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Clinical Safety Data Specialist I
3 months ago
Company Overview:
Everest Clinical Research Services Inc. is a premier contract research organization (CRO) that delivers a comprehensive array of expertise-driven clinical research solutions to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with leading firms and engage with some of the most innovative drugs, biologics, and medical devices currently in development.
Established in 2004, Everest has built a robust foundation as a center of excellence in statistical analysis and data management. Over the years, we have evolved into a full-service CRO, with our headquarters situated in Markham, Ontario, Canada, and additional offices in various international locations.
Renowned for our commitment to quality, exceptional customer service, and adaptability to client needs, Everest is a dynamic organization that continues to thrive and expand.
Position Overview:
We are seeking a dedicated, skilled, and client-oriented individual to fulfill the role of Clinical Safety Data Associate. This position can be performed on-site in Ontario or remotely from a home-based office within Canada, adhering to our Work from Home policy.
Key Responsibilities:
- Formulate safety data review plans for studies and maintain standardized checklists for reviewing clinical trial laboratory data, adverse events (AEs), serious adverse events (SAEs), medical events of special interest, concomitant medications, disease history, and early study terminations due to AEs.
- Conduct safety data reviews in accordance with the established Safety Data Review Plan, ensuring thorough examination of laboratory data, AEs, SAEs, and other relevant medical information. Address and resolve any issues identified during the review process.
- Collaborate with Project Managers and Clinical Data Managers to uphold the integrity of data collected during clinical trials. Document and report any issues promptly and ensure follow-up until resolution.
- Provide medical insights to Clinical Data Managers as needed, particularly in reconciling SAEs.
- Perform coding of AEs, medical histories, and concomitant diseases utilizing the MedDRA dictionary.
- Execute medication coding (including concomitant medications and therapies) using the WHODrug dictionary.
- Work closely with Data Managers to ensure accurate and timely coding of medical events and medications in the study database.
- Engage in the review of trial protocols and Case Report Forms (CRFs) to contribute to the development of precise laboratory data collection methods.
- Assist Clinical Data Managers in drafting Laboratory Edit Specifications, ensuring accuracy and consistency across studies.
- Verify laboratory normal ranges and units from both central and local laboratories, ensuring consistency and accuracy.
- Support Clinical Data Managers in managing laboratory data and resolving related issues.
- Assist the Director of Medical Coding in maintaining version control of coding dictionaries and ensuring compliance with trial Sponsors' requirements.
- Contribute to Clinical Data Management initiatives as needed.
- Provide medical and coding support for programming and biostatistics projects as required.
Qualifications:
- Possession of an RN, M.D., M.Sc., or Ph.D. in Pharmacology or a related health science field, Pharm.D., or equivalent educational background.
- A minimum of two to three years of experience in clinical trial data management, with a focus on medical coding and laboratory data management.
- A comprehensive understanding of clinical trial safety data coding and management.
- Proven ability to manage medical information effectively, with strong communication skills, both verbal and written, across all professional levels. Must demonstrate excellent organizational skills and the ability to work independently while managing multiple projects.
