Note: The job is a remote job and is open to candidates in USA. TalentBurst, an Inc 5000 company, is seeking a Sr Analyst for Clinical Data Management to join their team. The role involves creating metrics to identify trends in clinical data, providing recommendations for data status improvement, and managing project activities related to clinical studies.
Responsibilities
- Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
- Define and specify clinical data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected
- Lead project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders
- Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations (10%)
- Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access the database
- Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training
Skills
- Bachelor's Degree or equivalent
- 2-4 years of relevant experience required
- Experience with Medidata Rave is required
- Experience with EDC (Electronic Data Capture) systems required
- Good computer skills in Microsoft Office Suite
- Good written and verbal communication skills and interpersonal relationship skills
- Good problem-solving and critical thinking skills
- Local candidates are preferred, with a hybrid work schedule of 3 days on-site and 2 days remote/WFH
- Qualified remote candidates within the U.S. can be considered
Benefits
- Competitive compensation
- Comprehensive benefits, including medical, dental, vision, and retirement options
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