We are seeking a Study Start Up/Regulatory Submissions Manager to join our Clinical Operations team in Melbourne, Australia.
Responsibilities:
* Manage and execute all aspects of global start-up efficiently;
* 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.
Requirements:
* More than 5 years of experience in clinical research, preferably with a Contract Research Organization (CRO). Experience may include CRA or project management experience;
* Regional experience is highly advantageous;
* Strong oral and written communication skills.
Seniority level:
Mid-Senior
Employment type:
Full-time
Job function:
Science and Other
Industries:
Pharmaceutical Manufacturing