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Associate Director, Evidence Project Management

3 months ago

Mississauga, Ontario, Canada AstraZeneca Full time

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 Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM /Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process) Maintain/report accurate cost forecasts throughout study, lead study spend within available budget & agreed tolerances Lead/be responsible for financial processes (PO's, invoicing, cost reconciliation etc.), may delegate as appropriate Responsible for setup of the study cost tracker Monitor study risks throughout delivery and oversee team in the development/implementation of mitigations and contingencies Oversee study/EAP level performance against agreed upon plans, achievements and key performance metrics, EAP exit strategy Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant collaborators Supervise periodic TMF QC and responsible for review of relevant sections/documents in accordance with SOP/Wiki

Specifically in the EAP space if assigned to, in addition to the above:

Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams Participate in operational governance activities related to agreed CRO strategic and operational governance principles Perform vendor oversight to ensure EAP delivery to time, cost and quality Collaborate with vendors to ensure the EAP operational aspects are effectively undertaken and that they have clear remits for delivery Manage resolution of program specific issues and partner concerns with internal and external team members

Requirements:

Essential:

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 Ability to mentor, develop and educate staff Leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives Ability to look for and champion more efficient and effective methods/processes of delivering evidence studies focusing on key performance metrics around reliability, efficiency, cost and quality Consistent record in interacting widely and effectively within the company across regions, functions and cultures Persuasive communicator in English with a proven track record to work collaboratively in a multi-cultural environment

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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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted

17-Jun-2024

Closing Date

30-Jun-2024