- Company Name
- Katalyst CRO
- Job Title
- Clinical Data Manager
- Job Description
-
**Job Title**
Clinical Data Manager
**Role Summary**
Lead the design, execution, and oversight of data management for multiple clinical trials. Ensure accurate, compliant data collection and delivery, align with CDISC standards, regulatory requirements (FDA, ICH GCP, HIPAA), and support statistical analysis and regulatory submissions.
**Expectations**
- Manage multiple studies concurrently with strict timelines
- Maintain data integrity and regulatory compliance
- Mentor and supervise junior or contract staff
- Collaborate with clinical teams and external parties
- Deliver high‑quality datasets to statisticians and regulatory bodies
**Key Responsibilities**
- Design and implement EDC systems, CRFs, and databases per protocol and CDISC guidelines
- Supervise data entry, validation, reconciliation, and audit trails
- Review source documents and CRFs for completeness, consistency, and GCP compliance
- Monitor patient data capture (vitals, blood sampling, lab results, EMR integration)
- Ensure HIPAA confidentiality and data protection across all processes
- Prepare datasets for statistical review using SAS, R, or equivalent tools
- Manage documentation workflows, protocol amendments, and regulatory submissions
- Mentor junior team members or contractors
- Support clinical laboratory procedures (phlebotomy, sample handling) for accurate data interpretation
**Required Skills**
- Proven clinical trial data management experience
- Deep knowledge of FDA regulations, ICH GCP, HIPAA, and CDISC standards
- Proficiency with EDC platforms, EMR systems, and database design
- Strong source data audit and documentation review capabilities
- Ability to detect, analyze, and resolve data discrepancies
- Familiarity with statistical software (SAS, R, SPSS, etc.)
- Understanding of clinical laboratory procedures (phlebotomy, sample handling)
- Excellent analytical, problem‑solving, and communication skills
- Ability to mentor and lead junior staff
**Required Education & Certifications**
- Bachelor’s degree in Life Sciences, Clinical Research, Informatics, or related field (advanced degree preferred)
- Certifications: Certified Clinical Research Professional (CCRP), Certified Clinical Data Manager (CCDM) or equivalent; FDA GCP training; HIPAA compliance training; CDISC Data Management professional credential.