Syneos Health logo
Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Report Reviewer

Location

India

Posted

8 days ago

Salary

0

Seniority

Senior

Job Description

Report Reviewer

Syneos Health

• Responsible for execution of Central Report Review activities on the study • May support development of annotated visit reports • Reviews the content and quality of site and central monitoring documentation • Ensure deliverables are provided according to company and/or sponsor specifications • Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary

Job Requirements

  • Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
  • Development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN
  • Reviews the content and quality of site and central monitoring documentation
  • Document requested revisions and approvals in CTMS
  • Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
  • Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
  • Documents observations noted during reviews
  • May assesses CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning
  • Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements

Benefits

  • We are passionate about developing our people, through career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program
  • We are committed to building an inclusive culture – where you can authentically be yourself

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