Senior Study Manager, Clinical Trials

Translational Research in Oncology - Edmonton, AB (il y a 30+ jours)

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TRIO (Translational Research in Oncology) is a not-for-profit clinical research organization that is dedicated to advancing translational cancer research by pursuing forward innovative and targeted therapeutic concepts in the clinical trial setting. We are committed to providing treatments of the future to the world of today.

TRIO's head office is in Edmonton, Alberta with operations all throughout Canada, the USA, France and Uruguay. TRIO is looking for a Senior Study Manager to join the Project Management team in the Edmonton office.

Responsibilities

A Senior Study Manager typically manages one trial and assists a Global Project Coordinator on another trial with the following responsibilities:

Define trial timelines and resources,
Coordination of the overall conduct of the trial,
Organization of regular teleconferences with other TRIO departments in order to ensure alignment on trial status, priorities and upcoming milestones,
Reporting to the Sponsor on trial progresses (through phone conferences/reports),
Define operational trial documents/processes and preparation of global communications to sites/CRAs,
Preparation of training material and presentation to sites and CRAs on the trial/global calls,
Actively coaching direct reports to grow and achieve effective performance within their respective roles,
Oversight of trial activity performed by PM team members and follow-up on metrics associated to the activity performed,
Oversight of the activity performed by Third Party Organizations (TPOs) at trial level and country level,
Quality Controls (QCs) of the files at the trial level and follow-up with other PM team members until resolution of any issue detected during these QCs,
Data QCs in order to guarantee adequate data quality prior to database lock/freeze,
Identify the need for performing Change Orders when scope of activity changes on the trial,
Support to finance on site fees payments questions and site fee reconciliation,
Participation in Sponsor audits, preparation of answers to audit findings at trial level; support to the Study Managers in answering site audit findings.

Qualifications:
Minimum Bachelors degree with a scientific focus.
At least, 5 years of experience in monitoring or coordination of clinical projects.
Oncology experience (at least 2 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.

What we can offer you

Competitive salary
3 weeks of vacation
5% RRSP contributions by TRIO
Life, health, & dental premiums paid by TRIO.
$60 monthly transportation allowance

We thank all candidates for their interest; only those selected for an interview will be contacted.

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