Why a Great Opportunity
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).