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