Position Summary
The Manager, Non-Interventional Study Operations supports the planning, implementation, and operational execution of non-interventional studies (NIS) in collaboration with Medical Affairs, Legal, Compliance, and external partners.

The role ensures efficient site onboarding, contracting, and operational management of dermatology study sites (approximately 100 centers) while maintaining compliance with internal SOPs, regulatory requirements, and pharmacovigilance standards.
This position acts as the operational interface between Medical Affairs, Legal, Procurement, CRO partners, to enable timely execution of real-world evidence studies.
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Key Responsibilities
Study Set-Up and Implementation
•         Support Medical Affairs and CRO in the operational planning and launch of non-interventional studies.
•         Coordinate study start-up activities including:
o         Site identification and feasibility
o         Site onboarding and documentation
o         Study documentation management
Contracting and Site Management
•         Lead and coordinate the contracting process for approximately 100 dermatology sites.
•         Collaborate with Legal, Procurement, and Finance to prepare and execute site agreements.
•         Track contracting status and ensure timely execution.
•         Maintain a central tracker for site contracts, budgets, and study payments.
Vendor and CRO Coordination
•         Act as operational liaison with external partners including:
o         Contract research organizations (CROs)
o         Data management vendors
o         Study support providers
•         Monitor vendor deliverables, timelines, and operational milestones.
Cross-Functional Coordination
•         Serve as the operational coordinator between Medical Affairs, Legal, Compliance, Procurement, and external vendors.
•         Facilitate internal meetings and ensure alignment on timelines and deliverables.
•         Track study progress and escalate operational risks where necessary.
Study Tracking and Reporting
•         Develop and maintain study trackers including:
o         Site onboarding status
o         Contracting progress
o         Budget tracking
o         Study milestones
•         Provide regular updates to Medical Affairs leadership.
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Qualifications
Education
•         Bachelor’s or Master’s degree in Life Sciences, Public Health, or related field.
Experience in:
o         Clinical research
o         Observational studies / NIS
o         Study operations or project management

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

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Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].