Associate Director, Evidence Project Management
1 month ago
Description of Services
- Co-ordinate/lead timely contributions of AZ core/extended members
- Collaborate with key partners cross-functionally, and/or external partners, to identify, handle and resolve issues affecting study delivery
- Review protocol drafts and input operational perspectives/content into document and authoring team discussions
- Provide input into and/or quality review and hold accountability for the development of crucial study level documents (ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
- Ensure all required External Service Providers (CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
Requirements:
- Bachelor’s degree required preferably in medical or biological science or equivalent by experience
- Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
- Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
- Ability to effectively work with Clinical Research Organisations/External Providers
Desirable:
- Experience and knowledge within compliance management of Early Access Program
- Advanced degree in medical or biological sciences or field associated with clinical research
- Experience of incorporating digital health and patent centric strategies into clinical studies
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