Regulatory Submissions (Study Start-up) Manager

Medpace; Stirling; On-site; GBP 55,000 - 85,000; Full time

Benefits offered by this job

Competitive compensation

Health benefits

Retirement benefits

PTO benefits

WFH after training

Social events

Job summary

Medpace is seeking a Senior Start-Up professional to lead global start-up activities, ensuring timely submission and quality control of essential documents. The role involves preparing informed consent forms, reviewing European regulatory requirements, and supporting bid defenses, capabilities meetings, and audits.

The ideal candidate has extensive clinical research experience, CRO exposure, and strong communication and leadership skills to drive cross-functional collaboration.

Qualifications

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

Responsibilities

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

Skills

Clinical research experience

CRO experience

Communication skills

Leadership

Job description

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.