Related skills
gcp edc ip tmf ec/irb๐ 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.
๐ฏ 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.
๐ 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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