Join our close-knit project team in Australia. We are growing and currently have an opening for an experienced Project Manager to oversee Phase I studies in healthy volunteer subjects.
- Oversee and manages domestic, regional and/or international clinical trials conducted at Labcorp Clinical research sites, external sites, and data services projects.
- Manage scope of project and project components, budgets, timelines, and quality guidelines thereby ensuring that expectations are met while identifying and mitigating risks.
- Manage the project team in a matrix environment.
- Create and/or review required project plans. Implement and monitor progress against project.
- Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client.
- Increase potential for repeat business by establishing a strong working relationship with the client project team striving for client satisfaction and operational excellence.
- Responsible for the oversight of site start up activities.
- Oversee the coordination of the study activation components of the project from an oversight level including Feasibility, Site selection, Activation, Site Contracting, Regulatory Submission, Greenlight.
- Assist in the design and maintenance of tools/ processes relevant to feasibility assessments and patient recruitment campaigns.
- Supervise Investigator package review and approval prior to drug shipment.
- Supervise study set-up with the clients regarding pre-study documentation for Investigator packages.
- Supervise Site Budget and Statements of Agreement (SoA) documents that leads to an executed site contract.
- Supervise Document Review, including Informed Consent Forms, Advertisements, labels and protocols.
University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
In lieu of the above requirement, candidates with a 2-year Associate Degree and additional 5 or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Clinical Research - PMP, SOCRA/ACRP Certification
Masters or other advanced degree.
Five years' relevant clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.
In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, biometrics clinical supervision, clinical study management, clinical monitoring, and clinical project management may be considered.
- Experience in managing projects in a virtual environment.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to track project progress against financial milestones.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions.
- Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
- Good computer skills with good working knowledge of a range of software packages.
- Detailed knowledge of project management processes.
Working knowledge of Labcorp Drug Development with cross functional department expertise.
Basic knowledge of Labcorp Drug Development sales and business development strategies and procedures.
Working knowledge of Labcorp Drug Development SOPs.
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