Regulatory Submissions (Study Start-up) Manager

Medpace, Inc.; Melbourne; Presencial; AUD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation programs

Comprehensive health and retirement

Office-based culture with occasional W

Company-sponsored social events

Descripción de la vacante

Medpace, Inc. seeks a Regulatory (Study Start Up) Submissions Manager for a full-time, office-based role in Melbourne, Australia. You will manage global start-up activities and ensure timely regulatory submissions to support clinical programs.

Ideal candidates have 5+ years in clinical research, preferably with a CRO, strong oral and written communication, and regional experience. Hybrid working arrangements may be available after training.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory submissions

Clinical research

Communication skills

Descripción del empleo

Job Summary

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) 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.