Associate Director, Evidence Project Management

5 months ago

Mississauga, Canada AstraZeneca Full time

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**The Medical Evidence Delivery Team within Oncology Business Unit (OBU)** is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored scientific research (ESR) and early access programs (EAP) in order to generate the evidence to build confidence in and provide access to AstraZeneca therapies for patients in need.

**Associate Director, Evidence Project Management (AD EPM) **will lead the operational planning, delivery, oversight and budget management of company sponsored evidence studies and/or EAPs within the assigned therapeutic area (TA). This person is responsible for leading a cross-functional AstraZeneca (AZ) study team and supervising the CRO study team as well as for providing the teams with direction and guidance to enable successful study and/or EAP delivery. The AD EPM is the main liaison between the AZ and CRO teams and is accountable for the delivery of a study and/or EAP according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and external partners.
This person will also lead the study and/or EAP team in accordance with the clinical outsourcing model (i.e. EMPOWER, early access principles), current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and standard processes and in line with AZ values and behaviours.

In addition, they will support OBU Medical Evidence’s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for standard process, and contributing to the development and maintenance of guidance documents and training materials.
Associate Directors, Evidence Project Management II are the group of most experienced AD EPMs who will serve their less experienced colleagues as mentors. They pose the ability to handle an increased complexity, to lead departmental initiatives and to stretch up as needed.

**Responsibilities**:

- Partner with direct manager, ensuring provision of expertise and operational input into the programs (e.g. IMAP, ERT, MARCO, SDC, CSP)
- Collaborate with Dir EPM /Sr Dir EPM and provide adequate input to enable effective CRO selection
- Work with externally managed/outsourced partners for studies planning and delivery
- Serve as the reference point for communication and escalation of issues
- Mentor, coach and support the study team members.
- Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of breakthroughs.
- Be primary AZ point of contact for the CRO Project Manager to secure study delivery according to set criteria.
- Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the study lifecycle in alignment with relevant AZ SOPs and guidelines (e.g. Sponsor Oversight Plan, Description of Services)
- Co-ordinate/lead timely contributions of AZ core/extended members
- Collaborate with key partners cross-functionally, and/or external partners, to identify, handle and resolve issues affecting study delivery
- Review protocol drafts and input operational perspectives/content into document and authoring team discussions
- Provide input into and/or quality review and hold accountability for the development of crucial study level documents (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
- Ensure all required External Service Providers (e.g. CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
- Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EP

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