Sr. Clinical Data Manger

Join to apply for the Sr. Clinical Data Manger role at Katalyst CRO
.

• 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, 21
  
  CFR 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.

• Mid-Senior level

• Contract

• Information Technology

• Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x

Apply BELOW