JOB PURPOSE

The incumbent will be responsible to monitor the quality of data captured and entered on documents of a phase III randomized controlled trial. They will be responsible to ensure this is in accordance with the protocol, good documentation practice and Good Clinical Practice (GCP). The Data manager will be supervising the activity of one or more Data Entry Officers.

RESPONSIBILITIES

• Undergo training about the protocol, trial procedures, Good documentation practice and Good Clinical Practice
• Train the data entry officer reporting to him/her
• Ensure data quality is of a high standard by checking consistency of the data in the documentation
• Ensure patients documentation is filed appropriately by discussing with Site coordinator, Internal monitor and Clinicians
• Travel to trial clinic sites in Karachi as and when needed
• Review Case Report Forms and other trial documents
• Enter data into the Clinical Trial Data Base (CTDB) and supervise the data entry performed by the data entry personnel
• Perform corrections in the CTDB following safety data reconciliation upon request of the Internal monitor (quality manager) or study coordinator
• In collaboration with the CT team, answer to queries related to data received from the Internal monitor, the Central team (Sponsor) and the External monitor
• Make sure source data are appropriately recorded and filed
• Support the site clinical investigator or the delegated site clinician with data recording and entry into the endTB Worksheets
• Assist with additional tasks as agreed upon with study management
• Attend regular meetings with the endTB trial team

REQUIRED KNOWLEDGE, SKILLS & ABILITIES (KSA)