Job Description

The Clinical Data Manager (CDM) is responsible for clinical data management operations and activities such as data review (Query management, data listings review etc.) including external lab vendor and SAE reconciliations. CDM is also responsible for EDC testing, data cleaning, and ensuring compliance with regulatory data standards (CDISC, SDTM). The role requires proficiency in EDC Systems (like Medidata Rave, Oracle InForm, Veeva vault) and strong knowledge of clinical trial processes.

The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; understand the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

ESSENTIAL FUNCTIONS

• Performs day-to-day DM tasks under the direction of Study Lead or Line Manager
• Perform ongoing data review, identifying discrepancies and ensuring data quality
• Conduct external data reconciliation (e.g., lab, imaging, SAE data)
• Generate and resolve queries in alignment with data management plans
• Create and distribute metric reports for study tracking and performance insights
• May serve as backup for study leads or lead simple studies independently
• Collaborate closely with EDC vendors, sites, and cross-functional study teams
• Contribute to study management by acting as backup for study leads or leading simple studies
• Demonstrated ability to work independently and lead study-level data operations
• Experienced CDMs may as backups for Study lead or may lead the simple studies

EXPERIENCE REQUIRED

• At least 8 years of experience
• Proficiency in EDC Systems (like Medidata Rave, Oracle InForm, Veeva vault)
• Strong knowledge of clinical trial processes and regulatory data standards (CDISC, SDTM)
• Execute medical coding using standard dictionaries (e.g., MedDRA, WHO Drug)
• Familiarity with CDISC standards, GCP, and regulatory data compliance
• Execute medical coding responsibilities using dictionaries such as MedDRA and WHO Drug
• Proven mentorship experience and ability to train junior staff
• Experience in specialty data functions such as coding, pharmacovigilance, or lab oversight
• Medical coding (there is no separate role for this, CDMs are done the medical coding)