Evidence Delivery Associate Director - Mississauga, Canada - AstraZeneca

AstraZeneca

Verified Company

Mississauga, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Business Area:

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.

About the role:

Evidence Delivery Associate Directors (
EDAD) will lead or support the operational planning, delivery, oversight and budget management of company and/or externally 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.

In addition, the EDAD will support BPM Evidence's continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and

maintenance of guidance documents and training materials.

Usually, the EDAD's focus will be on one of the three main types of work as described below.

Roles & Responsibilities:

Company Sponsored Observational and Interventional Research:

Company sponsored observational and interventional research
Support/coordinate protocol development and finalization
Manage 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 escalations with ESPs/CROs
Stakeholder Management
Support Project team setup 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 transparency 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 P
roject 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 inspectionreadiness
Support implementation of studyrelated 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

Externally
Sponsored Scientific Research (ESR):

Manage across a range of global and local cross-functional stakeholders to ensure all AZ obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met

Manage external stakeholder, e.g. external Investigator and Sponsoring institutions
Support ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitate awareness and understanding of ESR budg