Evidence Delivery Manager
Location: Cambridgeshire, Gaithersburg, Maryland, Wilmington, Delaware
Job Type: Full time
BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. BPM aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.
The BioPharmaceuticals Medical Evidence organization is accountable for the operational delivery of global strategic studies required to generate the evidence to build the confidence on AZ therapies and additional observational, interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.
Evidence Delivery Managers (EDM) will lead or support the operational planning, delivery, oversight and budget management of externally sponsored research. They may also help coordinate the efforts of extended team members, notably the scientific study. The EDM may own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.
In addition, the EDM will support BPM 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.
The EDM will focus on the allocated portfolio of Externally Sponsored Scientific Research (ESR):
Supports the review of ESR proposals and protocols to enable a consistent, high quality approach to evaluation
Manage across a range of global and local cross-functional stakeholders to ensure all AZ obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met
Manage external stakeholder, e.g. external Investigator and Sponsoring institutions
Support ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals)
Provide oversight to local Marketing Companies (MC’s) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate
Lead and manage aspects of the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research projects
Acts as the first point of contact for local MC operational enquiries
Tracks all ESR study time, cost and quality KPIs, taking corrective action as required. In doing so, guides the MC in the changing of ESR study milestones and finances in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met
Ensure operational quality and compliance with policies and procedures for ESRs globally
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.
Scientific awareness and extensive knowledge of observational study guidelines and SOPs
Extensive knowledge of early and late stage Pharmaceutical Development
Ability to effectively work with Clinical Research Organisations/External Providers.
Proven ability to interact widely and effectively within the company across regions, functions and cultures.
Experience and knowledge within compliant management of Externally Sponsored Scientific Research
Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.