Bhavanesh Patel Email & Phone Number

Massachusetts, United States

Paris, France, Fr

Paris, France, Fr

Waltham, Ma, Us

• Ensure continuous product supply in support of clinical trials.• Work with internal and external customers and suppliers to accomplish project objectives, and develop early stage DS (Drug Substance), DP (Drug Product) and IMP (Investigational Medicinal Product) packaging and distribution plans.• Monitor inventory levels and provide feedback to the appropriate resources regarding expiry and resupply.• Support Clinical Supply Chain initiatives and continuous improvement activities.• Drive and lead end-to-end clinical supply chain activities to ensure successful trial supply management.• Partner with Clinical Operations to identify demand assumptions and create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and programs• Review clinical trial protocols and understand impact to supply• Participate in cross-functional project team meetings• Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered• Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues• Support development of IRT and participate in User Acceptance Testing• Develop and maintain applicable metrics• Review and update SOPs and identify the need to assist in establishing new procedures.

Waltham, Massachusetts, Us

Perform protocol review with sponsor and internal stakeholders for budgeting, demand forecasting, production & supply planning and kit designing.Lead and Participate in project kick-off and initiation meetings for study design review, recruitment rates, kit demandDevelop supply strategy as per demand and supply planning as per study requirements.Ensure minimal product and supply overage.Liaise with purchase team for material sourcing and vendor quality issuesCollaborate with production engineering and packaging team for scheduling and demand planningCommunicate & Consult with sponsors for finalization of kit design, supply strategies utilizing global depot network.Utilize organizational business tools for Trial Supply Forecasting after Data AnalyticsTrack project budget and financesEnsure resource optimization across the project scope including Cost, Quality and TimeAccountable for periodic client communication to distribute project updateEnsure accurate inventory management and material sourcing for allocated client accountsCoordinate with IRT Vendor for IVRS & IWRS designs and amendments including UAT & Go-LiveFinalize and approve MRS (Master Randomization Scheme)Plan & organize governance and business review meetings with allocated clientsManage client meetings, business reviews, proposal development, and close supervision to all business activities to ensure friendly and efficient transactions throughout the project life cycle.Coordinate with Logistics team and Customs Brokers for hassle free clearances

Chennai, Tamil Nadu, In

Project Management –Lead & supervise project management team for pre-clinical, phase II & III clinical trials and bioequivalence studiesAct as Single Point of Contact between internal stakeholders and sponsors for assigned projectsPrepare, Implement and Monitor of clinical study planning and executionManage multiple projects in complex matrix for on-time submission for final reportTrack and Monitor project finance as per approved study budgetPeriodic in-person project review meetings with sponsorsConduct project review meetings with internal teamEnsure adherence to project plan and scopeCoordinate with cross functional team for timely project executionResources Optimization for monitoring and subject recruitmentEnsure supply availability to meet with patient recruitment and treatment schedulesComplaints management including protocol deviations, GCP deviations and organizational processesManage biological samples shipments with 3rd party logistics vendorsBusiness Development –Represent Company at various conferences and industry meetings (CPhI, AAPS and DCAT)Maintain high visibility within customer organizationsIdentify, evaluate and prioritize potential clients for targeted business development activitiesEstablish and maintain client relationships; work closely with management and team members to define business development and marketing strategyOversee all aspects of business development including customer relationship management and project management.

Chennai, Tamil Nadu, In

Waltham, Massachusetts, Us

Develop and implement IMP supply strategy with Clinical and Medical project managers and contract providerMonitor set-up with contractors, monitors progress, issue management, complaint handling and resolution with CAPACoordinate periodic vendor meetings and business reviewCollaborate with internal and external customers to develop and implement IMP return drug management activitiesAssists in development of IVRS supply and return strategy and participates in UAT (User Acceptance Testing)Manage Clinical Supplies IMP project files ensuring inclusion of essential documentation and archiving of interim working notes.Coordinate and prepare pre-audit/inspection reviewClinical supplies inventory management for allocated projectsEnsure final product reconciliation is accurately completedLead or participate in global supply or return process-improvement initiatives, developing rational and creating implementation plans for change.Represents Clinical Supplies & Global Logistics for global R&D or other company process improvement initiativesLead and represent Supply Chain Division during client audit from the clinical supplies and distributionClient communication related to all distribution activitiesManage process flow for returns and destruction of IP.

London, England, Gb

Import shipment requisitions for global and local distribution using business tool WorldStarBook and pre-advise shipment.Organize and order drivers (Delivery/Pick-up of the Import shipments, Pick-up/delivery of the shipments at the freight companiesMonitor shipments during the transport and reacts flexibly to any deviation from the plan.Identify and escalate issues related to clinical supplies including import & export shipmentsEnsure adherence to global and local regulatory requirements for hassle free import-export shipmentsSupervise warehouse and inventory levels for packaging supplies, cooling media, shipper boxesCommunicate and collaborate with contractors, third party vendors, transporters (airlines, handling agents, customs, government agencies and suppliers