Manager of Non-Interventional Study Operations / Manageress of Non-Interventional Study Operations

Position: Manager, Non-Interventional Study Operations

Location: Germany
Posted On: 2026-04-27
Type: Contract
Remote: No
Salary Range: $0 Per Hour
Category: Clinical Operations

The Manager, Non-Interventional Study Operations plays a pivotal role in supporting the planning, implementation, and operational execution of non-interventional studies (NIS) in collaboration with Medical Affairs, Legal, Compliance, and external partners.

This 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 serves as the operational interface between Medical Affairs, Legal, Procurement, and CRO partners, facilitating the timely execution of real-world evidence studies.

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:
  • Site identification and feasibility
  • Site onboarding and documentation
  • 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 to ensure timely execution.
• Maintain a central tracker for site contracts, budgets, and study payments.

Vendor and CRO Coordination

• Act as the operational liaison with external partners, including:
  • Contract research organizations (CROs)
  • Data management vendors
  • 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 to ensure alignment on timelines and deliverables.
• Track study progress and escalate operational risks as necessary.

Study Tracking and Reporting

• Develop and maintain study trackers for:
  • Site onboarding status
  • Contracting progress
  • Budget tracking
  • Study milestones
• Provide regular updates to Medical Affairs leadership.

Qualifications

Education

• Bachelor’s or Master’s degree in Life Sciences, Public Health, or a related field.

Experience in:

• Clinical research
• Observational studies / NIS
• Study operations or project management

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

At Advanced Group, our commitment to diversity and inclusion within every facet of our organization is essential to fulfilling our mission while embodying our REAL values. We are dedicated to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

Advanced Group complies with federal and state disability laws and provides reasonable accommodations for applicants and candidates with disabilities.

Apply online using the form below. Only applications matching the job profile will be considered.