Shyam Panhale

About Shyam Panhale

Dynamic Senior Clinical Team Lead with extensive experience at Fortrea Development India Pvt Ltd,adept at driving clinical deliverables while ensuring compliance and quality. Proven leadership inmentoring teams and managing budgets, resulting in enhanced project efficiency. Strong problem solving and regulatory skills contribute to successful study outcomes and client satisfaction.I am Confident, self-motivated and articulate professional from a unique, Biotech, life science background who manages confidential and time-sensitive issues with diligence and flexibility. Seeking to support and augment the vision of strong leadership in order to help drive the company in realizing its mission. Enjoys building and working within a high performing team to ensure high quality deliverables within the budget and timelines.SKILLS & ABILITIESStrong leadership skillsMentoring and trainingTeam motivation and integrationPlanning and organizational skillsInterpersonal skillsProblem-solving skillsClinical monitoring practicesDecision makingEscalationRisk management skillsWorkload evaluationResource adjustmentFinancial acumenBudgetingForecastingAttention to detailRegulatory understandingIndependent management ofclinical studieSr. Clinical Team Lead: • Serve as CTL for a protocol or project and assist in establishing/developing project related plans as assigned.• Review progress of projects and initiate appropriate actions to achieve target objectives.• Organize and make presentations at Investigator meetings.• Interact with internal work groups to evaluate needs, resources and timelines.• Recruitment of potential investigators, Oversight of EC submissions, notifications to regulatory authorities, translation of study related documents, organization of meetings and other tasks as instructed by supervisor as assigned.• Oversight start up team for study budgets negotiations with potential investigators and assist Covance legal department with statements of agreements as assigned• Assist with training, mentoring and development of new employees, eg Assessment visti with CRAs and Sr. CRAs• Co-ordinate designated clinical projects as a local project coordinator (with supervision if applicable) and may act as local client contact as assigned.• Perform other duties as assigned by management.• Responsible for all aspects of. clinical operation tasks as prescribed in the project plans.• Conduct and Perform QA review of the project with the QA team member once in a month.• Conduct audits.

Experience

1. Senior Clinical Team Lead

   Fortrea

   Oct 2021 — Present · IN

   Responsible for ensuring appropriate resources, coordinate and managing the clinical operation team and providing operational leadership and expertise to ensure successful of execution of clinical operations deliverables ( quality, timelines, budget and scope ) • Coordinate activities and review progress of the clinical operation aspects of projects and initiate appropriate actions to achieve target objectives.• Contribute to improvement to enhance the efficiency and quality of the work performed on the assigned projects.• Ensure all clinical operation staff adheres to professional slandered, ICH/GCP guidelines and SOPs.• Develop training materials and tools (Project Specific and Site Monitoring) as well as training specific to clinical operation staffs.• Provide clinical support to Regulatory submission and IRB/IEV approvals.• Responsible for issue escalation and Corrective and Preventive actions ( CAPA) and corrective action issue resolutions related to clinical operations deliverables.• Contribute and actively patriciate in the delivery of Bid defense presentation for new Businesses.• Develop and maintain relationship to assigned clients and serve as the client interface for all clinical operation matters.Therapeutic Experience• Endocrinology: Diabetes with Asthma and COPD - T2DM (Phase Dyslipidemia (Phase Immunology: Rheumatoid Arthritis – RA (Phase Cardiology: Acute Coronary Syndrome - ACS (Phase Genetic Disorder- Gaucher Syndrome; Phase Psychiatry – Schizophrenia; Phase Ophthalmology – Glaucoma – Phase

Education

• University of Mumbai

  M.sc, Zoology

Skills

• Clinical Research
• Pediatrics
• Diabetes
• Gcp
• Rheumatology
• Clinical Trial Management
• Inform
• Endocrinology
• Clinical Development
• Ich-Gcp
• Neurology
• Quality Assurance
• Clinical Monitoring
• Psychiatry
• Edc
• Therapeutic Areas
• Ctms
• Fda
• Data Management
• Clinical Data Management
• Cardiology