Global Clinical Trial Study Leader - Toronto, Ontario Canada - 36163

JOB DESCRIPTION

WHY IS THIS A GREAT OPPORTUNITY?

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Big Pharma

Very stable employer, expanding rapidly, lot of room for professional growth

Work on the forefront of new drug development R&D in atmosphere that favours learning and mentoring

JOB DESCRIPTION

Global Clinical Trial Study Leader - Toronto based - Permanent, full time

Covering either Respirology OR Cardiovscular. Will be responsible for trials

from beginning to end.

ROLE AND RESPONSIBILITIES:

• Clinical Trial Project Management.
• Stakeholder leadership.
• Global team leadership.
• Mentorship and point of contact for study directors.
• ICH / GCP, documents, study plans and budgets, trial master files.
• No direct reports, but responsible for cross-functional reams.
• Entire process, going from design to protocols, vendor selection, patient recruitment.
• Mostly phases II and III.

 

QUALIFICATIONS

REQUIREMENTS:

• M.Sc., Ph.D., Pharm.D., MD.
• Project and team leadership background essential.
• Min 6 to 10 years' related experience in pharma or in a CRO leading trials.
• Must have worked on large projects.
• Experience in Development Operations (CRA / Sr. CRA / GAM/GSAM) or other related fields.
• Must really understand the clinical trial process, ICH / GCP, documents. 
• Clinical project management (PMP / PMI attractive).
• Solid comprehension of clinical trial management.
• Preferably background in a large pharmaceutical company but CROs considered.

Three most important skills:

  1) Team leadership even though no direct reports - dealing with cross functional teams

  2) Stakeholder leadership

  3) Project Management skills (PMI would be a big asset).

Education:
University - Master's Degree