In partnership with AZ enablement team, provide oversight to ensure study delivery.
Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, Master Clinical Study Agreement etc).
Maintain and facilitate interactions with internal functions including Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers.
Contribute to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting).
Ensure the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
Ensure that all study documents in scope of responsibilities are complete and verified for quality in Trial Master File.
Support Global Study Leader (GSL) with budget management, including invoice reconciliation.
Adhere to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and guidelines (e.g. ICH/GCP) to ensure study is inspection ready at all times.
Support GSL in project management as per agreed delegation.

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Knowledge of clinical development / drug development process in various phases of development and therapy areas.
Excellent knowledge of international guidelines ICH/GCP.
Excellent communication and relationship building skills, including external service provider management skills.
Good project management skills.
Demonstrated ability to collaborate as well as work independently.
Demonstrated leadership skills.
Computer proficiency, advanced computer skills in day-to-day tasks.
Experience in all phases of a clinical study lifecycle.
Basic knowledge of GXP outside of GCP (i.e GMP/GLP).
Excellent verbal and written communication in English.

Global Study Associate Manager

Key skills