Associate Director, Global Clinical Trial Studies

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INTERNATIONAL STAFFING CONSULTANTS, INC.

Employer Retained Global Staffing Since 1979

Details:

7/29/2022

j-25949

Permanent

Remote Available

$113,000 - $120,000 / yr

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Associate Director, Global Clinical Trial Studies

Toronto, ON

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This is a great opportunity to work with a world-renowned oncology research and development team to lead GLOBAL studies from early through late phase. On site in GTA office preferred / some remote OK.

Great company - leader in the field
Lots of room to move up
Interesting projects
Interaction with people all over the world
Bonus, great benefits, RRSP contribution, etc.

ROLE AND RESPONSIBILITIES:

Leading a cross-functional clinical study team from onset of study specifications to study archiving.
Help team deliver studies or projects, meeting time, budget, quality, following ICH/GCP and company SOPs.
Serve as contact for CRO project manager to ensure work outsourced to CRO follows company guidelines.
Keep global study plans up to date.
Study budgets.
Risk and contingency planning.
Development of critical study level documents, such as Clinical Study Protocol.
Select and lead vendors.
Training for local and site teams and participating in monitoring and investigators meetings.
Keep studies ready for inspection and meeting ICH-GCP and company SOPs.
Main point of contact re audit re Trial Master File TMF.
Adverse events collection.

REQUIREMENTS:

BS, B.Sc., MS, M.Sc., PhD biological sciences. PMP nice to have.
Background in oncology trials.
Min 7 years of relevant clinical experience in the pharmaceutical or CRO industry leading global trials.
Great grasp of study management and clinical operations, phases of development, and therapy areas.
Min 5 years global clinical project management experience.
Cross-functional team leadership, budgets.
Strong communication skills, able to build positive relationships, and vendor leadership skills.

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