What are the responsibilities and job description for the Clinical Data Management position at Compsciprep LLC?
Required Qualifications:
10 years of experience in Clinical Data Management within pharma, biotech, or CRO environments.
Strong working knowledge of CDISC, SDTM, and ADaM standards.
Experience with: Clinical Data Management Plans, Data Quality Plans, Data Transfer Plans, eCRF specifications, SDTM/ADaM mapping specifications, Edit checks and validation rules, Clinical data review and reconciliation.
Ability to interpret study protocols, eCRFs, CRF annotations, reporting plans, and analysis plans.
Experience managing or coordinating with CROs and third-party data vendors.
Strong understanding of clinical trial data lifecycle from data collection through analysis and submission readiness.
Ability to convert clinical requirements into clear technical specifications.
Strong communication and stakeholder management skills.
Preferred Qualifications:
Experience with regulatory submission data packages.
Experience with EDC systems, clinical data repositories, clinical data hubs, or clinical data platforms.
Familiarity with metadata-driven pipelines, automation, or AI-assisted data mapping and rule generation.
Experience supporting oncology or specialty pharma studies.
Experience working with distributed onsite/offshore delivery teams.
Knowledge of data governance, lineage, auditability, and quality controls in clinical data environments.