Clinical Data Specialist

3 weeks ago


Hyderabad, India Lifelancer Full time

About TheRole

Yourresponsibilities include but are not limitedto:

Contribute to electronic CaseReport Form (eCRF) development with a thorough understanding ofdata to be collected and in alignment with theprotocol.

Support the assessment of new datacollection requirements in assigned studies and provide clinicalinput into the development of new and updated clinical DataStandards (for CRFs as well as 3rd party data collectionmethodologies) for assigned trials/therapy areas asneeded.

Provide timely information for andsupport the setup and finalization of accurate and highquality DataTransfer Specification (DTS) documents.

Helpdefine a timely transfer schedule for rapid data availability andreview. Act as facilitator / problem solver between all partiesinvolved (e.g. clinical functions data operations vendors) tostreamline and accelerate DTS finalization andrevision.

Provide expert input into the DataQuality Plan (DQP) with a focus on clinical checks (e.g. usingstandard library checks and accounting for studyspecific needs) anddata risks.

Conduct regular Clinical DataReviews (CDR) in consultation with the Clinical Data Analyst andclinical team (e.g. routine review for DB lock Interim AnalysisSnapshots etc) and according to the DQP utilizing visual outputslistings and other outputs as appropriate.

LeadCDR meetings keep track and file CDR meetings outcomes and actions.Raise and resolve queries related to CDR in the clinical database.Highlight any significant risk trend data discrepancies processdeviations at Data Quality Team (DQT) meetings.

Identify track and resolve Protocol Deviations (PDs) as perNovartis processes. Detect potential PDs based on regular clinicaldata review evaluate nonimportant PDs ensure medical review asneeded file monthly PD listing detect trends and take actions asrequired.

Diversity Inclusion /EEO

We are committed to building an outstandinginclusive work environment and diverse teams representative of thepatients and communities weserve.

RoleRequirements

  • 34 yearsrelevant experience Clinical Trial Design
  • 34years relevant Data Review Reporting
  • Diverseeducational backgrounds including scientists with various LifeSciences backgrounds and Health Care Professionals such asPharmacists Nurses Medical doctors orDentists.
  • relevant experience in areas such asClinical Data Review
  • relevant experience inClinical Data Management
  • relevant experiencein Pharmacovigilance
  • relevant experience inClinical Project Management.

Pleaseuse the below link for job application and quickerresponse.

RemoteWork :

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