About the role:
BioPharmaceuticals Medical (
BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on 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 AstraZeneca 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.
Evidence Delivery Associate Directors (
EDAD) will lead or support the operational planning, delivery, oversight and budget management of company sponsored research. They may also help coordinate the efforts of extended team members, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). The EDAD may own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.
Role & Responsibilities:
- Support/coordinate protocol development and finalization
- Handle Study Governance (post SDC)
- Support/coordinate all internal, study governance processes (e.g. ERT, MARC, LSPC, Clinical Challenge)
- External Service Provider Management
- Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
- Support strategic handover meetings and kick off meetings
- Perform CRO oversight to help ensure project delivery within time, cost and quality
- Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and that they have clear remits for delivery
- Manage study specific issues and concerns with ESPs/CROs
- Stakeholder Management
- Support Project team set-up and study sourcing activities
- Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Global Medical Affairs Leader (GMAL) respectively, as well as other internal cross functional global roles
- Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Delivery Director(EDD))
- Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, local AZ and External Service Providers
- Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery
- Manage study finance:
- If leading a study, develop and maintain the overall study budget (internal and external study costs)
- Ensure clarity over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes
- Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO
- Manage and reconcile Contracts, POs and invoices
- Support financial audit readiness and Sox attestation as needed
Other Project Management activities as applicable:
- Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to AstraZeneca quality standards
- Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness
- Support implementation of study-related change management within business strategy, s.a. assessment of scope changes
- Ensure Compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches
- Undertake feasibility assessments with internal and external stakeholders
- Manage study systems reporting
- Management of study Governance processes
- Management of internal and external stakeholders
- Finance Management support
- Project Management of owned study areas to deliver according to cost, time and quality
- Support of study Risk Management and Quality Management activities
- Study compliance
- Note additional accountabilities around finance management and team resource management may be relevant when assuming a study leadership role*
Requirements:
- Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
- Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
- Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
- Scientific awareness and extensive knowledge of observational study guidelines and SOPs
- Extensive knowledge of early and late stage Pharmaceutical Development
- Ability to effectively work with Clinical Research Organisations/External Providers.
- Proven ability to interact widely and effectively within the company across regions, functions and cultures.
- Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
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Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
