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Associate Director, Evidence Project Management I, II (AD EPM) will lead the operational planning, delivery, oversight and budget management of company sponsored evidence studies and/or early access programs (EAP) within the assigned therapeutic area (TA). The AD EPM is responsible for leading a cross-functional AstraZeneca (AZ) study team and overseeing the CRO study team as well as for providing the teams with direction and guidance to enable successful study and/or EAP delivery. The AD EPM is the main liaison between the AZ and CRO teams and is accountable for the delivery of a study and/or EAP according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and external partners.

The AD EPM leads the study and/or EAP team in accordance with the clinical outsourcing model (i.e. EMPOWER, early access principles), current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices and in line with AZ values and behaviours.
In addition, the AD EPM will support OBU Medical Evidence’s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.
Associate Directors, Evidence Project Management II are the group of most experienced AD EPMs who will serve their less experienced colleagues as mentors. They poses the ability to handle an increased complexity, to lead departmental initiatives and to stretch up as needed.

Responsibilities:

• Partner with Dir EPM ensuring provision of expertise and operational input into the programs (e.g. IMAP, ERT, MARCO, SDC, CSP)
• Collaborate with Dir EPM /Sr Dir EPM and provide adequate input to enable effective CRO selection
• Study-level interface with externally managed/outsourced partners for studies planning and delivery
• Serve as main point of contact for communication and escalation of issues
• Mentor, coach and support the study team members (i.e. Evidence Project Management Managers, Sr Specialists, Specialists)
• Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of milestones
• Be primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards
• Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study in accordance with relevant AZ SOPs and guidelines (e.g. Sponsor Oversight Plan, 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 (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
• Ensure all required External Service Providers (e.g. 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