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 (EA) supports and coordinates Evidence Generating Activities (EGA) and contributes to the operational activities to ensure consistency of BPM Evidence deliverables to time, cost, and quality. 

EGA portfolio supported includes Company Sponsored Observational and Interventional Research, Externally Sponsored Research and Early Access Programs. The EA, by supporting specific processes and workflows, acts as a point of contact for the administrative, technical and execution support towards the assigned study teams, stakeholders, functions and/or systems.

Typical Accountabilities | Job Responsibilities

• Assist the study team and contribute towards start-up, execution, close out and reporting of studies
• Coordinate administrative tasks 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 ensuring the Company compliance requirements are met, and supporting the Study Team in management and use of other study specific systems (i.e. ACCORD)
• 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 daily and completeness of documentation to enable teams to make effective business decisions
• Lead the administrative support of key governing bodies (GREG and ERT ) and other relevant meetings, 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
• Provide administrative and operational support during study close out and lead the archiving activities in line with the Company SOPs and requirementCompany sSponsored

Essential

• Bachelor’s degree in biological science or healthcare-related field
• Knowledge of the clinical study and drug development processes, GCP/ICH guidelines
• Excellent written and verbal communication skills as well as proven collaboration and organizational skills
• Excellent knowledge of spoken and written English
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Desirable

• Consistent demonstration of the AZ Values and Behaviours
• Develop working knowledge across the BPM Evidence EGA and an understanding of the range of working procedures relating to them
• Ability to develop advanced computer skills to increase efficiency in day to day tasks
• Demonstrate ability to work independently, as well as in a team environment
• Ability to prioritise and manage multiple tasks with conflicting deadlines
• Good interpersonal skills and ability to work in a team environment
• Proactively identify risks and possible solutions
• 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
• Willingness and ability to train others

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.