Added
2 hours ago
Type
Full time
Salary
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Related skills

gcp edc ip tmf ec/irb

๐Ÿ“‹ Description

  • Oversee site management to protect patient safety and data quality.
  • Maintain trial management tools and status reports; conduct monitoring.
  • Support site start-up tasks: feasibility, EC/IRB submissions, regulatory docs.
  • Assist budget negotiations and investigator contracts as needed.
  • Verify informed consent and assess factors affecting safety and data integrity.
  • Conduct site visits (pre-study, initiation, monitoring, close-out) per protocol.

๐ŸŽฏ Requirements

  • EU: degree in life sciences or health discipline; NA: equivalent.
  • Excellent communication and organizational skills; team player.
  • Experience with computerized systems (EDC, spreadsheets, email).
  • Ability to travel up to 60%; international travel may be required.
  • Oncology experience preferred for Oncology studies.
  • Experience monitoring EDC trials and EHR records; biopharma exposure.

๐ŸŽ Benefits

  • Discretionary annual bonus.
  • Health insurance.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
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