AddressA. Create, maintain and update study specific documents like Data Management Plan, Creation of Data Validation Plan, study specific procedures, data reconciliation plan and other study specific documents.
B. Designing Case Report Forms for paper and EDC studies and reviewing CRFs design.
C. Perform data entry in the database whenever required.
D. Co-ordinate with other study team members for data management related tasks on study activity.
E. Creating and Testing of UAT data in study database based on the edit checks created to maintain data integrity at the time of project deliverable.
F. Check consistency of Data Entry screens with case report form.
A. Train the clinical sites on using the study specific database for Electronic Data Capture (EDC) studies.
B. Identify and resolve data discrepancies in Clinical Data via computerized and manual data checks.
C. Perform the Quality Review of live data.
D. Apply level 1 correction to the database as and when required.
E. Generate queries, Update and Verify the received DCFs and Ex-DCFs.
F. Handle the external data and perform the applicable external data reconciliation process and resolve queries pertaining to the external data.
G. Perform Serious Adverse Event (SAE) Reconciliation and resolve queries pertaining to the SAEs.
H. Perform Medical Coding of terms reported on Case Report Form.
I. Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality.
J. Maintain documentation of training as appropriate.
K. Work with other members of the project team. This includes but is not limited to External team, Programmer, Statistician, Monitor and CRA.
L. Conforms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements.
Job Types: Full-time, Permanent
Salary: ₹236,393.70 - ₹733,360.26 per year
Benefits:
- Health insurance
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Application Question(s):
- This opening is for Ahmedabad Location will you be able to relocate to Ahmedabad if selected
- On which phases you have worked on in CDM
Education:
- Bachelor's (Preferred)
Experience:
- total work: 1 year (Required)
Work Location: In person
