, risk management, and training. This role will collaborate cross-functionally to provide solution-orientated compliance guidance, drive best practices, create tools, implement lessons learned, and improve future capabilities that overall, enhance the effectiveness of compliant clinical study execution and “Real Time” Inspection Readiness. In addition, this person will support inspection readiness activities by completing study performance health checks through Key Performance Indicators (KPIs), supporting storyboard creation, and participating in regulatory inspection preparation activities. This role can be based out of our Boston, MA or San Francisco, CA offices and will require 10-15% travel.
Requirements
- Bachelor's Degree
- Knowledge and preferably experience in global clinical trial execution, drug development process, and operations
- Familiarity with root cause analysis and CAPA development
- Development and Tracking of KPIs
- Minimum of 7+ years of experience in the pharmaceutical/biotech industry (sponsor and/or CRO)
- 5+ years of compliance, GCP Function, or clinical project leadership
- Ability to work, lead, coordinate, and project manage activities to drive change within the organization
- Ability to manage multiple projects simultaneously, prioritize workload for teams and function in fast-paced environment
Nice To Haves
- Experience in supporting Regulatory Authority (e.g. FDA, EMA, MHRA) GCP inspections is a plus
- TMF, EDC, CTMS working knowledge a plus
Responsibilities
- Building and maintaining fit-for-purpose clinical compliance processes aligned with ICH-GCP and applicable global regulations
- Partnering with Clinical Operations and study execution teams to embed quality-by-design principles throughout study lifecycle
- Providing hands-on compliance guidance, identifying compliance risks, and driving proactive mitigation strategies
- Responsible for ongoing identification of opportunities to further develop and improve GCP Inspection and Clinical Compliance Management strategy, processes, tools and templates
- Assisting with optimization of the Standard Operating Procedures (SOPs), processes, training, and rollout across the Clinical teams
- Supporting Study Oversight, Risk Management, Vendor Oversight, Monitoring Oversight, KPI Tracking, GDPR, Trial Disclosure and TMF Health check activities
- Leading root cause analysis and the development of Quality Events / CAPAs, ensuring pragmatic / scalable solutions and timely remediation
- Assisting Clinical Quality as needed with Site and CRO inspection preparation activities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
