External Title Clinical Trial Manager (Immunology)

Medpace

Melbourne

Hybrid

AUD 90,000 - 130,000

Full time

5 days ago
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Benefits offered by this job

Competitive compensation
Comprehensive health, wellness, and 退休
Work from home flexibility after培训
Office-based culture with mentoring

Job summary

Medpace, a leading CRO, is seeking an External Title Clinical Trial Manager (Immunology) to lead multiservice global/regional trials from Melbourne. You will coordinate services, manage timelines, and drive cross-functional teams through startup to database lock.

The role requires a Bachelor’s degree in health or life sciences, at least two years of APAC trial management experience, and strong English communication.

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.
  • Prior CRO experience is preferred.
  • Excellent communication skills including good verbal and written English.
  • Flexible, accountable, and comfortable working in a global environment.

Responsibilities

  • Manage day-to-day operations of the project per contract and ICH/GCP standards.
  • Serve as primary Sponsor contact for project-specific issues and study deliverables.
  • Maintain knowledge of protocol, therapeutic area, and indication.
  • Provide cross-functional oversight of project team members and ensure training.
  • Review study protocol, edit check specs, data analysis plan, and final study report when applicable.
  • Develop operational project plans.
  • Manage risk assessment and mitigations.
  • Oversee site quality and supervision of CRAs and monitoring deliverables.

Skills

Communication skills
English proficiency
Global collaboration
Flexible / accountable

Education

Bachelor’s degree or above in health/life science

Job description

External Title Clinical Trial Manager (Immunology)

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 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
  • 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
  • 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.

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