Clinical Data manager

Katalyst CRO; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO in San Francisco is seeking a Clinical Data Manager to oversee data management for trials from startup to database lock. You will lead EDC build, UAT, data cleaning, reconciliation, queries, and database locks while ensuring data accuracy and CDISC compliance.

Collaboration with the Clinical Operations team will drive development of DM documents, CRFs for EDC, data validation, and adherence to GCP and regulatory standards across data sources.

Qualifications

• 5–7 years of data management experience in the pharmaceutical or biotechnology industries.
• Knowledge of industry standards (CDISC, SDTM, CDASH).
• In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.
• Proven ability to preemptively identify data and system issues and mitigate risks to data quality.
• Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.

Responsibilities

• Oversee all aspects of clinical trial data management from study start up through database lock and study close.
• EDC build and UAT, study data cleaning and reconciliation, query issue and resolution, and database locks.
• Ensure optimized data collection, flow and access across EDC and non-EDC data sources.
• Maintain accuracy, consistency, completeness and CDISC compliance of all clinical databases.
• Develop and maintain data management documentation including CRFs, DM plans, edit checks, data review plans and data transfer agreements.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for data review.
• Ensure compliance with GCP, CDISC standards and other regulations.

Skills

Clinical Data Management

Project Management

Stakeholder Management

CDISC Standards

Data Quality Assurance

Education

BSc or MSc in Life Sciences

Tools

EDC Software

MedDRA

WHO Drug

CDISC SDTM/CDASH

Job description

• 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
  

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
  

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 preemptively 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