Sr. Clinical Data Manager
Sr. Clinical Data Manager
Posted on :
18-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Develop and maintain all data management documentation including case report forms data management plans edit check specifications data review plans and data transfer agreements.
- Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection.
- Perform data entry and cleaning activities including discrepancy management and query resolution.
- Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
- Collaborate with study team members to resolve data-related issues and discrepancies.
- Generate and review data listings summaries and reports for data review
- Serve as a primary or backup resource for issues about data management.
- Ensure compliance with guidelines Good Clinical Practice (GCP) CDISC standards and other relevant regulations.
- Contribute to the development and validation of data management software tools.
- BSc or MSc in Life Sciences Data/Computer Science Bioinformatics or equivalent industry experience.
- 7 years of data management experience in the pharmaceutical or biotechnology industries.
- Strong expertise in project/program management including stakeholder management.
- Knowledge of industry standards (CDISC SDTM CDASH).
- In-depth understanding of Data Management regulatory guidelines: ICH GCDMP 21CFR Part 11.
- Proven ability to pre-emptively identify data and system issues and mitigate risks to data quality.
- Knowledge and experience with development validation execution maintenance documentation and archival of clinical data.
- Experience in development and implementation of Clinical data management standards and procedures.
- Experience with web-based EDC clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
Employment Type
Full Time
Key Skills
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