Senior Manager, Clinical Compliance & Inspection Readiness

About the Role >>> Senior Manager Clinical Compliance & Inspection Readiness 

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. 

Your work will primarily encompass: 

• 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

And will also include: 

• 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

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• 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

Experience

• 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
• Experience in supporting Regulatory Authority (e.g. FDA, EMA, MHRA) GCP inspections is a plus
• 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
• TMF, EDC, CTMS working knowledge a plus

Attributes

• Ability to operate effectively in a fast-paced, ambiguous environment
• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Strong critical thinking skills with the ability to influence senior leadership and drive decision-making
• Exceptional attention to detail with a focus on accuracy and quality
• Continuous improvement mindset, with a focus on optimizing processes and driving efficiency

The base pay range for this position is expected to be $150,000-$170,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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