Medical Data Safety Associate
7 days ago
Company Overview
Everest Clinical Research is a leading contract research organization providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide.
Job Description
We are seeking a highly skilled Medical Data Safety Associate to join our team in Toronto/Markham, Ontario, Canada or remotely from a home-based office in Canada.
Key Responsibilities:
- Develop and maintain standard safety data review checklists for clinical trial laboratory data, adverse events (AEs), serious AEs, medical events of special interest, concomitant medications, disease history, and early study termination due to AEs.
- Perform safety data reviews according to the Safety Data Review Plan and ensure accurate coding of AEs/medical histories/concomitant diseases using the MedDRA dictionary and medications using the WHODrug dictionary.
- Collaborate with Project Managers and Clinical Data Managers to ensure high-quality data collection in clinical trials and document, report, and follow up on issues identified during the review in a timely manner.
- Provide medical advice to Clinical Data Managers for SAE reconciliation and participate in trial protocol review and CRF/eCRF review to ensure accurate and consistent approaches in laboratory data collection.
- Coordinate with Data Managers to ensure medical events and medications collected in study databases are coded accurately and on a timely basis and assist in managing local and central laboratory data.
- Participate in Clinical Data Management initiatives and provide medical and coding support for programming and biostatistics activities as required.
Qualifications and Experience:
- RN, M.D., M.Sc., or Ph.D. in Pharmacology or health-related science, Pharm.D., or equivalent education in relevant disciplines.
- 2-3 years' experience in clinical trial data management, including medical coding and laboratory data management.
- Strong knowledge of clinical trial safety data coding and management, effective communication skills, and ability to work independently and manage multiple projects/tasks.
We Offer:
At Everest Clinical Research, we value diversity, equality, and inclusion and welcome applications from individuals with disabilities. We offer a collaborative and dynamic work environment that fosters professional growth and development.
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