Data Manager
ird-pakistan
Karachi, Pakistan
4d ago
source : Career Okay

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)

Required Qualification

Preferably Master's in Health Sciences, Social Sciences, or a closely-related field.

Required Experience

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

Required Skills

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

Apply
Add to favorites
Remove from favorites
Apply
My Email
By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
Continue
Application form