Manager, Externally Sponsored Research
3 weeks ago
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 Manager, Externally Sponsored Research **oversees performance and ensures process compliance for assigned studies. The Manager, Externally Sponsored Research serves as a liaison between the ESR sponsor site and the AZ study team. The role is responsible for coordinating ESR operational processes across cross functional team members for assigned studies to ensure adherence and timeliness of ESR study execution. The Manager, Externally Sponsored Research is responsible for monitoring performance against contractual commitments and managing ESR management system to reflect most accurate and up to date study information through whole life cycle.
**Responsibilities**:
Acts as the primary local operational contact for all external and internal collaborators for assigned studies
- Provides guidance to external and internal partners on ESR operational processes
- Facilitates local governance meetings including meeting minute documentation, reviews proposals for completeness
- Manages operational compliance with global and local policies, processes, and procedures within assigned tumor type area(s) to ensure timely, cost efficient and high-quality project delivery
- Monitors performance routinely and advancing to obtain necessary approvals for turning point shifts or deviations
- Coordinates effective collaboration and communications between internal collaborators and external partners to enable high quality research projects
- Routinely reviews assigned study performance and escalates when projects are not being managed to time, cost and quality
- For studies that are not on track, ensures corrective action plans are created and documented in ESR study management system and action plans are progressing as planned
- Addresses as a matter of urgency any compliance issues, escalating problems as appropriate
- Ensure timely preparation of research CDAs/CSAs
- Serves as liaison between sponsor site and AZ contracting team
- Collaborates with Regulatory Affairs to requests LOAs to support sponsor regulatory submissions
- Set up and maintain study budget in ESR study management system (e.g., ACCORD as necessary)
- Ensure accurate payments related to the study are reflected in ESR management system in a timely manner
- Accountable for accurate and timely study information into ESR management system ensuring completeness of all essential documentation
- Holds Sponsor accountable to contractual obligations in keeping system updated
**Minimum Requirements**:
- Bachelor’s degree within a scientific or healthcare field or significant and comparable experience
- Experience within the pharmaceutical industry ideally working within a clinical study management and/or Externally Sponsored Research related role
- Experience working in study management systems
- Experience and knowledge of the clinical study and drug development processes and relevant guidelines, e.g., GCP/ICH for a specific therapeutic and geographical area
**Other Skills and Capabilities**:
- Ability to work flexible hours as needed
- Excellent written and verbal English-speaking skills
- Effective relationship building and stakeholder leadership skills across functions, geographical boundaries, and cultures
- Ability to effectively prioritize competing deliverables
- Flexibility and adaptability
- High levels of enthusiasm and energy
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- Top 100 Employers Award
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