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Clinical Trial Manager (Infectious Disease)

Clinical Trial Manager (Infectious Disease)

MedpaceMelbourne, Australia
22 days ago
Job description

Overview

Medpace is currently looking for an experienced Clinical Trial Manager (CTM) specialised in Infectious Disease to lead global clinical research studies. Medpace is a scientifically led organization offering full-service solutions for our clients, giving the Medpace project teams the empowerment to truly lead and execute clinical trials. The Clinical Trial Manager position is the lead role for multiservice global / regional clinical trials. The CTM 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. This position is office based.

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
  • Flexible, accountable, and comfortable working in a global environment
  • Medpace Overview

    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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

    Why Medpace?

    People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

    The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

    Medpace Perks

  • Flexible work environment
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Awards

  • Recognized by Forbes as one of America\'s Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
  • What to Expect Next

    A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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    Clinical Trial Manager (Infectious Disease) • Melbourne, Australia

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