Clinical Trials Project Manager
Clinical Project Management Team | Full-time | Location – Remote or Hybrid. Head Office: Vancouver, BC
Syreon's Clinical Project Management Division is looking for a Clinical Project Manager (CPM) to join our multi-disciplinary unit in the ongoing support of cutting-edge research projects. The CPM will work cohesively with all internal departments and external clients, such as Study Sponsors, Monitors, Investigators, Site Coordinators, Scientific Advisory Committee, Central Ethics Boards, QA, and third-party vendors to facilitate a wide range of project activities.
The successful applicant will have extensive experience with the development, implementation, and ongoing management of research studies. The CPM is responsible for providing ongoing direction to the internal study team during all phases of the study from development to close-out.
SYREON is a full-service Contract Research Organization. We combine elite biomedical sciences, advanced technologies, and global clinical trial networks to speed the evaluation of new drugs, diagnostics and medical devices and guide their safe, effective, and cost-efficient clinical use. We conduct international clinical trials and health economics and outcomes research across a broad range of chronic and rare diseases.
In this role, you will:
- Manage the study team to ensure all deliverables are met via project team meetings and ad hoc discussions
- Be the primary point of contact for the Study Sponsor and lead study teleconferences
- Develop study documents including Project Plans and Risk Management Plans
- Review study documents from other departments such as CRFs, Data Management Plan, Data Validation Document, CRF Completion Guidelines, Safety Management Plan, Statistical Analysis Plan, Clinical Study Report
- Review study protocols, informed consent templates and prepares Central Ethics Boards submissions and resubmissions as required
- Planning, coordination, and presentation at Investigator's Meeting(s)
- Set-up, collect, and maintain Trial Master Files
- Set-up and distribution of Site Investigator Binders
- Recruits, trains, and provides ongoing support to participating sites, study monitors, Sponsors, and third-party vendors
- Development and execution of Site Recruitment strategies
- Review of monthly study pass-thru account statements and study budgets to ensure adherence to budget
- Reviews study database and processes in collaboration with data management team, as required
To be successful in this role, you likely have:
- BSc in life sciences or medically related field, preferably OR five to eight years of industry experience within life sciences; or a minimum of five years of experience as a Clinical Research Coordinator
- Excellent Clinical Research/Clinical Trials knowledge
- Excellent knowledge and understanding of ICH/GCP/FDA and Health Canada Regulations
- Strong written and verbal communication sills, and strong presentation skills
- Strong problem-solving skills
- Strong ability to work in a fast-paced environment; ability to prioritize, and work with speed and accuracy
- Excellent competency in MS Word, Excel, PowerPoint, analytical techniques, and database applications
- Excellent ability to work independently and effectively in project teams, take ownership and responsibility for actions
Benefits
- 3 weeks of paid vacation and paid sick days
- Extended health & dental
- Flexible work option
Find out more:
For more information about Syreon, please visit our website: www.syreon.com
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