US Medical Affairs Oncology - Externally Sponsored Research Manager

AstraZeneca • Gaithersburg, MD

1d

About The Position

Join us to advance evidence that improves patient outcomes in partnership with our US Medical oncology teams. As an ESR Manager, you will serve as the operational backbone for externally sponsored research performed in the USA , aligning to franchise priorities to deliver high quality , compliant studies that inform practice and broaden patient impact. You will partner cross functionally to lead end to end start up and execution with franchise teams and sites: triaging proposals, coordinating governance, guiding ESR processes, and ensuring contracts, budgets, and systems are accurate and current. You will keep programs on time, on budget, and inspection-ready by driving proactive risk mitigation, timely resolution of blocking issues, and clean data across ESR platforms. If you thrive in a collaborative environment and want your work to help more patients benefit from our medicines, we invite you to apply!

Requirements

• Minimum Requirements: Bachelor’s degree
• 0-1 yr 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 the USA.
• Financial knowledge on study management

Nice To Haves

• Effective relationship building and stakeholder management skills across functions
• Ability to effectively prioritize competing deliverables
• Flexibility and adaptability
• High levels of enthusiasm and energy

Responsibilities

• Act as the primary local operational contact and liaison for all external sponsor sites and internal cross-functional collaborators for assigned studies. These collaborators include AZ contracting, US Franchises, GMA, and finance.
• Coordinate effective collaboration and communications between internal collaborators and external partners to enable high quality research projects
• Provides mentorship to external and internal collaborators on ESR operational processes
• Manage 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 . Address urgently compliance issues, advancing problems as appropriate
• Accountable for accurate and timely study information into ESR management system , and to cross-functional stakeholders (Franchise teams, Finance, Project Managers, etc ) ensuring completeness of all information and documentation is complete
• Facilitate local strategic alignment (LSA) governance meetings ( including but not limited to coordination of meetings, meeting minute documentation, reviews proposals for completeness , outcome sharing and follow-up)
• Ensure timely preparation of research CDAs/CSAs
• Routinely review assigned study performance and escalate when projects are not being managed to time, cost and quality to franchises, project managers and finance teams.
• Set up and maintain study budget current and up to date 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
• Maintain all data in VCV system up to date, ensuring that portfolio is updated in a tim e ly fashion , at a minimum once per quarter
• For studies that are not on track, in collaboration with AZ sponsor, ensures corrective action plans are created and documented in ESR study management system and action plans are progressing as planned
• For USMA funded ESRs, support franchises on quarterly ESR analysis, risk mitigation documenting and follow-up
• Collaborates with Regulatory Affairs to requests LOAs to support sponsor regulatory submissions
• Hold Sponsor accountable to contractual obligations in keeping system updated

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level