TRIO’s head office is in Edmonton, Alberta with operations all throughout Canada, the USA, France, and Uruguay. TRIO is looking for a Senior Global Clinical Project Manager, internally referred to as a Global Project Coordinator, to join the Project Management team.
- Oversee the implementation and conduct of one or more trials.
- Defines/reviews and approves the trial activities timelines and resources of the different trials.
- Coordinates the overall conduct of the different trials by operating as a facilitator vis-à-vis the other TRIO departments involved in order to ensure alignment on trial status, priorities, and upcoming milestones.
- Reports to the sponsor on trial progress and implements remediation action plans in case of activities not progressing as expected.
- Defines and approves all trial operational documents pertaining to the trial.
- Prepares and/or reviews training material for sites, CRAs and performs presentations.
- Manages and provides support to direct reports and oversees the activity of all PM team members involved in the trials. Follows-up on metrics associated with the activity performed by the PM team members in order to implement remediation actions if necessary.
- Sets-up and oversees the activity performed by the Third Party Organizations (TPOs), as applicable, at the trial level and organizes regular teleconferences with these TPOs in order to follow-up on the activities they perform.
- Works with all TRIO departments in order to ensure adequate data quality prior to database lock/freeze.
- Determines the need for Change Orders in case of the scope of activity change on the trial; is involved in monthly budget reconciliations and Change Orders preparation when need be.
- Participates in sponsor audits, prepares answers to audit findings at the trial level; supports the Study Managers in answering site audit findings.
- Participates, as required, in bid defense meetings organized with potential sponsors in order to secure new projects for TRIO.
- Works closely with the Project Management Director in order to define required process changes impacting the Project Management department.
- Minimum Bachelors degree with a scientific background.
- At least, 10 years of experience in monitoring or coordinating clinical projects.
- Oncology experience (minimum of 5 years experience working on oncology trials).
- Excellent knowledge of ICH/GCP
- Experienced in managing staff, remotely and in the office.
- Advanced proficiency in MS Office specifically in Word, Excel, MS Project, and PowerPoint.
- Excellent communication skills, both in written and oral.
- Ability to present in public and to interact with Sponsors.
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