Evidence Associate

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas – breast, ovarian, lung and haematological cancers. As well as other tumour types, these are being targeted through five key platforms – immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, HER2 and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

AstraZeneca’s Oncology portfolio includes Company Sponsored Observational and Interventional Research, Externally Sponsored Research and Early Access Programs.

As an Evidence Associate, within the Oncology Business Unit Medical Evidence Delivery Team at AZ you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing practice and patients’ lives. You will support evidence generating activities according to specific processes to help secure Oncology portfolio deliverables to time, cost and quality.

Typical Accountabilities | Job Responsibilities

• Assist the study team and contribute towards start-up, execution, close out and reporting of Company Sponsored studies, Externally Sponsored Research and Early Access Programs

• Coordinate administrative tasks during the lifecycle of a study, and in other instances such as 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-functional 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 (i.e. invoice reconciliation, Purchase Order management) to ensure they are effectively undertaken, studies are delivered to plan and study conduct documented

• Lead the setup, 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 compliance requirements are met, and supporting the Study Team in management and use of other study specific systems (i.e. ACCORD, Evidence Connect)

• Ensure project status reports reflect on the complete and current project information in company systems, such as Evidence Connect and IMPACT

• Provide administrative support towards the review of ESR submissions that enables timely and consistent approach to evaluation

• Support achieving quality and accuracy of data within the ESR registry and management tool (Evidence Connect) daily and completeness of documentation to enable teams to make effective business decisions

• Assist the study team and contribute towards start-up, execution, close out and reporting of Company Sponsored studies, Externally Sponsored Research and Early Access Programs

• Coordinate administrative tasks during the lifecycle of a study, and in other instances such as 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-functional 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 (i.e. invoice reconciliation, Purchase Order management) to ensure they are effectively undertaken, studies are delivered to plan and study conduct documented

• Lead the setup, 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 compliance requirements are met, and supporting the Study Team in management and use of other study specific systems (i.e. ACCORD, Evidence Connect)

• Ensure project status reports reflect on the complete and current project information in company systems, such as Evidence Connect and IMPACT

• Provide administrative support towards the review of ESR submissions that enables timely and consistent approach to evaluation

• Support achieving quality and accuracy of data within the ESR registry and management tool (Evidence Connect) 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 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 requirement Company sSponsored

• Where required input into functional work including training activities and development of procedures Observational and Interventional

• Lead the administrative support of key governing bodies (GREG and MEORT) 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 requirement Company sSponsored

• Where required input into functional work including training activities and development of procedures

Education, Qualifications, Skills and Experience

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

• Working knowledge across the AstraZeneca Oncology portfolio 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

• Demonstrate professionalism and mutual respect

• Willingness and ability to train others