Job Title: Clinical Data Manager

Work Location: Remote

Summary:

The Clinical Data Manager oversees the collection, validation, processing, delivery, security, and regulatory compliance of scientific data during clinical trials. This role bridges scientific research and information technology, ensuring data accuracy for statistical analysis and supporting business development related to clinical data needs.

Responsibilities:

• Design electronic case report forms (eCRFs) and establish validation checks to ensure accurate data entry and prevent protocol deviations during study startup.
• Conduct ongoing data reviews, issue and resolve queries, and reconcile third-party data such as central laboratory and imaging data.
• Clean and lock study databases, ensuring all data is consistent, complete, and ready for statistical analysis.
• Develop and implement data management procedures and oversee data management vendors for clinical trials.
• Support and facilitate the review of medical coding for validity and completeness, maintaining high data quality standards throughout the data lifecycle.
• Ensure compliance with applicable regulations, protocols, and standard operating procedures, adhering to Good Clinical Practice (GCP), FDA regulations, and industry data standards such as CDISC/SDTM.
• Collaborate with biostatisticians, clinical operations, and contract research organizations to align data strategies and timelines.
• Stay current with industry best practices, technological advancements, and regulatory requirements related to clinical data management, implementing changes as appropriate.

Qualifications:

• Bachelor's or Master's degree in Life Sciences, Computer Science, Bioinformatics, or a related field.
• Typically 7+ years of direct data management experience in the pharmaceutical, biotechnology, or CRO industries; experience with small sponsor companies is preferred.
• Proficiency with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and programming languages such as SAS, R, or Python.
• Exceptional attention to detail, strong problem-solving abilities, and excellent cross-functional communication skills.
• Certified Clinical Data Manager (CCDM) certification from the Society for Clinical Data Management (SCDM) is desirable.

Published Category: Data Management & Programming