AIXIAL an ALTEN company (International CRO) is hiring for Clinical Data Manager

AIXIAL an ALTEN company (International CRO) is hiring for Clinical Data Manager

21 April, 2022

 AIXIAL an ALTEN company (International CRO) is hiring for Clinical Data Manager

Experience: 2-5 years of experience in Pune, India.


Interested candidates can share their resume at shruti.kava@aixial.com

About the job

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Germany, Czech Republic and India.

Due to fast growth of our company we are currently recruiting a colleague for the position of an Clinical Data Manager, the position would be based in Pune.

As part of the data management of clinical, epidemiological and observational studies:

1. Ensures ICH GCP regulations and SOPs are adhered to for data management activities.

2. Maintains full understanding of protocol including study documentation.

3. Writing eCRF specifications.

4. Drafting eCRF completion guidelines

5. Preparing Data Transfer Agreement for Vendor.

6. Writing DVP specifications and Test steps.

7. performing unit acceptance testing

8. Performing discrepancy management in accordance with the agreed timelines.

9. Escalate any discrepancy in the clinical data to senior data manager.

10. Identifying issues with validation procedures during study conduct and communicates

findings to senior data manager.

11. Point of contact to monitors for data flow, discrepancy Management, and all other data

management related processes.

12. Communicating site data issues (dataflow, discrepancies, etc.) with senior data manager,

and Monitors (if required).

13. Performing SAE reconciliation.

14. Performing Vendor data reconciliation

15. Executing data listings programs and dataset reviews for patient data consistency, quality

and completeness.

16. Perform discrepancy management on front end checks and the programmed consistency

checks(back end)

17. Utilization of appropriate data management tools to monitor quality and timeliness of data flow for assigned sites

18. To ensure error free, quality data with no open queries prior to database lock.

19. Coordinates with the senior data manager with respect to any unresolved queries and close the same.

20. Performing Data base lock and freezing.

21. Coordinate with coding team for coding related activities.

22. Supporting CDM in developing Study Metrics and Study Status Reporting.

Secondary Responsibilities:

1. Develops and maintains effective working relationships with the senior Data Manager.

2. Timely and quality deliverable for senior data manager review.

3. Responsible for all set up deliverables to senior data manager.

4. Attend relevant study teleconference with the client.

5. Participate in the functional training and mentoring of new Associates joining the team.

Minimum Requirements :

  • Bachelors or Master’s degree in Science.
  • 2-5 years of experience in clinical data management.
  • Analytical and adaptability skills
  • Able to work in a team.

Computer Skills :

  • MS office (word, PowerPoint, excel…etc.)

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