Global Study Start-Up Submissions Lead

Medspace; Cincinnati (OH); On-site; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Health benefits

On-site with occasional WFH

Job summary

Medpace is seeking a Regulatory Submissions (Study Start-up) Manager for our UK Clinical Operations team. This office-based role focuses on leading global start-up activities, ensuring quality regulatory documents, and timely submissions.

You will coordinate informed consent processes, review regulations, and support audits and bid defenses. The ideal candidate has extensive CRO experience, European CTAs knowledge, and strong leadership and communication skills to drive cross-functional

Qualifications

• Extensive experience in clinical research, preferably with a CRO, including project management exposure.
• Knowledge and experience of Clinical Trial Applications within Europe (CTA/SMTA).
• Strong oral and written communication skills, able to convey complex regulatory concepts clearly.
• Team oriented approach with leadership skills to drive cross-functional collaboration.

Responsibilities

• Efficiently manage and execute all aspects of global start-up activities.
• Perform quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms.
• Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
• Present during bid defenses, capability meetings, and audits.

Skills

Clinical start-up management

Regulatory submissions

CRO experience

Job description

Medpace is seeking a Regulatory Submissions (Study Start-up) Manager for our UK Clinical Operations team. This office-based role focuses on leading global start-up activities, ensuring quality regulatory documents, and timely submissions.

You will coordinate informed consent processes, review regulations, and support audits and bid defenses. The ideal candidate has extensive CRO experience, European CTAs knowledge, and strong leadership and communication skills to drive cross-functional