Regulatory & Start-Up Manager (Clinical Operations, Flexible/Remote)

Job summary

This role involves leading complex clinical trial start-up activities across global or multi-regional studies, focusing on site activation, regulatory strategy, and ongoing site maintenance for clinical research programs.

Qualifications

• Bachelor’s degree in Life Sciences or a related field
• 3–5 years of relevant experience, with up to 7+ years preferred in a scientific or clinical research environment
• Experience with international clinical trials
• In-depth knowledge of the clinical trial lifecycle and regulatory requirements

Responsibilities

• Direct and manage site activation and regulatory activities for assigned studies
• Develop and maintain Regulatory & Start-Up Management Plans
• Define and implement regulatory strategy, including submission requirements
• Review, negotiate, and track regulatory and contractual documentation
• Monitor site performance metrics for compliance with SOPs, GCP, ICH, and regulations
• Collaborate across regions for multi-regional and multi-protocol programs
• Provide creative solutions to operational challenges
• Mentor and coach team members
• Build and maintain relationships with sponsors and investigative sites
• Support monthly study budget planning and reviews

Skills

• Strong stakeholder management and negotiation skills
• Excellent communication and interpersonal abilities
• Strong organizational, planning, and problem-solving skills
• Confidence using clinical systems and technology (e.g., CTMS)

Education

• Bachelor’s degree in Life Sciences or a related field

Tools

• Clinical Trial Management Systems (CTMS) and project tracking tools