Senior Clinical Study Manager

• Jul 2022 - Present

Clinical Study Manager

• Jul 2020 - Jul 2022

Clinical Study Associate II

• Jul 2019 - Jul 2020

Clinical Study Associate

• May 2018 - Jul 2019

Clinical Trial Associate

• Aug 2017 - May 2018

Clinical Data Coordinator

• Jun 2016 - Jul 2017

• Developed a database of patient treatment profile on RedCap database by curating information from the electronic medical record(EMR) system and EDC platforms such as Medidata Rave • Coordinated and managed clinical data mangement activities for the study • Validation and analyzed OncoPanel data for personalized immune-therapy • Performed clinical data review to meet study protocol requirements and SOPs • Performed data entry, tracking and reconcilliation of eCRF’s during study • Performed data quality check during study interim and close-outs • Query management on EDC platform by communicating with CROs and sponsor • Validated and performed Quality control checks on the EDC system to meet study requirements • Periodically reported adverse events on Medidata Rave and communicated safety signals to the CROs and sponsors Show less

Data analytics and literature review intern

• Mar 2016 - Jun 2016

Project: Novartis Access initiative: 1. development of database of methods and indicators of access to essential medicines programs in low an middle income countries. 2. literature review and directed study for evaluation of existing access initiatives based on the Cochrane database of systemic reviews. 3. data analysis of existing programs with generation of basic demographic charts and exploratory statistics. Project: Novartis Access initiative: 1. development of database of methods and indicators of access to essential medicines programs in low an middle income countries. 2. literature review and directed study for evaluation of existing access initiatives based on the Cochrane database of systemic reviews. 3. data analysis of existing programs with generation of basic demographic charts and exploratory statistics.

Pharmacovigilance specialist ( lifecycle safety)

• Jun 2014 - Oct 2015

Worked on Phase II and Phase III clinical trials for the 3 sponsor clinical trials in therapeutic area of Oncology, Immunology and rheumatology. 1. Receive, triage, review and process data from various sources on time, within budget and meet quality standards. 2.Perform data entry and quality check for tracking and safety database. 3. Coding relevant medical terminology(MedDRA), writing narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. 3.Pre-process material for endpoint committee or core laboratory adjudication. 4.Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. 5. Liaise with local Quintiles offices to facilitate expedited reporting. 6.Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate. 7.Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. 8. experience working on various EDC platforms and safety databases such as Argus safety database, Medidata Rave and InForm. Show less