Medical Evidence Manager/lead

6 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.

**Responsibilities**:

- Plan and deliver observational research and Real World Evidence (RWE) studies in AstraZeneca Canada’s Biopharmaceuticals therapy areas, with a focus in Oncology therapy areas (hematology and GI). Additional cross-therapy area, including public health, experience would be an asset
- Lead the development and execution of comprehensive impactful and practice-changing evidence plans for both pre-launch and launched products to address full breadth of internal and external partner needs
- Identify and collaborate with key external experts to address identified evidence gaps, including academic-clinical investigators, health outcomes researchers and contract research organizations (CROs)
- Work collaboratively with Medical Advisors and Market Access colleagues to develop AstraZeneca-sponsored study protocols for local observational (both prospective and retrospective) studies, as well as review and advise on externally sponsored research proposals
- Identify and evaluate new health database and disease registry opportunities in Canada that could be used for real world studies in therapy areas of interest
- Liaise with global counterparts for all evidence generating activities and lead the review and approval process for local studies at AstraZeneca Canada
- Drive local and global study teams in order to deliver project-specific achievements and resulting scientific publications (e.g., conference presentations, peer-reviewed journal manuscripts) according to timelines (e.g., HTA submission target)
- Develop and manage communication and knowledge translation plan for all evidence generating activities to ensure the full impact of the evidence can be embedded in strategic decisions
- Lead site start-up activities such as ethics submission, informed consent review, development and finalization of research study agreements and follow-up and maintenance of all study related activities, if required, in accordance with AstraZeneca and international regulatory requirements.
- Develop and maintain study budget, timelines and resources and ensure appropriate updates are made to internal tracking systems
- Prepare, implement, track, collect, review and assess study documents and ensure their completeness according to external guidelines and AstraZeneca SOPs
- Complete study feasibilities for Global Non-Interventional Studies in collaboration with the local team and global counterparts
- Provide in-house epidemiology, statistics, and observational research methodology expertise to cross-functional partners, including Medical, Market Access and Regulatory teams

**Qualifications**:

- Master’s degree or PhD in epidemiology, health research methodology, biostatistics and/or data analytics required).
- Understanding of statistical principles and methodologies applicable to observational and other types of real-world studies (eg pragmatic trial design)
- Experience in data analytics and/or ability to work with different health databases an asset
- Excellent understanding of observational study methodology (design and interpretation) and externally sponsored research including clinical and pre-clinical research
- Demonstrated track record in observational research, demonstrating both strategic and tactical elements
- Demonstrated leadership ability in a team environment
- Experience in project management
- Excellent interpersonal, verbal and written communication skills
- Self-motivated and able to display autonomy and initiative - for instance; able to take action, move actions forward and make decisions without the need for continual supervision or consultation.
- Ability to interact with key external customers, including governments, payers, academic researchers and physicians
- Effective time management skills
- Good knowledge of MS Office (Word, Excel, PowerPoint)
- Knowledge of French is an asset
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