Global Study Associate Manager, Biopharmaceuticals
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Position Title: Global Study Associate Manager
PositionType: Full-Time, Contract (1 Year) in Study Management within the Biopharmaceutical Therapy Area
Location: Mississauga, Ontario
You are a member of the extended global study team supporting delivery of respiratory clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving. The GSAM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study.
- You will build partnerships functional authorities, internally and externally and provide oversight to ensure successful study delivery
- You will maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery.
- You will lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc) and external service provider related documents (e.g. specifications)
- You will support the Global Study Leader (GSL) in project management as per agreed delegation
- You ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers
- You help support the GSL with budget management, such as external service provider invoice reconciliation
- You make sure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines
- You will ensure that all study documents in scope of GSAM’s responsibilities are completed and verified for quality in the Trial Master File
- You will assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
- You will monitor study conduct and progress, dedicatedly identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Global Study Manager
- You will contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics
- You will have the opportunity to provide input into non-drug project work including training activities, and development of procedures as needed
- You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- Significant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years
- Shown project management, organizational and analytical skills
- Knowledge of clinical development / drug development process in various phases of development and therapy areas (respiratory TA knowledge would be an asset)
- relevant knowledge of international guidelines ICG-GCP
- Computer proficiency
- Excellent knowledge of spoken and written English
Next steps – Apply today
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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