Clinical Data Manager

cGxPServe • Full-time • Guilderland, NY, US • 7h ago

Responsibilities

Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock.
Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to define data collection and reporting needs.
Review and finalize clinical data management documentation, such as Data Management Plans (DMP), Case Report Forms (CRFs), and data validation specifications.
Ensure adherence to applicable regulatory guidelines (e.g., FDA, ICH, GCP) and company standards for data management.
Perform data cleaning, query resolution, and reconciliation of external data sources (e.g., lab data, ePRO).
Support database setup, testing, and maintenance in partnership with external vendors or internal teams.
Perform quality control and audit activities to ensure data accuracy and compliance.
Support data reviews and provide metrics and status updates to project teams and leadership.

Requirements:

Bachelor's degree in Life Sciences, Computer Science, or a related field.
Minimum of 3 years of clinical data management experience in the pharmaceutical, biotech, or CRO industry.
Proficiency in electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or similar platforms.
Strong knowledge of CDISC standards, including SDTM and ADaM.
Excellent understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
Exceptional attention to detail and problem-solving skills.
Ability to work independently and communicate effectively with diverse stakeholders.

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