Study Operations Manager
at Pfizer
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Use Your Power for PurposeReporting to the Research & Development division, you will be integral in bridging evidence-based medical decision support with colleagues and stakeholders to enhance health and treatment outcomes. By developing frameworks to ensure our evidence is scientifically robust, providing unbiased and medically necessary expertise, or investigating data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Your work will support better health outcomes, ensuring that our evidence is sound and that healthcare decisions are informed and safe for patients.What You Will AchieveIn this role, you will:1. STUDY IMPLEMENTATION & MANAGEMENTCollaborate via execution of operational tasks the conduct of studies and projects (Non-Interventional Studies, Low Interventional Studies, etc.) by working with all involved departments and groupsCoordinate and execute operational responsibilities for assigned studies in compliance with Pfizer policies and proceduresSchedule, participate in and take minutes during scheduled team meetings (if required) – distribute minutes, action items, follow-up for completion as neededCreate or assist with study documents as requested by Clinical Scientist or Study Team (MS Word, Excel, Powerpoint)Create folders and file documents in shared drive locations (Sharepoint, Teams, etc) for Study Team to actively manage the projectPrepare and assist others with required internal study documents including, but not limited to, concept submission, due diligence checklist, laboratory worksheets, supply requests, study team rosters, vendor lists, etc.May act as primary contact for vendors, including laboratory and/or Clinical Research Organizations and maintenance of associated documentation (i.e., vendor management plans)Liaise with external vendors to ensure laboratory supplies and sample shipment arrangements are made in accordance with protocol requirements and follow-up with vendor to ensure supply fulfillment is completed as expectedPrepare study/project timelines and track progress against stated milestones and deliverablesTrack Pfizer SOP process steps from concept development through study close-out and ensure Study Team is completing all required items per the relevant SOP and or Medical Affairs processesLiaise with external collaborators, key opinion leaders, to obtain relevant required documentation need in support of various research activitiesManage financial aspects of research projects including, but not limited to, tracking invoicing and payment activities, and alignment with departmental budget forecasts, facilitate execution of Confidentiality Disclosure Agreements, study contract and updatesMaintain study master file and file study documents in the appropriate Pfizer repository (i.e. GDMS, PTMF, etc) Maintain study details in required systems as necessary from concept to close-out (Veeva, SToD, etc)Support audits/inspections as applicable 2. DEPARTMENT LEVEL SUPPORTAssist with entry of study details into any of a variety of systems on behalf of department colleaguesWork with Clinical Scientist team and other operational colleagues on department-wide financial updates and information collection/reportingHere Is What You Need (Minimum Requirements)BA/BS Degree in science, health-related field or epidemiology with at least 5 years of relevant (prior clinical trial, non-interventional study and/or epidemiologic study) experience.Experience with participating in and supporting a multidisciplinary teamExperience in project management - managing fully-outsourced projects or vendor oversight is highly desired for this positionExercises own judgement leveraging knowledge and experience. Works independently with instruction on complex problems.Fluent in English with exceptional written and oral communication and cross-functional collaborative skillsOutstanding organizational skills, managing several projects concurrently that are often time pressured; strong ability to effectively multi-task and prioritizeProficiency in MS Word, Excel, and Powerpoint - additionally helpful to have experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance assigned activities Work Location Assignment: HybridEEO (Equal Employment Opportunity) & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Medical
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