Clinical Data Reviewer / Validator Job in Unikaihatsu Software Private Limited
Clinical Data Reviewer / Validator
Unikaihatsu Software Private Limited
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
- Permanent
Job Summary
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.
Candidate having equivalent qualifications, training & experience may be considered.
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.
Receive feedback from HOD, learn from errors and apply corrections.
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.
Guide new candidate to carry out data entry and validation.
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 recruitbpo@usindia.com Sub Line REQ 2019 Q4 R141 Ref: (usindia)
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.
Candidate having equivalent qualifications, training & experience may be considered.
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.
Receive feedback from HOD, learn from errors and apply corrections.
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.
Guide new candidate to carry out data entry and validation.
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 recruitbpo@usindia.com Sub Line REQ 2019 Q4 R141 Ref: (usindia)
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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