Clinical Data Coordinator - Mumbai, India - Refined Reports Data

Refined Reports Data

Verified Company

Mumbai, India

3 days ago

Posted by:

Deepika Kaur

beBee Recuiter

Administer the execution of QC evaluation for data enter into the CTMS that lead to senior management exceeding client deliverable expectations.

Follow GCP and ICH within guidelines.
Attend and participate in CRO meetings.
Act as CDM resource person for internal teams.
Mentore outsourced colleagues at global CRO regarding study processes.
Develop and maintain good communications and working relationships with CDM team.
Collect and review all documentation to be file in to the TMF.
Review and prepare nonserious adverse events and serious adverse events reports for FDA submission.
Work with the programming team in creating the SAS scripts to extract reports from the SQL developer.
Programme statistical tables and listings in SAS for reporting, and provide quality control and validation of data.
Conduct and coordinate QC activity and medical coding.
Lead on international studies in respiratory and oncology studies.
Participate in CRF development per data capture requirements per protocol.
Direct enrollment and evaluation of patients in adherence with studyspecific protocols.