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    Associate Manager I, Quality - Mississauga, ON, Canada - AstraZeneca

    AstraZeneca
    AstraZeneca Mississauga, ON, Canada

    3 weeks ago

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    Description

    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.


    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.

    Manage Study Governance (post SDC)

    External Service Provider Management

    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 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:
    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

    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. Ensure Compliance with AZ Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches

    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.) Manage external stakeholder, e.g. external Investigator and Sponsoring institutions

    Provide oversight to local Marketing Companies (MC's) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate

    Lead and manage aspects of the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research projects

    Acts as the first point of contact for local MC operational enquiries

    Tracks all ESR study time, cost and quality KPIs, taking corrective action as required. Ensure operational quality and compliance with policies and procedures for ESRs globally

    Leads aspects of the planning, implementation and delivery of EA programmes

    Perform vendor oversight to ensure EA Program delivery to time, cost and quality

    Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery

    Manage triaging of program specific issues and escalations with internal (e.g. Global Clinical Leads, Chief Medical Office, supply chain representatives) and external stakeholders

    Manage the review process of NPS requests to ensure timelines for decision making are adhered to, utilising appropriate Company systems, so that a decision on the request can be returned to the patient's physician

    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

    Experience and knowledge within compliant management of Externally Sponsored Scientific Research

    Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment


    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 .

    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.

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