Sandeep Bhargav B. Pharm
Senior Clinical Trial Manager @Worldwide Clinical Trials
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WORK HISTORY
Senior Clinical Trial Manager @Worldwide Clinical Trials
Miami, FL, US
Provide leadership and direction to clinical site management team members from study start through closure• Oversee regional CTMs and coordinates efforts across the CTM team• Represent Site Management issues at Sponsor, Investigator and Bid defense meetings and act as main point of contact for activities through the study• Contributes to the overall project plan, by formulating a global monitoring strategy for site initiation, enrollment, site management and closeout phases across a given region.• Provide regular input to various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed • Collaborates closely with other functions including Business Development, Regulatory, Study Start up and Project Management to achieve study goals • Develop, maintain and ensure compliance with Clinical Monitoring Plans, including budgets, study tools and Site visit reports; perform regular review of protocol deviations, Out of Scope items and oversight of action items. • Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor.• Participate in the development of and implementation of recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed.• Review of data trends and trip report issues identified for re-training of sites or CRA team. • Oversee TMF compliance of SM documents, ensuring that QC review is on target and TMF is inspection ready• Accountable for Forecasting of site visits w/CRA team to ensure staffing needs are met and any identified backlog is appropriately addressed• Sets performance expectations and provides mentoring and coaching to colleagues and project clinical staff.• Supports the study team during inspections by healthcare authorities or sponsor audits
EDUCATION
Rajasthan University of Health & Sc. Jaipur
B.Pharm, Pharma subjects
Symbiosis, Pune
PGD Total Quality managment
Birla institute of Scientific Research, Jaipur
PGD, Clinical Research & Data Managment
Symbiosis, Pune
MBA, Operation
ABOUT SANDEEP BHARGAV B. PHARM
Over 13 years’ experience in the field of Clinical Research and managing clinical trial globally mainly USA, EU and India.• History of working in pharmaceuticals (sponsor) CRO & sites globally in various therapeutic areas including but are not limited to Infectious disease (COVID-19), Oncology, Pulmonology, Ophthalmology, Nephrology, CNS, Rheumatology, Gastroenterology, Gynecology, Dermatology, Pain and healthy volunteers’ and handled phase clinical studies under FDA, EMA and DCGI regulatory guidelines.• Responsible for supporting clinical trials within the New drug development department and biotech department while encouraging positive relationships with co-workers across departments and vendors.• Execute and manage company sponsored clinical trials, ensuring compliance with study milestones• Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with the ICH-GCP, applicable regulation and Company/CRO Standard Operating Procedures• CROs Oversee activities which include but are not limited to CRO proposals review, budget grid, study award activities, regulatory issues, teleconferences with CROs to discuss study progress, follow up to meet study milestones and so on. These CROs includes but not limited to IQVIA, Covance, INC Research and inVentiv Health (currently Syneos Health) and so on for oversee activities.• Regular interaction with site personnel, IRBs/ECs, vendors, and cross functional team supporting clinical trials.• Supervise and manage assigned project budgets and timelines to ensure adherence to business plans.• Participate in bid defense meeting and site team trainings during Investigators’ Meetings• Develop clinical trial documents.• Responsible to develop study documents preparation.• Responsible to mentor study specific monitoring team. • Support in clinical project Standard Operating Procedures (SOPs) preparation and regular revision which includes but are not limited to Site qualification visit, Site Initiation visit, Site monitoring visit, Site close out visit, IP management and so on.• Responsible to review trip reports i.e, site selection, SIV, Process monitoring, routine monitoring visit and Audit reports.• On-site visit experience includes 500+ site visits i.e. Qualification Visits, Initiation Visits, Monitoring Visits, Close Out Visits. Also works on remote visits models.
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