Clinical Project Manager

2 days ago

Sydney, New South Wales, Australia GenesisCare Full time
Clinical Project Manager Job Description

We are seeking an experienced Clinical Project Manager to join our team at GenesisCare CRO. As a Clinical Project Manager, you will be responsible for the management of clinical trials within GenesisCare CRO, working on a permanent, full-time basis.

This role will involve project managing assigned activities related to the management of multinational and local clinical trials from phase 1-4 and clinical registries. You will be responsible for managing the planning, implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated projects.

Key Responsibilities:

  • Project manage assigned activities related to the management of multinational and local clinical trials from phase 1-4 and clinical registries.
  • Manage the planning, implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated projects.
  • Act as the point of contact for assigned projects for sponsor and internal study teams.
  • Ensure clinical research projects are properly resourced, managed, executed, and reported within budget and in accordance with established timelines and quality standards.
  • Work closely and effectively with sponsor study teams, making recommendations and seeking guidance as needed.
  • Provide clear project direction to those sponsors who may be inexperienced in drug/device development.
  • Maintain effective professional relationships with sponsor, external customers, investigators, vendors and the internal project team.
  • Provide clear guidance to the project team on project specific deliverables as defined in contracts and project specific documentation.
  • Oversee the preparation of study essential documents, including protocol, amendments, CRF, informed consent form, operations and other documentation required for conduct of a clinical trial.
  • Oversee and manage internal clinical trial files and documents (eTMF).
  • Manage the day-to-day study operations, including management of vendors and coordination of activities.
  • Actively coordinate and participate in Investigator Meetings as required.
  • Support research Business Development in the Request for Proposal (RFP) and Bid Defence processes, as needed.
  • Manage and process project finance of work orders/change order with sponsor and vendors, effectively managing revenue, forecasting, and billing.

Requirements:

  • Minimum Undergraduate degree in Life Sciences.
  • Minimum of 3-4 years' experience in clinical research project management in CRO (strongly preferable), Pharmaceutical and/or Biotechnology.
  • Formal project management certification desirable.
  • Proven track record of having successfully led clinical trials, with experience leading all functional capabilities involved in CRO-directed clinical research.
  • Demonstrable experience in vendor management.
  • Deep understanding and comprehensive practical knowledge of ICH-GCP requirements, including across different jurisdictions.
  • Understanding of clinical trial budgets, client and site contracts and client billing.
  • Experience working in Oncology therapeutic areas highly preferable.

Benefits:

  • Engaging work environment that promotes collaboration within the multi-disciplinary team.
  • Internal career development opportunities nationally.
  • Working with a vibrant team aligned with providing the best patient experience possible and outcomes.
  • Access to confidential support services, including financial, nutritional and wellbeing coaching, legal advice & counselling.
  • Range of benefits available, including Qantas membership discount, gym membership discount, 12 weeks paid parental leave, Bupa discount.

About GenesisCare CRO:

At GenesisCare CRO, we are committed to building a culture of care that is patient-focused and performance-driven. Our people promise is 'do your life's best work, by always growing, having a profound human impact and making great things happen together.' If you'd like to make a difference, join us at GenesisCare CRO.

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