Senior Study Manager - Romania in Bucuresti

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer 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 Study Manager to join the Project Management team. Senior Study Manager Position Overview:This position reports to:Global Project Coordinator (GPC) or Director of Project Management (PM)This position supervises: Study Manager (SM), Data Validation Specialist (DVS), Administrative Project Coordinator (APC), General Administrative Clerk (GAC) involved in the projectKey relationships are maintained with: All departmentsResponsibilities: 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),Definition of the 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,Support to the PM team, sites and CRAs with any questions they may have during the course of the trial, Eventual involvement in the identification of new Third Party Organizations (TPOs), 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,Determination of the need for performing Change Orders in case of scope of activity change 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, Participation in the revision/leads the revision of procedures involving the PM department,On similar less-extensive trials, a SSM may assume more responsibilities if no GPC is involved.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/GCPExperienced 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 TRIO Can Offer You:Competitive salaryPaid time off Flexible working hours Integrity • Teamwork • PassionPowered by JazzHR


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