Senior Clinical Data Manager

Overview

Clinical Data Manager

Responsibilities

• Lead the design, development, and implementation of clinical data management plans (CDMPs) and
• Manage and monitor the collection, cleaning, and validation of clinical trial data to ensure accuracy
• Oversee the setup and maintenance of electronic data capture (EDC) systems and data standards
• 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.
• Bachelor's Degree Life Sciences, Health Information Management, Computer Science, or related field. Required
• Master's Degree Life Sciences, Health Information Management, Computer Science, or related field. Preferred
• 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. High