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Global Study Associate Director/FTC

AstraZeneca Pharma

  • offer expired 21 days ago
  • contract of employment
  • full-time
  • team manager
  • remote recruitment
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AstraZeneca Pharma

Postępu 14

Mokotów

Warszawa

Your responsibilities

ROLE OVERVIEW

As the study leader, the EDM will usually lead a cross-functional study team made up of Astrazeneca functional representatives and representatives from one of our partner CRO’s. All of our studies are fully outsourced to one of two partners under our EMPOWER outsourcing model. Our partner CRO’s operationalize our studies on our behalf of Astrazeneca - a large component of the role will therefore be overseeing CRO delivery and fulfilling our sponsor oversight obligations.

On occasion, EDM’s may be asked to support other study leaders where the work is particularly complex and workloads high – in such cases it can also be the case that an EDM may be assigned to more than one study at a time. The EDM may also help coordinate the efforts of study team members from Astrazeneca, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).

Finally, the EDM will be expected to support OBU Medical 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.

The main activities an EDM will progress in this setting are:

Project Management

• 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, e.g. 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

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.

Document Development

• Support/coordinate protocol development and finalization

Stakeholder Management

• Support Project team set-up and study sourcing activities

• Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) 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 Associate Director, EDAD).

• Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the Medical stakeholders, local AZ and External Service Providers.

• Coordinate efforts/input of the external scientific community (e.g. (International Coordinating Investigators, Steering/Executive Committee) during project design and delivery

Financial Management

• 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

Our requirements

  • Bachelor’s degree (preferably in medical or biological science) or equivalent by experience.

  • At least 6 years of relevant clinical/medical experience in the pharmaceutical industry, with a good understanding of the drug development process.

  • At least 2 years experience project managing/leading significant packages of activity required to set-up, deliver and report large multi-national globally sponsored studies.

  • Previous demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.

  • Good Project Management knowledge and previous demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.

  • Excellent knowledge of the external regulations e.g. GCP/ICH and Astrazeneca’s SOP’s pertaining to the delivery of interventional and observational studies.

  • Proven ability to work effectively with Clinical Research Organizations/External Providers and 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.

  • Open to periods of travel.

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • sharing the costs of foreign language classes

  • sharing the costs of professional training & courses

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • integration events

  • corporate gym

  • retirement pension plan

  • corporate credit card

  • video games at work

  • coffee / tea

  • drinks

  • parking space for employees

  • leisure zone

  • meal passes

  • sharing the costs of tourist services

  • holiday funds

  • sharing the costs of holidays for kids

  • christmas gifts

  • employee referral program

  • opportunity to obtain permits and licenses

  • charity initiatives

  • extra leave

  • annual bonus

  • glasses reimbursement

  • business travel insurance

  • Work anniversary award

Who we are looking for?

Evidence Delivery Manager (Global Study Associate Director) - 2 roles - permanent/FTC

Oncology Business Unit Medical (OBU Medical) 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.

OBU Medical provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. OBU Medical 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 OBU Medical Evidence Delivery organization is accountable for the operational delivery of medical evidence generating company sponsored studies (Interventional and primary observational) in partnership with our EMPOWER external service providers (Parexel and Labcorp), early access programs (EAPs) in partnership with Clinigen and the oversight of program of externally sponsored research (ESRs).

A vacancy has arisen for 1-2 Evidence Delivery Managers (EDMs) The EDM role is a primarily a study leadership role – similar to the Global Study Associate Director role in Astrazeneca R&D. EDM’s in OBU Medical lead the operational delivery of global clinical studies designed to generate medical evidence to support the use of our medicines.

AstraZeneca Pharma

At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel you're at the frontline of research but your role in changing patients' lives is critical. Our mission is ambitious, and it takes the skills of a collaborative team to really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible.

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