The Clinical Data Supervisor will:

Analyze the enrollment status and alert the clinical program manager if unusual activities or absences of activities are detected

Verify accuracy of case report forms agait study protocol

Monitor clinical data entry time and completeness based on scheduled clinical visits during a trial

Review laboratory data periodically and identify any laboratory values that are significantly outside the normal range.

Perform initial assessment to determine whether the abnormal values may result from a laboratory error or may be clinically significant and alert appropriate clinical project team membe accordingly.

Review inclusion and exclusion criteria, medical history, demographics and or other baseline characteristics of study subjects to alert team to any eligibility violation

Review advee event data and concomitant medication use to detect unusual or absent activities. Identify outlie in safety data pattern.

Review and revise advee event and medication coding for coistency and accuracy

Perform periodic pharmacovigilance analysis to detect safety signals

Generate graphs and reports using spreadsheet and database tools

QUALIFICATIO:

Bachelor of Medicine, or higher

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

Proficient in English reading and verbal communication

Proficient in Microsoft Excel and data table manipulatio

Familiar with statistical methods for data analysis

Familiar with medical terms and laboratory testing principles

Familiar with database structure and electronic data capture is a plus