Senior Medical Affairs Operations Manager
Crinetics Pharmaceuticals
June 27, 2026
Remote friendly (United States)
United States
$147,000 - $184,000 USD yearly
Medical Affairs
Position Summary
The Senior Medical Affairs Operations Manager is responsible for managing execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies, and post-trial access programs. Oversees review, monitoring, and adherence to clinical protocols; owns key projects; works independently; interacts with cross-functional study team and may supervise more junior managers/assistants.
Essential Job Functions and Responsibilities
- Oversee clinical affairs programs across the drug development process, including post-trial access programs and continued investigational product provision per regional regulations.
- Provide operational/strategic input for expanded access planning and study documents (synopses, protocols, ICFs, CRFs, completion guidelines, execution plans, data review plans, database edit specifications, CSR development, etc.).
- Coordinate and lead study team meetings; provide progress updates (timelines, budget, milestones).
- Develop subject recruitment/retention strategy.
- Oversee TMF setup, quality review, and final reconciliation; review site regulatory documents/packages and obtain site insurance; supervise related activities.
- Develop training materials for program team, sites, and vendors.
- Share information proactively via standardized reports/mechanisms.
- Ensure compliance with ICH/GCP and applicable regulations.
- Oversee preparation of RFPs and bid templates for CRO/vendor selection (and/or collaborate/supervise).
- Collaborate with counsel to negotiate/draft contracts and agreements.
- Liaise with Regulatory Affairs to maintain SOPs and ensure site/CRO/vendor audits.
- Perform study risk management and implement mitigations.
- Identify issues and implement solutions/corrective actions.
- Create realistic plans with goals, milestones, responsibilities, and results.
- Make timely, data-driven decisions.
Required Qualifications
- Bachelor’s degree (preferably scientific) or equivalent education/experience.
- 8+ years clinical operations experience managing clinical trials (preferably CRO/small biotech); 5+ years in a supervisory role. Study management preferred.
- Proficiency with Microsoft Office, electronic TMF systems, IRT, and EDC.
- Strong understanding of drug development; ability to make decisions to move projects forward.
- Effective verbal/written communication.
- Experience managing site-to-data processing/review/resolution flow.
- Ability to analyze and generate reports.
- Understanding of FDA regulatory requirements (GCP, CFRs, etc.).
- Ability to manage multiple tasks and meet deadlines; experience with study initiation.
Preferred
- Experience in rare disease and/or oncology.
Benefits (explicitly stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match.
- Medical/dental/vision and basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
Travel
- Up to 10%.
The Senior Medical Affairs Operations Manager is responsible for managing execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies, and post-trial access programs. Oversees review, monitoring, and adherence to clinical protocols; owns key projects; works independently; interacts with cross-functional study team and may supervise more junior managers/assistants.
Essential Job Functions and Responsibilities
- Oversee clinical affairs programs across the drug development process, including post-trial access programs and continued investigational product provision per regional regulations.
- Provide operational/strategic input for expanded access planning and study documents (synopses, protocols, ICFs, CRFs, completion guidelines, execution plans, data review plans, database edit specifications, CSR development, etc.).
- Coordinate and lead study team meetings; provide progress updates (timelines, budget, milestones).
- Develop subject recruitment/retention strategy.
- Oversee TMF setup, quality review, and final reconciliation; review site regulatory documents/packages and obtain site insurance; supervise related activities.
- Develop training materials for program team, sites, and vendors.
- Share information proactively via standardized reports/mechanisms.
- Ensure compliance with ICH/GCP and applicable regulations.
- Oversee preparation of RFPs and bid templates for CRO/vendor selection (and/or collaborate/supervise).
- Collaborate with counsel to negotiate/draft contracts and agreements.
- Liaise with Regulatory Affairs to maintain SOPs and ensure site/CRO/vendor audits.
- Perform study risk management and implement mitigations.
- Identify issues and implement solutions/corrective actions.
- Create realistic plans with goals, milestones, responsibilities, and results.
- Make timely, data-driven decisions.
Required Qualifications
- Bachelor’s degree (preferably scientific) or equivalent education/experience.
- 8+ years clinical operations experience managing clinical trials (preferably CRO/small biotech); 5+ years in a supervisory role. Study management preferred.
- Proficiency with Microsoft Office, electronic TMF systems, IRT, and EDC.
- Strong understanding of drug development; ability to make decisions to move projects forward.
- Effective verbal/written communication.
- Experience managing site-to-data processing/review/resolution flow.
- Ability to analyze and generate reports.
- Understanding of FDA regulatory requirements (GCP, CFRs, etc.).
- Ability to manage multiple tasks and meet deadlines; experience with study initiation.
Preferred
- Experience in rare disease and/or oncology.
Benefits (explicitly stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match.
- Medical/dental/vision and basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
Travel
- Up to 10%.