Clinical Data Management

Nodway Solutions

Review and understand the study protocol and the timelines.

Perform data review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate.

Implement study team feedback as required on the data.

Perform external checks to handle manual discrepancies and action the same.

Develop specifications, implementation and testing for the edit checks and listings (DVS)

Perform UAT for database

Develop study specific procedures documents

Ensure effective implementation of standard metric and status reporting on the study

Ensure an error free, quality data with no open queries.

Maintain data management study files and documentation

Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor

Identify out of scope tasks and bring to the attention of the TDM

Assist the TDM in all study set up activities.

Provide all study related reports to the TDM as per the request

Perform SAE reconciliation and Vendor data reconciliation

Any other tasks deemed appropriate

o Good understanding of GCP and regulatory requirements related to data management systems and activities

o Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)

o Expertise in end-to-end core clinical data management activities

o Strong understanding of database structures, data standards (CDISC) and practices

o Experience in supporting/building high impact innovation projects specifically in CDM space

Experience : 4 - 10 Years

No. of Openings : 5

Education : Any Bachelor Degree

Role : Clinical Data Management

Industry Type : Call Centre / BPO / KPO / ITES / LPO

Gender : [ Male / Female ]

Job Country : India