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17 Algorics Jobs
Clinical Data Associate I / II
Algorics
posted 1d ago
Job Role Insights
Key skills for the job
Job Description
- Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
- May perform data entry for paper-CRF studies, as needed
- May perform quality control of data entry
- May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation
- Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
- Review and query clinical trial data according to the Data Management Plan
- Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Assist with coordinating SAE/AE reconciliation
- Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
- May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
- May present software demonstrations/trainings, department/company training sessions, present at project meetings
- May require some travel
- Perform other duties as assigned
Qualifications:
Minimum Required:
- Bachelors and/or a combination of related experience
Other Required:
- 2+ years experience
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
Employment Type: Full Time, Permanent
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Clinical Data Associate/Senior Clinical Data Associate
1-3 Yrs
Bangalore / Bengaluru
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