Shruthi Shastry
Clinical Data Management Professional
- Role
- Senior Data Team Lead at IQVIA
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Shruthi Shastry
Have a consolidated experience of 10.5 years in core clinical data management end to end activities.Good Comprehension of Good Clinical Practice (ICH GCP) and the overall drug approval procedure. Knowledge of Clinical Research Methodology as well as Drug development procedure and 21 CFR Part 11.Therapeutic knowledge : Oncology, HaematologyDatabase Tools : Oracle Clinical (paper), Oracle RDC, J review, BOXI, iMedidata Rave, INFORM Phases of studies : 3, 3B, 1Skills : Managing a study start up, conduct and lock along with maintenance of all the relevant study documents.Have conducted training\'s on study activities in the team. Communicated site data issues with Sites, Monitors, Study Data Manager and colleagues on the Study Data Management Team and Participate in Teleconference and Minutes of Meeting. Have lead a team for six months in the conduct phase.Have attended various RAVE and co-ordinator sessions and Knowledge training as a part of the forums conducted.
Experience
Senior Data Team Lead
May 2023 — Present · IN
Education
University of Mumbai
Master’s Degree, Biotechnology
2008 — 2010
University of Mysore
Bachelor’s Degree, Biotechnology,Microbiology,Biochemistry
2005 — 2008
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