CLINICAL DATA MANAGER JOB RESPONSIBILITIES:
- To co-ordinate between client/any third party contacts within the project on a day to day basis.
- To enter data from case report forms (CRFs) and questionnaires and other project related documents as per data entry conventions of Clinical Data Management.
- To edit the database for correction of data entry errors.
- To perform and supervise CRF design.
- To assist in preparing DM Plan and DM Report.
- To prepare the edit check plan, data entry conventions, self-evident corrections.
- To review and clarify project data in accordance with the edit check plan.
- To carry out query production.
- To edit the database with answers to the data clarification forms (DCFs).
- To develop and validate the programs for comparing double data entry, listing individual data, applying edit checks etc.
- To be involved in development and maintenance of SOPs.
- To file study documentation.
- To implement defined quality control procedures as per DM Plan.
- To record all activities accurately on the company standard timesheet.
MINIMUM QUALIFICATIONS REQUIRED:
- Bachelor’s degree, or educational equivalence, in life science/B. Pharma/ or M. Pharma equivalent combination of education, training and experience.
- 0-1 year relevant experience