BPM Evidence Associate (fixed term/secondment)

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 Global Evidence Portfolio Delivery 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 BPM 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.

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 (i.e. invoice reconciliation, Purchase Order management) 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 (ERV) 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. Veeva Clinical Vault, Veeva Quality Vault, collaborative study folders on SharePoint, TRIALSCOPE DISCLOSE) ensuring the Company compliance requirements are met, and supporting the Study Team in management and use of other study specific systems (i.e. ACCORD, COUPA)
• Ensure project status reports reflect on the complete and current project information in company systems like Veeva Clinical Vault
• 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 (Veeva Clinical Vault) daily and completeness of documentation to enable teams to make effective business decisions
• Lead the administrative support of key governing bodies (GRC 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 requirements
• Where required input into functional work including training activities and development of procedures

• Company Sponsored Observational and Interventional Research Projects:
  • Assist the study team with the planning of projects by providing a range of options, risk assessment and local insight that feed into the study feasibility assessment
  • Lead operational set-up and delivery for your area of responsibility; either defined studies or a sub-set of study responsibilities
  • Ensure the development and implementation of study risk mitigation plan and actions for your area of responsibility
  • Manage activities to the agreed KPI’s: time, cost and quality
  • Manage effective collaboration with internal stakeholders such as the Operations Lead (OL), Delivery Director (DD), Epidemiologist/Global Medical Affairs Leader (GMAL) and other internal functions, for example, to assess the impact of project changes on KPI’s.
  • Collaborate with External Service Providers (ESPs) and Clinical Research Organizations (CROs) on the implementation and delivery of studies, ensuring an effective communication plan is implemented and that roles and responsibilities between parties are understood.
  • Monitor the operational aspects of ESP/CRO collaboration within your study remit to ensure they are effectively undertaken and studies are delivered to plan, managing issues and changes to the scope of projects (e.g. time and cost) as they occur.
  • Act as point of contact for AZ Marketing Company (MC) stakeholders, ensuring their commitments are delivered.
  • Report on project status (using Company System such as Veeva Clinical Vault, ACCORD) and participate in project planning and control activities to ensure project plans remain up to date
  • Manage project finance within agreed threshold limits, keeping track of project budget on a continuous basis, maintaining financial management systems (such as ACCORD and OPAL) and ensure transparency with budget holders by obtaining approval for any proposed budget changes.
  • Monitor compliance and ensure reporting of issues as necessary.

•  Externally Sponsored Scientific Research (ESR) Projects:
  • Responsible for the local management and coordination of ESR studies for a given country or region.
  • Acts as a point of contact for MC operational research enquiries, signposting MC to appropriate guidance.
  • Supports the review of ESR proposals to enable a timely, consistent and thorough approach to evaluation e.g. gathering required data from MC, and review committee members such as Patient Safety, Regulatory, Supply chain, Medical etc.
  • Lead the development, baselining and maintenance of project milestones, revising all project planning, in conjunction with MC when necessary, in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met.
  • Leads operational aspects of ESR projects in conjunction with the clinical teams, ensuring compliance with project management guidelines, external regulations and internal processes and policies to enable the delivery of high quality Externally Sponsored Collaborative Research (ESCR)
  • Tracks all project KPI’s from a time, cost and quality perspective, providing progress reports to stakeholders.
  • Identify risks and escalating issues of non-performance and non-compliance to the appropriate person.
  • Maintain quality and accuracy of data within the ESR registry and management tool (Veeva Clinical Vault) on a daily basis and completeness of documentation to enable teams to make effective business decisions.

•  Early Access Programs (EAP)/Named Patient Supplies(NPS):
  • Coordinate the NPS cross functional team interactions, including any ESPs, required for granting Early Access to Investigational Medicinal Products within a defined market, region, institution and/ or therapeutic area(s).

Requirements:

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
•   Demonstrate professionalism and mutual respect
•   Increase efficiency in day to day
•   Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
•   Increase efficiency in day to day tasks
•   Excellent verbal and written communication and presentation skills
•   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 analytical thinking, concern of standards, concern of impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, tenacity conflict resolution skills and the ability to influence others
•   Demonstrate professionalism and mutual respect
•   Willingness and ability to train others on study administration procedures

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.