This is an excellent opportunity to work with leading clients in the lifescience industry. Makrocare provides outstanding Clinical Data Management services for local and international studies. We handle all phases of clinical research across the full spectrum of therapeutic areas.

Our services covers activities ranging from case report form and database design to database lock and report submission.

Job Description:

• Assume the ability to meet the requirements of a CDA with a high degree of proficiency and autonomy.
• Take responsibility for specific tasks on projects, or acts as the main point of contact for all the DM deliverables on individual projects.
• Train team members on selected tasks.
• Develop CRFs, Data Management Plan, eCRF filling instructions.
• Develop project specific guidelines, e.g. SAE handling, Medical Coding, Third Party data handling and Universal ruling guide lines documents.
• Develop Edit Checks document.
• Lead UAT activities of Screen Testing & Edit Checks testing.
• Lead Data validation and Query Management.
• Identifying and reporting protocol deviations and violations.
  
• Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.
• If required liaise with 3rd party vendors to clean electronic data.
• Perform Interim and final database QC activities.
• Update all relevant tracking system on an ongoing basis.