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Associate Study Manager

Associate Study Manager

ALKUPortland, Maine Metropolitan Area, United States
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Associate Study Monitor

2 years

Start 2 weeks from an offer

On-site with ~25% during the Employee Training period (initial 3-5 months)

~40% at study start-up based on project needs

Background : Our client is a large animal health pharmaceutical manufacturer for companion animal studies. The primary function of the Associate Study Monitor position is to participate in monitoring activities for clinical and non-clinical studies conducted by the Clinical Operations Team. The Associate Study Monitor will work with the Clinical Trials Manager to ensure that studies are conducted in accordance with the scientific design and timelines provided by the Efficacy Technical Lead and in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements / guidelines (e.g., Good Clinical Practice). The Associate Study Monitor will act as the point of contact for their designated clinical study sites and provide regular updates to the Clinical Trial Manager.

Project : Monitoring

  • Monitor study sites to ensure high-quality, compliant study data
  • Serve as the point of contact between Client and study sites
  • Assist with site selection and evaluation
  • Conduct various monitoring activities associated with study initiation, execution, close-out, and submission

Study Coordination

  • Assist the Clinical Trials Manager with study activities including but not limited to review of draft protocols, site budgets and invoicing, monitoring tools
  • Creation, QC, and tracking of study materials e.g. study notebooks, owner folders, central laboratory supplies, etc
  • Assist with maintenance of study master files (electronic and paper) and preparation of the study files for archiving / submission
  • Assist Clinical Trials Manager as needed
  • Data management support

  • Assist in creation and testing of Electronic Data Capture database with optimized edit checks to facilitate monitoring of data
  • Perform data entry, in accordance with the Data Management Plan (where applicable), to ensure a high-quality data set
  • Participate in database cleaning following site close-outs and assist with database lock
  • Perform QC by reviewing entries for accuracy and completeness; resolve discrepancies
  • QC of data, tables, and reports as needed by team
  • Scanning, bookmarking, and QC of documents for submission of study specific data
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    Study Manager • Portland, Maine Metropolitan Area, United States

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