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Senior Manager – Clinical Operations
The O'Connor GroupAssociate Director of Clinical Operations leading clinical studies and providing operational leadership in a biotech company. Managing project delivery within budget, ensuring compliance and partnership across departments.
About the role
Key responsibilities & impact- Lead operational contact for clinical studies
- Provide strategic and operational leadership to the clinical operations team
- Ensure project milestones delivery on time, within budget, high quality, and in compliance
- Responsible for all operational aspects, strategic input, and progress of clinical trial
- Manage vendor activities to support clinical studies
- Oversee study timelines and budget planning
- Participate in country and site feasibility/selection process
- Ensure studies are 'inspection ready' at all times
- Create and foster strong strategic partnerships with colleagues
Requirements
What you’ll need- BA/BS
- 7 or more years of clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO), with a focus on clinical operations
- Developing and writing study protocols, study procedure manuals, informed consent forms, clinical study reports and other study plans/documents
- Leading outsourced studies across all functional areas (preclinical, stats, data management, and medical writing)
- Vendor oversight including operations and budget
- Ability to interpret data
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies
Benefits
Comp & perks- Professional office environment
- Occasional nights and weekends to meet company demands
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchclinical operationsstudy protocolsstudy procedure manualsinformed consent formsclinical study reportsvendor oversightdata interpretationbudget planningproject management
Soft Skills
strategic leadershipoperational leadershipcommunicationindependent judgmentpartnership buildingproblem solvingorganizational skillsteam collaborationtime managementadaptability
Certifications
BABS