Associate Director, Evidence Project Management(Global Study Lead)
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The Medical Evidence Delivery Team within Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored scientific research (ESR) and early access programs (EAP) in order to generate the evidence to build confidence in and provide access to AstraZeneca therapies for patients in need.
Associate Director, Evidence Project Management (AD EPM) will lead the operational planning, delivery, oversight and budget management of company sponsored evidence studies and/or EAPs within the assigned therapeutic area (TA). This person is responsible for leading a cross-functional AstraZeneca (AZ) study team and supervising 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.
This person will also lead 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 standard processes and in line with AZ values and behaviours.
In addition, they 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 standard process, 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 pose the ability to handle an increased complexity, to lead departmental initiatives and to stretch up as needed.
Responsibilities:
Partner with direct manager, 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
Work with externally managed/outsourced partners for studies planning and delivery
Serve as the reference point for communication and escalation of issues
Mentor, coach and support the study team members.
Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of breakthroughs.
Be primary AZ point of contact for the CRO Project Manager to secure study delivery according to set criteria.
Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the study lifecycle in alignment with relevant AZ SOPs and guidelines (e.g. Sponsor Oversight Plan, 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 (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, 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 AZCHumanResources@astrazeneca.com.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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