Clinical Project Manager (CRO)

Care to join the team?

An exciting opportunity now exists for an experienced Clinical Project Manager to join GenesisCare CRO on a 6-month maximum term contract. We are always improving, designing new and higher standards for clinical excellence and trial execution.

This role will be accountable for project management of clinical trials within GenesisCare CRO and can be based anywhere throughout Australia.

More specifically, you will:

• 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. This may include supporting vendor selection.
• Work closely and effectively with sponsor study teams. Make recommendations to and seek guidance from the sponsor or the project leader.
• Provide clear project direction particularly 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, prepares 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 (e.g., Labs, clinical trial supply companies, courier etc) and coordination of activities.
• Actively coordinate and participate in Investigator Meetings as required.
• If required, support research Business Development in the Request for Proposal (RFP) and Bid Defence processes through supporting the development of initial project plans, costings, drafting responses to RFPs and participating in client presentations.
• Manage and process project finance of work orders/change order with sponsor and vendors. Effectively manage revenue, forecast, accrual of work orders and process billing and invoices.

We’re looking for someone who has:

• 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 (project management, medical monitoring, site management, pharmacovigilance, quality assurance, data management, vendor management etc).
• 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 of joining our team:

• 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.
• All employees and their family members have access to free confidential support that is completely external to GenesisCare including financial, nutritional and wellbeing coaching, legal advice & counselling.
• Range of benefits available: Qantas membership discount, gym membership discount, 12 weeks paid parental leave, Bupa discount.

About GenesisCare CRO
People centricity is at the heart of what we do whether that person is a patient, a referring doctor, a partner or someone in our team. We aim to build 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.

Covid19 Vaccination Requirement
In line with the Public Health Order, all GenesisCare employees are required to be fully vaccinated for COVID-19. To be eligible for consideration to perform work for GenesisCare, all recruits must provide evidence of vaccination and comply with the requirements of the Public Health Order prior to appointment.