Clinical Data Manager II
2 weeks ago
Katalyst Healthcares and Life Sciences is seeking a highly skilled Clinical Data Manager II to join our team.
Job Summary:The Clinical Data Manager II will be responsible for leading data management activities for multiple clinical studies, ensuring timely and quality database lock, and developing and maintaining working practice documents. The successful candidate will have strong experience in data management practices, tools, methodologies, and documentation, as well as excellent communication and organizational skills.
Key Responsibilities:- Lead data management activities for multiple clinical studies, ensuring timely and quality database lock.
- Develop and maintain working practice documents for all Data Management tasks in collaboration with representatives from other functions.
- Act as DM resource to the Clinical Study team and guide the team in the coordination of clinical data review, query generation / resolution and reconciliation activities.
- Support the Director, Clinical Data Management in ensuring the delivery of clinical data in compliance with standard operating procedures, departmental guidelines and regulatory agency guidelines.
- Contribute to the finalization of Protocols for proper data collection including Electronic Case Report Form design.
- Develop and maintain all required data management documentations such as edit check specifications, eCRF Completion Guidelines, Data Management Plans, etc.
- Review eCRFs to ensure alignment with protocol and perform UAT testing to ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
- Proficient in performing data quality checks to clean data for assigned studies. Proactively identify and implement opportunities for process improvement of assigned responsibilities.
- Provide oversight of the DM activities and key DM documentations from CRO(s) and ensure performance aProductst key indicators and the documentation is aligned with best practices and provide DM expertise to study teams.
- Drive and support vendor qualification for data management, define/specify Product of work for functional tasks.
- Support process improvement and knowledge management by participating in or leading task forces/projects
- Demonstrate effective time management skills and able to set priorities to meet timelines. Be able to recognize and schedule changes in response to project demands
- Provide guidance and mentor less experienced Data Management professionals.
- Bachelor's degree in science and/or equivalent work experience in data management field.
- A Minimum of 5+years of working experience in pharmaceutical, biotechnology, medical device/diagnostic or CRO setting with significant hands-on end-to-end experience in clinical data management practices.
- Strong experience leading data management activities for multiple clinical studies, proficient use of data management systems, advanced knowledge of DM processes, tools, methodologies and documentation, solid understanding of DM strategy.
- Strong writing, verbal communication skills, good organizational, time management skills, interpersonal and team skills, and be proactive and accountable.
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