Clinical Project Manager

August 26

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Syreon Corporation

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Transforming research in rare and complex diseases

Phase I-IV trials • Health Economics and Outcomes Research • Strategic Pricing and Value Dossier • Precision Medicine Trials • Pragmatic Trials

51 - 200

Description

• 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

Requirements

• 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 skills, 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