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) leads selected activities in the delivery of medical evidence studies, with main focus on secondary data studies. EAM is partnering with TA epidemiologist who serves as scientific study leads, collaborates with study team members and coordinates study operational activities to ensure study delivery to time, cost, and quality. EAM is

also proactively supporting development of best practices, to ensure consistency and continuous improvement of our ways

of working, to ensure efficacy and simplification.

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

• Provide operational support during study process, governance, audits and regulatory inspections, according to company policies, SOPs and regulations
• Collaborates with the study team and contribute towards start-up, execution, close out and reporting of studies
• 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. 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
• 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
• Ensure project status reports reflect on the complete and current project information in company systems like Evidence Connect and IMPACT
• 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)
• 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

Essential

• Bachelor’s degree in biological science, public health or healthcare-related field
• Minimum 3 years’ experience in clinical experience working with international teams
• Solid knowledge and understanding of the clinical/ non-clinical study and drug development processes, Good Pharmacoepidemiology Practice, GCP/ICH guidelines
• Demonstrated ability to set and manage workload priorities, resources, performance targets and project initiatives for projects or teams; able to respond quickly to shifting demands and opportunities
• Proactively identify risks and possible solutions
• Team oriented and flexible; Demonstrate ability to work independently, as well as in a team environment
• 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
• Excellent written and verbal communication and presentation skills; proven collaboration and influencing skills
• Excellent knowledge of spoken and written English

Desirable

• Working knowledge across the BPM Evidence EGA and an understanding of the range of working procedures relating to them

• Evidence of working effectively with both internal and external stakeholders across regions, functions and cultures in a matrix organisation
• Project Management certification, or demonstration of project management skills
• Vendor contracting and Study budget management experience

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.