We are seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia.
Key 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 pertinent regulations to develop proactive solutions to start-up issues and challenges;
* Present during bid defenses, general capabilities meetings, and audits.
Qualifications and Experience
* More than 5 years of experience in clinical research, preferably with a CRO. CRA or project management experience is also valuable;
* Regional experience will be highly advantageous;
* Strong oral and written communication skills.
About Medpace
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 our scientific and disciplined approach.
Why Choose Medpace?
We offer a dynamic work environment, competitive compensation and benefits package, flexible work arrangements, and opportunities for professional growth and development.
Awards and Recognition
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024;
* Recipient of CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.