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

• Type of Job

  Full Time

• Work Location Type

  Work from Office