Nihal Shaikh
Clinical Research Professional
Abu Dhabi
Summary of Career
1. Performing daily database review of the allotted global projects for resolution of queries, making sure to release the safety report on time.
2. Preparing weekly monitoring reports for query management, samples due to ship from site, monitoring the pending tests in lab.
3. Responsible for maintaining and updating the patient records in electronic data systems like QLIMS, NewLIMS and CTMS.
4. Follow up with site staff/ CRA to verify the information on requisition form and reconcile the discrepancies.
5. Liaising with other departments and support services (e.g. Laboratory and specimen management) in order to expedite testing of patient’s laboratory specimens.
6. Keeping Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.
7. Regular follow up with site staff and CRAs for any outstanding data clarification.
8. Taking study handover/transition calls and attending clinical team meetings for resolutions of issues and sponsor requirements.
9. Ensuring the ordering, tracking and distribution of study materials to the sites per country specific regulations.
10. Maintaining project documentation and ensuring accurate filing and audit trial for essential documents in the database, archiving.
Experience as Trainee
Meyer Organics Pvt. Ltd.
01 May 2015
01 June 2015
• Tablet & Capsule Production and Quality Control Department.
• Exposure to different departments like raw material section, packaging & labeling, and R & D Dept.
Experience as Clinical Process Specialist
IQVIA
06 September 2016
02 April 2019
• Performing daily database review of the allotted global projects for resolution of queries, making sure to release the safety report on time.
• Preparing weekly monitoring reports for query management, samples due to ship from site, monitoring the pending tests in lab.
• Responsible for maintaining and updating the patient records in electronic data systems like QLIMS, NewLIMS and CTMS.
• Follow up with site staff/ CRA to verify the information on requisition form and reconcile the discrepancies.
• Liaising with other departments and support services (e.g. Laboratory and specimen management) in order to expedite testing of patient’s laboratory specimens.
• Keeping Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.
• Responding to requests by emails from sponsors, sites and internal teams.
• Regular follow up with site staff and CRAs for any outstanding data clarification
• Taking study handover/transition calls and attending clinical team meetings for resolutions of issues and sponsor requirements.
• Serve as a central coordinator with hospital staff, CRAs, Sponsors and project managers.
• Maintaining project documentation and ensuring accurate filing and audit trial for essential documents in the database, archiving.
• Ensuring the ordering, tracking and distribution of study materials to the sites per country specific regulations.
Accomplishments:
• Received a recognition award for quality and customer focus.
• Mentor for newly joined employees within team.
Master 01 April 2016
Master's in NutraceuticalsBachelor 01 April 2014
Bachelor's in Chemistry