BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (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 AZ 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.

The Evidence Associate Manager (EAM) supports and coordinates Medical Evidence Generating Activities (EGA) and contributes to the operational activities to ensure consistency of BPM Evidence deliverables in time, cost, and quality with responsibility for operational coordination of EGA which includes supporting best practices, efficacy and simplification.

The EGA portfolio supported includes Company sponsored studies, Externally Sponsored Research and Early Access Programs. The EAM interfaces with global and local Medical Affairs, cross-functional teams and those external to the Company. As a technical and process champion for a specific area, process or system within study delivery is the point of contact to provide guidance on best practice. Is responsible for maintaining guidance documents and ways of working, amending and driving the change where appropriate.

The EAM acts as a Team Leader in relation to the administrative, technical and execution support provided by (Senior) Evidence Associates. As Team Leader is responsible for mentorship and capability development in the Team but also representing the Team in interactions with the broader organization.

Typical Accountabilities

• Assist the study team and contribute towards start-up, execution, close out and reporting of studies
• Lead the coordination of administrative tasks and provide operational support during study process, governance, audits and regulatory inspections, according to company policies, SOPs and regulations
• Lead the collection, review and tracking of Essential Documentation, key correspondence and other relevant study documentation ensuring storage, formatting and version control is compliant with Company Procedures, document retention guidelines, industry standards and the applicable laws
• Interface with Strategic Partners and other Contract Research Organisations (CROs) & External Service Providers (ESPs) as well as internal cross-function teams to complete activities relating to the assigned processes, systems and projects
• Support study teams in monitoring and overseeing the operational and financial aspects of CRO/ESP collaboration to ensure they are effectively undertaken, studies are delivered to plan and study conduct documented
• Lead the set up, maintenance and archiving of the electronic Trial Master File (eTMF) in line with the Company SOPs and applicable laws
• Support import of applicable documentation into the Company Global Document Electronic Library (ANGEL) according to the relevant procedures, publishing standards and the applicable technical requirements associated with Submission Ready Standards (SRS) for delivery of documentation to regulatory authorities
• Set-up, ongoing maintenance and closure of all study related Company tracking systems and communication tools (i.e. IMPACT, Evidence Connect, SharePoint, collaborative study folders on BOX) ensuring the Company minimum compliance requirements are met, and supporting the Study Team in management and use of other study specific systems (i.e. ACCORD, Vision Tracker)
• Ensure project status reports reflect on the complete and current project information in company systems like Evidence Connect and IMPACT
• Provide administrative support towards the review of ESR proposals that enables timely and consistent approach to evaluation
• Support achieving quality and accuracy of data within the ESR registry and management tool (VisionTracker) daily and completeness of documentation to enable teams to make effective business decisions
• Lead the administrative support of key governing bodies (GREG and MEORT) and other meetings where CRO/ESP is not contracted, ensuring efficient execution of the meeting and creation of documented evidence of decisions, actions and participation
• Provide the operational support for studies post database lock, prior to CSR finalisation
• Lead study close out and archiving activities in line with the Company SOPs and requirementCompany sSponsored
• Provide input into functional work including training activities and development of procedures, guidance and ways of working and capability development
• Lead the capability development within the team of Evidence Associate
• Act as the main point of contact and manage the guidance documentation, ways of working and procedures for the allocated area of responsibility
• Provide execution and operational expertise within allocated area of responsibility

Education, Qualifications, Skills and Experience

Essential:

• Minimum 3 years’ experience in clinical experience working with international teams
• Bachelor’s degree in biological science or healthcare-related field
• Solid knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines
• Excellent written and verbal communication skills as well as proven collaboration and influencing skills
• Excellent knowledge of spoken and written English
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Proactively identify risks and possible solutions
• Project Management certification, or demonstration of project management skills
• Demonstrated ability to set and manage workload priorities, resources, performance targets and project initiatives for projects or teams
• Ability to identify and champion more efficient and effective methods/processes whilst operating with required policies and regulations
• Consistent demonstration of the AZ Values and Behaviours

Desirable:

• Working knowledge across the BPM Evidence EGA and an understanding of the range of working procedures relating to them
• Demonstrate ability to work independently, as well as in a team environment
• Good interpersonal skills and ability to work in a team environment
• Demonstrate concern of standards, concern of impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control and tenacity
• Demonstrate professionalism and mutual respect
• Evidence of working effectively with both internal and external stakeholders across regions, functions and cultures in a matrix organisation.

Date Posted

Closing Date

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.