Utkantha Kulkarni

WORK HISTORY

ABOUT UTKANTHA KULKARNI

I am Post graduate in Clinical Research with 17 years of experience in Clinical Research industry. Experience-Worked at Sponsor, CRO and KPO end-Clientele: Hoffmann la Roche, J&J, GSK, Spectrum Oncology, Novartis, Sanofi Aventis, Sahajanand Medical Technologies, Takeda,Cipla,Abbot,Eisai,Fosun,Mylan, Abrexa, Italopharma, Astra Zenaca, Air Liquide, Esperion, Regeneron, Incyte, Asahi Kasei,Bharat Serum Vaccines,and KEM hospital. Experience: Clinical operations-Completed 1yr internship as Clinical trial monitor. CDM- Proficient in start to end Clinical Data Management activities-Skilled in study start up, conduct and close out activities with good knowledge of therapeutic areas like Immunology, Oncology, Medical device, Metabolic disorders, Infectious disease, Diabetes, Vaccines, Opthalmalogy, Cardiology, Real World Evidence studies, Academic research, Investigator initiated studies, Neutraceutricals etc. Medical writing-Worked as Medical writer authoring Narrative, Medical device CSR and Protocol. Performed quality and content review of Regulatory documents (CSR, Protocol, IB, PIP, Position paper, SCE and SCS for Phase 1-4 Clinical studies,clinical trial registry)-Worked as Medical translater for Schezoprenia AV.(English to Hindi and Marathi translation of medical content for lay person) Solution environment worked on includes OC, OCRDC, Medidata Rave, Inform, Vdigidata, Trialstat, IBM, Ecaselink, Medrio, AG capture, Octalsoft,Veeva vault. Certified in Quality monitoring and compliance from Johnson and Johnson(USA) Technical designer-Tools worked on Hyperion, JReview, Topteam, RTDC. Project management. SME-Achievements: Academics- 1)Received recognition from Mahindra and Mahindra group for SSC examination excellence year 2)Received recognition from former Home minister of Maharastra state (Shri Gajanan Kirtikar) for SSC examination excellence yr Career- 1)Part of Actemra823 team and successfully completed 1st Database lock of TCS lifescience (TCS Roche alliance) in 2009. 2)Won process improvement,multitasking awards at i3 statprobe. 3)Won highest quality score from J&J for Narrative writing alongwith Peer Medical writer. 4) Coded terms without error as Individual coder at Spectrum Oncology. Faculty: Ex visiting faculty for CDM and MW at 1)ICRI 2)Dysmec Clinical Services Conference: 1) Attended DIA India in 2024 as guest speaker. Topic- CDM and Medical coding in Medical device trial.