Clinical Data Management Lead
2 weeks ago
Everest Clinical Research Services Inc. is a leading contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device companies worldwide.
We are renowned for our high-quality deliverables, exceptional customer service, and flexibility in meeting client needs. Our global presence spans Markham (Greater Toronto Area), Ontario, Canada; Bridgewater (Greater New York City Area), New Jersey, USA; Shanghai (Pudong Zhangjiang New District), China; and Taipei, Taiwan.
To further our success in the dynamic field of clinical research, we are seeking a highly skilled and customer-focused Clinical Data Manager to join our team. This role can be based either at our Toronto/Markham, Ontario, Canada office or remotely from anywhere in Canada, adhering to our Work From Home policy.
Key Responsibilities:- Plan, manage, control, and execute data processing and management activities for assigned projects, ensuring accuracy, timeliness, and compliance with Sponsor requirements.
- Lead assigned data management projects by applying project management skills, data processing techniques, and coordinating activities to meet deadlines.
- Develop and maintain database validation checks for studies, encompassing both standard modules and therapeutic/drug area-specific requirements.
- Define and monitor clinical trial dataflow and quality control (QC) processes in accordance with corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines. Provide training to site monitors on these processes.
- Design and review Case Report Forms (CRFs) and database schema. Test data capture/entry screens for functionality and accuracy.
- Validate electronically captured data meticulously. Write clear queries for missing data points and those failing pre-defined range checks or logical checks. Contribute to building a standard query library for common modules and therapeutic areas.
- Perform QC procedures on assigned databases during trials and conduct final database closure checks at study completion.
- Train and supervise Data Entry personnel and junior data management staff on study procedures, specific handling protocols, and data management best practices.
- Validate and distribute study progress status reports to internal and external study team members for transparency and informed decision-making.
- Assist in resolving data coding discrepancies related to medical events, treatment procedures, and medications.
- Maintain and prepare final archival documentation for data management activities relevant to assigned clinical trials. Collaborate with the corporate archivist in assembling and archiving clinical trial data and study documentation.
- Cooperate with and assist data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies.
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