Associate Director, Evidence Project Management I
4 tygodni temu
Description
of Services)• Co-ordinate/manage timely contributions of AZ core/extended members
• Interface with key stakeholders cross-functionally, and/or external partners, to identify, manage 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 essential 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, manage study spend within available budget & agreed tolerances
• Manage/oversee 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, milestones 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 stakeholders
• Oversee 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 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 escalations with internal and external stakeholders
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
▪ Proven 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
▪ Proven ability to interact widely and effectively within the company across regions, functions and cultures
▪ Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
▪ Strong strategic and critical thinking abilities
▪ Strong organizational and problem-solving skills
▪ Ability to manage competing priorities
Desirable:
▪ Experience and knowledge within compliant 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
Date Posted
31-maj-2024Closing Date
29-cze-2024-
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