Senior Clinical Data Manager

Job Summary

Lead the design, development, and implementation of clinical data management plans (CDMPs) and data handling procedures. Manage and monitor the collection, cleaning, and validation of clinical trial data to ensure accuracy and completeness. Oversee the setup and maintenance of electronic data capture (EDC) systems and data standards compliance (e.g., CDISC). Collaborate closely with clinical operations, biostatistics, medical writing, and regulatory affairs teams to support study timelines and deliverables. Serve as the primary data management liaison for clinical trials, providing guidance and support to study teams and external vendors. Participate in study start up meetings, data review meetings, and audit preparation. Ensure clinical data management activities comply with GCP, FDA, EMA, and other applicable regulations. Develop and implement data quality control procedures, discrepancy management, and data reconciliation. Support internal and external audits and inspections related to clinical data. Mentor and train junior data management staff.

Responsibilities

• Lead the design, development, and implementation of clinical data management plans (CDMPs) and data handling procedures.
• Manage and monitor the collection, cleaning, and validation of clinical trial data to ensure accuracy and completeness.
• Oversee the setup and maintenance of electronic data capture (EDC) systems and data standards compliance (e.g., CDISC).
• Collaborate closely with clinical operations, biostatistics, medical writing, and regulatory affairs teams to support study timelines and deliverables.
• Serve as the primary data management liaison for clinical trials, providing guidance and support to study teams and external vendors.
• Participate in study start up meetings, data review meetings, and audit preparation.
• Ensure clinical data management activities comply with GCP, FDA, EMA, and other applicable regulations.
• Develop and implement data quality control procedures, discrepancy management, and data reconciliation.
• Support internal and external audits and inspections related to clinical data.
• Mentor and train junior data management staff.

Qualifications

• Bachelors Degree Life Sciences, Health Information Management, Computer Science, or related field.
• Masters Degree Life Sciences, Health Information Management, Computer Science, or related field.
• Required 4-6 years - of experience in clinical data management (pharmaceutical, CRO, or biotech experience preferred).
• Required 1-3 years Prior experience with EDC systems and CDISC standards (SDTM/ADaM) preferred.
• Preferred Proficiency in EDC systems as Medidata Rave, Veeva, InForm.
• High Familiarity with data standards as CDISC, MedDRA, WHODrug.
• High Experience with database lock processes, query management, and edit checks.
• High Knowledge of SAS, SQL, or other data handling languages is a plus.
• High Strong attention to detail and organizational skills.
• High Excellent communication and interpersonal abilities.
• High Ability to manage multiple projects and deadlines.
• High team oriented mindset with proactive problem solving skills.

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