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Job ID : 205614BR
Position Title : Clinical Data Manager
Division : Global Drug Development
Business Unit : GDO GDD
Work Location : Hyderabad
Functional Area : Research & Development
Job Description :
- Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.
- 1. Provide professional DM input on Clinical Trial Team(s)
- 2. Input to and review of clinical trial database design including User Acceptance Testing (UAT).
- 3. Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
- 4. Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.
- 5. Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
- 6. Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
- 7. Support and provide leadership for data management staff for allocated trials.
- 8. Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
- 9. Perform training on data management software and practices or trial specific topics as required.
- 10. Prepare training materials for data management activities and processes as required.
- 11. Travel is required as needed.
Minimum Requirements –
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant de-gree. Fluent English (oral and written).
- 1. Two or more years experience in drug development with at least 2 years experience in Data Manage-ment.
- 2. University Science Degree in life sciences, phar-macy, nursing or equivalent relevant experience.
- 3. Excellent written and oral English skills
- 4. Understanding of clinical trial methodology, GCP and medical terminology
- 5. Good computer skills
- 6. Good organizational and project management skills.
- 7. Good communication and interpersonal skills
- 8. Intermediate presentation and problem solving skills
- 9. Ability to work well in a team
- 10. May coordinate and provide direction on task to other data management team members.members.