Clinical Data Coordinator

Key Responsibilities

• Aid in the setup, maintenance, and closure of clinical study databases across multiple phases of development.
• Support Data Managers in ensuring data accuracy, completeness, and consistency throughout the clinical trial lifecycle.
• Perform routine data entry checks, generate and track data queries, and ensure timely resolution in collaboration with site personnel and vendors.
• Participate in the review and testing of electronic data capture (EDC) systems, case report forms (CRFs), and data validation specifications.
• Track receipt and review of external data sources (e.g., laboratory, imaging, PK/PD, ECG, ePRO) to ensure timely integration and reconciliation.
• Aid in the preparation of Data Management Plans (DMPs), edit check specifications, and data validation listings.
• Maintain documentation of data cleaning activities, ensuring compliance with SOPs, GCP, and regulatory requirements.
• Participate in data review meetings and contribute to database lock readiness activities.
• Support audit and inspection preparation by ensuring documentation accuracy and traceability.
• Perform other related duties as assigned in support of departmental and corporate goals.

Qualifications And Experience

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• Minimum of 1–2 years of experience in clinical data management or a related clinical research role within the pharmaceutical or biotechnology industry.
• Working knowledge of clinical trial processes and regulatory guidelines (GCP, ICH, FDA).
• Experience with one or more electronic data capture (EDC) systems such as Medidata Rave, Oracle InForm, or Veeva CDMS.
• Familiarity with clinical data standards (CDASH, SDTM) preferred.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work collaboratively in a hybrid team environment and manage multiple priorities.

Preferred Experience

• Exposure to complex or adaptive clinical trial designs.
• Experience supporting Phase II or III clinical trials.
• Familiarity with data from external vendors (e.g., central labs, imaging, ECG, ePRO, PK/PD).
• Experience in oncology, metabolic, or cardiovascular clinical trials preferred.
• Prior involvement in data reconciliation, SAE reconciliation, or data review listings generation.