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 collaboration with various stakeholders to meet timelines and deliverables effectively.

Qualifications

• A degree in a scientific or health discipline is required; an advanced degree with clinical trial experience and/or project management is preferred.
• Minimum of 5 years of experience in clinical operations, particularly in project management and monitoring clinical trials.
• Fluent in both written and spoken English, with proficiency in the local language as needed.

Responsibilities

• Support the country SSU strategy in collaboration with team leads and the global study team.
• Ensure timely completion of start-up activities from country allocation to site initiation.
• Collaborate with local IRBs/IECs and Health Authorities for necessary submissions.
• Prepare and finalize submission packages for IRB/IEC and Health Authorities.
• Manage responses to deficiency letters in coordination with stakeholders.
• Ensure the 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 as needed.
• Prepare sites for “Green Light” and ensure all documentation is complete.
• Lead local SSU team activities to achieve timelines and quality standards.

Skills

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

Education

• A degree in a scientific or health discipline is required; advanced degree preferred.

Tools

• Familiarity with clinical trial management systems and regulatory submission tools.