Study Start-Up Manager (Clinical Operations, Remote)

Job summary

The Study Start-Up Manager is responsible for planning and executing study start-up activities for assigned projects, ensuring compliance with regulatory requirements and internal processes. This role involves close collaboration with various stakeholders to meet project timelines and deliverables.

Qualifications

• Degree in a scientific or health discipline; advanced degree preferred with clinical trial experience and/or project management.
• Minimum of 5 years’ experience in clinical operations, particularly in project management or monitoring clinical trials.
• Fluent in English and local language as required.

Responsibilities

• Support the country SSU strategy in collaboration with team leads.
• Ensure timely completion of start-up activities from project allocation to site initiation.
• Collaborate with local IRBs/IECs and Health Authorities for submission processes.
• Prepare and finalize submission packages for regulatory bodies.
• Coordinate responses to deficiency letters with stakeholders.
• Maintain accuracy and quality of country TMF documents for inspection readiness.
• Implement efficient processes aligned with organizational strategy.
• Lead site selection and oversee local vendor performance.
• Prepare sites for “Green Light” and ensure documentation is complete.
• Lead local SSU team meetings and participate in global study team meetings.

Skills

• Budget Management
• Clinical Trials
• Negotiation Skills
• Process Improvement
• Project Planning
• Vendor Management
• Waterfall Model

Education

• Degree in scientific or health discipline required; advanced degree preferred.

Tools

• Familiarity with regulatory submission tools and TMF systems.