Note: The job is a remote job and is open to candidates in USA. Infosoft, Inc. is a global medical device manufacturer seeking a Clinical Data Management Analyst. The role involves creating metrics to identify trends in clinical data, managing data collection processes, and supporting clinical data management activities.
Responsibilities
- Evaluate data errors and collection issues; provide guidance and recommendations to the clinical team for resolution
- Define and specify clinically 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 online, including conducting project team meetings, establishing and maintaining project timelines, and communicating with 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 database
- Participate in the 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
- Works closely with internal Data Management supporting all data management activities for studies (to include database setup, CRF design and validation, edit checks, ongoing data review, data reconciliation, critical data review, document archival, Data lock activities etc
- Reports status, provides metrics to in-house Data Manager, interacts with data management personnel on assigned activities and deliverables
- Reviews full study subjects for completeness and data accuracy
Skills
- Bachelor's Degree or equivalent
- 2-4 years of experience required
- Hands-on experience with Medidata Rave
- Data review experience
- Query management experience
- Experience in creating Rave reports
- Experience with Rave Architect for creating eCRF forms
- Excel
- Good computer skills in the 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. will be considered
Benefits
- Hybrid for local candidates – 3 days onsite, 2 days remote preferred
- Remote considered as a second preference
Company Overview