Medical Data Review Specialist
5 days ago
Caidya is seeking an experienced Medical Data Reviewer to join our team. As a key member of our clinical trials unit, you will be responsible for performing medical data review tasks to ensure compliance with applicable SOPs/Guidelines, Sponsor/Client directives, and GCP guidelines.
About the Role
This exciting opportunity allows you to work on various projects, collaborating with cross-functional teams to execute medical data review functions effectively. Your expertise in medical data review using visual analytics programs will be invaluable in this role.
Key Responsibilities
- Perform medical data review tasks, including but not limited to:
• Reviewing vital signs, physical examination results, laboratory tests, ECG results, imaging results, adverse events, and concomitant medications
• Implementing medical data review tools, including listings, patient profiles, and visual analytic templates
• Generating, reviewing, and inputting into the review/closure of medical queries
• Preparing project-specific reports and training new team members in medical data review processes
Requirements
To succeed in this role, you should possess:
- A Physician Assistant, Nurse Practitioner, or MD degree (or country-specific equivalent)
- At least 1 year of clinical experience post-degree and 2 years of experience in the Pharmaceutical, Biotech, Medical Device, and/or CRO industry working with clinical data
- Strong knowledge of ICH GCP, applicable regulatory requirements for study data, good documentation practices, and clinical databases
- Excellent time management, prioritization skills, and attention to detail
Benefits
We offer a competitive salary, commensurate with experience, estimated at $80,000 - $110,000 per annum, depending on location and qualifications. Benefits include opportunities for professional growth and development within our dynamic organization.
Contact Information
Please note that we do not accept applications via email or phone calls. If your skills and experience align with this opportunity, please submit your application through our online portal.
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