Amitesh Thakur Email & Phone Number

Mumbai, Maharashtra, India

• Prioritizes and effectively manages the oversight of the start-up strategy and execution by leading a team of Global Study Startup Associates for assigned studies. This includes supporting site identification, site.
• Ensures quality standards and applicable regulatory requirements are met in accordance with the protocol, applicable guidelines, and local regulations for IP release and site activations.
• Communicates effectively with the sponsor, project manager, functional team leads, and other project team members regarding study start-up strategy and risk mitigation planning. Selects appropriate communication.
• Identifies potential risks associated with start-up activities and deliverables, including proactive contingency and mitigation planning.
• Responsible for the management of resources and resource projections to ensure project teams align with client needs, expectations, and contractual obligations.
• Provides functional management support to direct reports, including professional development, performance appraisals, and employee counseling/mentoring.

Mumbai, Maharashtra, India

• Leading team of Centralized monitors and Clinical Study Associates for execution of Clinical Trial projects for client.
• Provide technical support in conducting in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data).
• Project oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, standard operating procedures, respective regulation and guidelines.
• Serves as operational point of contact for assigned deliverables for customer or projects/specified.
• Establishing and maintaining project monitoring, control and reporting tools, that supports ongoing assessment of project life cycle and team performance.
• Assuring effective reporting for project schedule, scope, resourcing, quality and risk exposure.

Mumbai Area, India

. Establishing and maintaining project monitoring, control and reporting tools, that supports ongoing assessment of project life-cycle and team performance.. Assuring effective reporting for project schedule, scope, resourcing, quality and risk exposure.. Responsible for effective transition of new processes.. Supporting client for ongoing review of.

Pune Area, India

• Reviewed site-level essential documents to ensure compliance with Sponsor and Investigator obligations, including adherence to Sponsor SOPs/WIs, relevant country regulations, and ICH/GCP guidelines.
• Update systems in a timely and accurate way, maintaining site-related data in applicable clinical systems according to procedures and guidelines.
• Review study data from various sources remotely, collect study documentation and resolve issues/requests outstanding information.
• Manages the set up and maintenance of electronic Trial Master Files (eTMF) for clinical studies in accordance with TMF processes.
• Responsible for gathering data requested by study team to support status reports to clients.

Pune Area, India

• Coordinate and oversee all aspects of clinical research studies, including the recruitment, screening, and enrollment of participants.
• Collect and manage data and documentation with precision and timeliness.
• Maintain clear and effective communication with study sponsors, investigators, and team members.
• Ensure strict adherence to study protocols, regulatory requirements, and ethical standards.
• Train and supervise research staff, ensuring compliance with study protocols.
• Handle day-to-day tasks related to monitoring and managing clinical trials, including managing informed consent and protocol adherence, and collaborate with team members and external stakeholders to ensure successful.

M.Pharma, Pharmacology

Bachelor Of Pharmacy (B.Pharm.), Pharmacy