Related skills
edc ip tmf ich-gcp crf๐ Description
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- Oversee site management to protect patient safety and data quality. \n
- Guide audit readiness and support for audits and follow-ups. \n
- Manage site start-up activities, EC/IRB submissions, and regulatory docs. \n
- Conduct on-site and remote monitoring with timely reports. \n
- Maintain trial tools and ISF/TMF reconciliation and archives. \n
- Travel up to 60% and coordinate investigator meetings. \n
๐ฏ Requirements
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- University degree in life sciences/pharmacy or healthcare; or licensed professional. \n
- Excellent communication and organizational skills; team player. \n
- Experience with computerized systems, spreadsheets, word processing, email. \n
- Ability to travel up to 60% and international travel as needed. \n
- Fluency in English; local language for non-English countries. \n
- Oncology or Cardiology monitoring experience; EDC trials preferred. \n
๐ Benefits
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- Paid time off and volunteer time off \n
- Comprehensive medical benefits \n
- Non-vested 401(k) with company match \n
- Paid parental leave \n
- Growth and professional development opportunities \n
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