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Asepsa2025

Asepsa Outsourcing 

Study Operations Manager​​

MAIN REPONSIBILITIES / DUTIES ​

  • Support via execution of operational tasks the conduct of studies and projects (Non-Interventional Studies, Low Interventional Studies, Research Collaborations, etc.) by working collaboratively with all involved departments and groups​
  • Coordinate and execute operational responsibilities for assigned studies in compliance with Pfizer policies and procedures​
  • Schedule, participate in and take minutes during scheduled team meetings (if required) – distribute minutes, action items, follow-up for completion as needed ​
  • Create 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 Project​
  • Prepare 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 expected ​
  • Prepare study/project timelines and track progress against stated milestones and deliverables.​
  • Track 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 processes​
  • Liaise with external collaborators, key opinion leaders, to obtain relevant required documentation need in support of various research activities ​
  • Manage 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 updates​
  • Maintain 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 (Siebel, SToD, etc)​
  • Support audits/inspections as applicable ​

REQUIRED SKILL SET​

  • BA/BS Degree in science, health-related field or epidemiology, or relevant experience is required ​
  • Minimum of 5 years of relevant (prior clinical trial, non-interventional study and/or epidemiologic study) experience is required; ​
  • Experience with participating in and supporting a multidisciplinary team​
  • Experience in project management – managing fully-outsourced projects or vendor oversight is highly desired for this position​
  • Exercises 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 skills​

Aplicar para este puesto

Envía tu currículo a la dirección de correo: reclutamiento-asepsa@pfizer.com

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Created by Alex Volkov