Regulatory Submissions (Study Start-Up) Manager

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

Regulatory Submissions (Study Start-up) Manager

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based, Regulatory Submissions Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Efficiently manage and successfully execute all aspects of global start-up;
• 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; and
• Present during bid defenses, general capabilities meetings, and audits.

Qualifications

• Extensive experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
• Knowledge and experience of Clinical Trial Applications within Europe;
• Strong oral and written communication skills; and
• Team oriented approach and strong leadership skills.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust. Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.