Sr. Clinical Data Manager

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.

Requirements:

• 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.