At a Glance
- Tasks: Manage global start-up processes and ensure quality submissions in clinical research.
- Company: Join Medpace, a leading clinical research organisation with a mission to improve patient outcomes.
- Benefits: Competitive pay, health benefits, flexible work options, and ongoing professional development.
- Other info: Dynamic team culture with mentorship and clear career advancement paths.
- Why this job: Make a real impact in advancing medical therapies while growing your career.
- Qualifications: 5+ years in clinical research, strong communication skills, and experience with CROs preferred.
The predicted salary is between 82800 - 101200 $ per year.
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;
- 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
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.
Regulatory Submissions (Study Start-up) Manager employer: Medpace, Inc.
Medpace is an exceptional employer for those looking to launch their careers in clinical trial management, particularly in the vibrant city of Melbourne. With a strong focus on employee growth, Medpace offers comprehensive training programs, clear career advancement paths, and a collaborative work culture that fosters innovation and open communication. Employees benefit from competitive compensation, health and wellness programs, and a supportive environment that encourages professional development and meaningful contributions to advancing medical therapeutics.
