Sr. Clinical Data Manager

Katalyst CRO; Dallas (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Senior Clinical Data Manager. The successful candidate will oversee clinical data management processes, ensuring compliance with regulatory standards. Key tasks include designing case report forms, conducting data validation, and collaborating with study teams to resolve data issues. This role requires a strong background in life sciences and significant experience in data management.

Qualifications

• 7 years of data management experience in pharmaceutical or biotechnology industries.
• Strong expertise in project and program management.
• Knowledge of industry standards including CDISC, SDTM, and CDASH.

Responsibilities

• Develop and maintain data management documentation.
• Design case report forms for electronic data capture systems.
• Conduct data validation checks and implement quality control measures.

Skills

Data Management

Project Management

Stakeholder Management

Regulatory Compliance

Risk Mitigation

Education

BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics

Tools

Web-based EDC

Clinical Data Management Systems

Medical Coding Dictionaries

Job description

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• 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.
  
  

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.
  
  

Requirements:

• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

• Industries

  Pharmaceutical Manufacturing

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