US Medical Affairs Oncology - Externally Sponsored Research Manager

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 researchperformed in the USA,aligning tofranchise priorities to deliverhighquality, compliant studies that inform practice and broaden patient impact. You will partnercrossfunctionallyto leadendtoendstartup and execution with franchise teams and sites: triaging proposals, coordinating governance, guiding ESR processes, and ensuring contracts, budgets, and systems areaccurateand 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 patientsbenefitfrom our medicines, we invite you to apply!

Job 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 ensuretimely, cost efficient and high-quality project delivery. Address urgently compliance issues, advancing problems as appropriate

• Accountable foraccurateandtimelystudy 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 localstrategic alignment (LSA)governance meetings(includingbut not limited to coordination of meetings,meeting minute documentation, reviews proposals for completeness, outcome sharing and follow-up)

• Ensuretimelypreparation of research CDAs/CSAs

• Routinely review assigned study performance and escalate when projects are not beingmanaged to time, cost and quality to franchises, projectmanagersand finance teams.

• Set up andmaintainstudy budgetcurrent and up to datein ESR study management system (e.g., ACCORD as necessary).Ensureaccuratepayments related to the study are reflected in ESR management systemin a timely manner

• Maintainall data in VCV system up to date, ensuring that portfolio is updated ina timelyfashion,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 areprogressing as planned

• For USMA funded ESRs, support franchises on quarterly ESR analysis, risk mitigationdocumentingand follow-up

• Collaborates with Regulatory Affairs to requests LOAs to support sponsor regulatory submissions

• Hold Sponsor accountable to contractual obligations in keeping system updated

Education, Qualifications and ExperienceMinimum 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 studymanagement

Other Skills and Capabilities:

• Effective relationship building and stakeholder management skills across functions

• Ability to effectively prioritize competing deliverables

• Flexibility and adaptability

• High levelsof enthusiasm and energy

The annual base salary for this position ranges from $112,154-$168,231. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). 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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.