Clinical Data Coordinator
3 weeks ago
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 non-serious 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 study-specific protocols.
**Job Types**: Full-time, Fresher
**Salary**: ₹418,079.77 - ₹1,027,115.65 per year
**Benefits**:
- Cell phone reimbursement
- Health insurance
Schedule:
- Day shift
- Fixed shift
- Monday to Friday
Supplemental pay types:
- Performance bonus
- Shift allowance
Ability to commute/relocate:
- Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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