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.
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)
Preferably Master's in Health Sciences, Social Sciences, or a closely-related field.
Minimum of 2 years working as data manager in the health research field
Experience in using data management software
Previous clinical trial or research experience
Expert level competency in MS Office
Strong interpersonal and communication skills
Time management and problem solving skills, excellent organizational skills to independently manage work flow
Ability to work independently and show initiative
Great attention to detail
Ability to work in a multi-disciplinary team environment