Rahul Shinde
Clinical Team Manager @Ppd
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WORK HISTORY
Clinical Team Manager @Ppd
EDUCATION
ACRP Accredited Bilcare Academy
Post graduation Diploma, Clinical Research
ABOUT RAHUL SHINDE
Client focused, relationship-driven, outcome directed, and people-oriented professional with 10 years of diverse clinical research experience from early phase to late-phase trials. I have been part of various Indian and multinational pharmaceutical trials for DCGI, US FDA, and EU submission.I have led clinical studies of new drugs and medical devices in the setting of a CRO, providing operational and strategic leadership to clinical development programs, leading clinical project team, oversight of study support teams (external vendors, consultants, KOL.), engagement of stakeholders and support to the site study team.Proven track record of end to end management of complex studies and accomplishment of challenging study recruitments. I have extensive experience in cross-functional team collaboration, clinical site monitoring, study budget management, quality control, rescue studies, study systems, and databases (CTMS, EDC, eTMF, IW/VRS). I was successful in the management of FDA and DCGI (Indian regulatory) inspection of studies. Therapeutic areas: Oncology, Cardiology, Immunology, Dermatology, Neurology, Endocrinology, Gastro-enterology, Orthopaedic, and rheumatologySpecialties: Project management, Clinical team management, Clinical site management, Clinical monitoring/ Risk-based monitoring, Patient recruitment, and retention strategies.
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