Clinical Trial Manager (Immunology)
Medpace · South Yarra
Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers and Project Managers with a focus in Immunology to join our Clinical Trial Management Group in our Melbourne, Australia office. This is the lead role for multiservice global/regional clinical trials, interacts with sponsors and sites and manages the timeline and project deliverables (minus finance). This role coordinates all services contracted for the study, leading the cross functional team thru all life cycles of the project (from startup to database lock and closure). CTM will attend bid defense meetings and support business development activities, as needed.
Responsibilities
- Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
- Serve as primary Sponsor contact for project-specific issues and study deliverables
- Maintain in depth knowledge of protocol, therapeutic area, and indication
- Provide cross-functional oversight of project team members and deliverables, which includes ensuring all necessary project-specific training is provided
- Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
- Develop operational project plans
- Manage risk assessment and mitigations
- Manage study vendors
- Manage site quality, including direct supervision of project Clinical Research Associates (CRA) and monitoring deliverables
Qualifications
- Bachelor’s degree or above in health/life science related field;
- At least two years of clinical trial management experience in the Asia Pacific region; indications of interest a plus
- Prior CRO experience is preferred
- Excellent communication skills including good verbal and written English; and
- Flexible, accountable, and comfortable working in a global environment.
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.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
- Bachelor’s degree or above in health/life science related field;
- At least two years of clinical trial management experience in the Asia Pacific region; indications of interest a plus
- Prior CRO experience is preferred
- Excellent communication skills including good verbal and written English; and
- Flexible, accountable, and comfortable working in a global environment.
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