Sr Clinical Data Manager
Responsibilities:
- Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close.
- This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks.
- They will ensure optimized data collection, flow and access across EDC and non-EDC data sources.
- They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases.
- The role will operate as a key member of the Clinical Operations team.
- 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.
- 5-7 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.
