Clinical Data Reviewer

6 days ago

Mumbai, India ユニ開発ソフトウェアプライベートリミテッド Full time

Position- Clinical Data Reviewer / Validator- Reporting to- Team Leader or Manager- Qualifications / Work Experience- Formal Education
- Graduate, preferably in science
- Bachelor’s degree / Masters in Life sciences,
- MBBS/BHMS/ BAMS/ BDS/ Paramedical degrees,
- B. Pharm/ M. Pharm
- Bachelors / Masters in Clinical research
Certifications
- Certifications / Diploma in IT &/ CDM
Work Experience
- Previous experience as a Biometrician/ Senior Biometrician 3 - 4 years.- Essential Competencies (Knowledge, Skills and Attributes)- Expected Competency Domain
- Good technical knowledge of medical terminology.
- Compliant with GCP/GCDMP. - Computer and Internet skills and experience (familiarity and comfort with MS Office products). - Understanding database/programming concepts.
- Able to use SQL and other programming/query languages.
- Oral and written English communication skills
- Self-motivated and enthusiastic.
Accountability Domain
- Good technical knowledge of the process of CDMS (e.g. Clintrial, Oracle Clinical).
- Understand and comply with Standard Operating Procedures.
- Anticipate problems, issues, and proactively work to minimize the impact.
- Maintenance of strict confidentiality in all CAC-India projects.
- Responsible for Data Quality.
- Accountable for customer satisfaction of all CAC-India stakeholders.
- Build constructive and effective relationships with study team, departmental associates and others (both inside and outside the company).
- Key Responsibilities:
- Clinical Data Processing
- Verify data in the clinical database using CRFs and DCFs.
- Ensure the completeness and validity of the clinical trial data that has gone through data entry.
- Respond and complete data queries and clarifications identified by the system or through manual checks as identified in the data validation guidelines.
- Propose data clarification forms to clinical trial sites for mentor review.
- Interact with the clients regarding data quality issues.
- Participate in the development of project related documents (e.g. Data Entry guidelines, Data validation guidelines etc.)
- Maintain appropriate validation documentation.
- Investigate and troubleshoot problems and determine solutions.
- Perform other related duties as required.
- Effective communication with study teams and departmental associates.
- Additional Information- Industry type
- Pharma/ Biotech/ Clinical research
Functional Area
- Life science
Experience
- Up to 2 - 4 years of Experience
- Location- Mumbai- Working Hours- As per company policy or depending on Project requirement- Travel- Not Required**Job Code**

**R141**
- E-mail-
- Sub Line- REQ 2019 Q4 R141 Ref: (usindia)

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