Regulatory Submissions (Study Start-up) Manager

Medpace; City of Melbourne; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Job summary

A leading clinical research organization is seeking a full-time Regulatory (Study Start Up) Submissions Manager in Melbourne. The role involves managing global start-up processes, performing quality checks on documents, and preparing consent forms. Candidates should have over 5 years in clinical research, with strong communication skills being essential. This position allows for potential hybrid working arrangements, promoting flexibility and professional growth in a rewarding work environment.

Qualifications

• More than 5 years of experience in clinical research, preferably with a CRO.
• Regional experience will be highly advantageous.
• Strong oral and written communication skills.
• With potential hybrid working arrangements

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.
• Present during bid defenses, general capabilities meetings, and audits.

Skills

Clinical research experience

Strong oral communication skills

Strong written communication skills

Project management experience

Job description

Overview

We are currently seeking a full-time, office-based Regulatory (Study Start Up) Submissions Manager to join our Clinical Operations team in Melbourne, Australia.

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

• More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
• Regional experience will be highly advantageous;
• Strong oral and written communication skills;
• With potential hybrid working arrangements

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.