Sr. Central Risk Manager, RBQM (North America)
Skills
About the role
This is a remote, North America-based senior role for a Central Risk Manager specializing in Risk-Based Quality Management for clinical trials at a biopharmaceutical solutions company. It suits an experienced clinical research professional who can lead central monitoring, risk assessment and RBQM process ownership across study teams. You'll guide study teams on risk management, develop central monitoring tools and analytics, and serve as a subject matter expert and process owner for RBQM.
What you’ll do
- Provide guidance, training and support on RBQM in clinical trials, ensuring adherence to ICH GCPs and regulatory requirements
- Advise study teams on risk management activities and author the Central Monitoring Plan
- Contribute to identifying Quality Tolerance Limits, risks, thresholds and mitigations
- Facilitate cross-functional risk review meetings and risk signal interpretation and triage
- Oversee timely resolution of risk signals and issues identified through central monitoring
- Support development of data analytical tools used for central monitoring
- Map, manage and design RBQM dataflows across clinical and operational databases
- Support inspection-readiness and participate in audits and regulatory inspections
- Serve as a subject matter expert and process owner for assigned RBQM areas
- Manage RACT libraries and drive consistency across programs and therapeutic areas
What they’re looking for
- 8-10 years in clinical research with 3 years of RBQM or central monitoring experience
- Expertise in RBQM strategies, processes, tools and implementation
- Expertise in data analytic software, analytical data visualization tools and MS Excel
- Proficiency in R programming language
- Technical understanding of statistical analysis techniques in central monitoring
- Strong verbal, written and presentation communication skills, fluent in English
- Ability to lead without authority and influence stakeholders across functions, cultures and geographies
- Thorough knowledge of national and global regulations governing clinical research
- Ability to travel as needed
What’s on offer
- Remote, North America-based role
- Health benefits including Medical, Dental and Vision
- Company match 401k
- Eligibility for Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on performance
- Flexible paid time off and sick time
- Possible company car or car allowance
Questions about this role
Is this role remote?
Yes, it's a North America-based remote role.
How many years of experience do I need?
8-10 years in clinical research, including 3 years of RBQM or central monitoring experience.
Is this a currently open position?
The posting states it is intended for a possible upcoming opportunity and applicants are added to a talent pipeline.
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