Amit More, Pmp® Email & Phone Number

Saskatoon, Saskatchewan, Canada

• Manage or support all clinical aspects of a study, including assessing operational feasibility
• Assist in managing Clinical study timelines and metrics
• Provide study-specific training and leadership to clinical team
• Prepare and present project debriefings, as required
• Plan, execute, lead or support study-specific meetings (e.g., Study Management Meetings, Investigator Meetings, Bid Defense Meetings)
• Responsible for ensuring that Clinical Team delivers timely and high-quality project deliverables

Bengaluru, Karnataka, India

• Accountable for the execution of clinical studies per contract while optimizing speed, quality and cost of delivery
• Set objectives of the project team according to agreed upon contract, strategy and approach
• Collaborate with other functional groups within the organization
• Monitor progress against contract
• Manage risk and contingencies proactively and lead problem solving and resolution efforts
• Achieve project quality by identifying quality risks and issues, and planning/implementing appropriate corrective and preventative action plans

Bengaluru, Karnataka, India

• Function as Client Services Project Manager from go-live of Cenduit’s IRT System till close-out
• Ensure deliverables are met as per agreed timelines
• Maintain the projects within scope and budget
• Assess the impact of changes to requirements on the delivered product, raise change orders as appropriate and deliver the changes as per contract amendments
• Identify risks based on ongoing assessment of data from end users and information received from clients, propose and implement mitigation plans
• Take leadership on study programs or client accounts to define standards, lessons learned, support sales and be part of SME teams

Hyderabad, Telangana, India

• Manage uninterrupted supply of Investigational Product for global clinical trials
• Support Clinical team to develop drug supply related sections in protocol and amendments
• Plan the supply strategies for the trials in order to make the drug available at right time, right locations and in right quantities
• Develop optimal packaging design to match the study design and a supply plan optimized for cost, feasibility and overage
• Set the expectations from various stakeholders at the kick-off meeting, update the project plan with agreed timelines for various milestones and monitor the progress throughout the project lifecycle
• Provide inputs on process enhancements, SOP revisions, and system updates etc. to continuously evolve to improve productivity and quality

Bengaluru, Karnataka, India

• Implement Data-driven Trial Execution, IQVIA’s Approach to Risk-Based Monitoring
• Lead a team of Centralized Monitors and Support staff to deliver centralized support as agreed with Clinical Project Managers and other stakeholders
• Identify risks and propose mitigation plans to Project Managers
• Provide regular status updates for recruitment, quality issues, study conduct etc. to Clinical Project Managers and Senior Management
• Review and approve Site Visit Reports
• Act as a mentor for new colleagues and less experienced staff for the processes of the department

Bengaluru, Karnataka, India

• Implement Data-driven Trial Execution, IQVIA’s Approach to Risk-Based Monitoring
• Interpret the trends in the data and take appropriate steps to eliminate risks in timely manner by remotely monitoring site data
• Support CRAs in preparation of Site Monitoring Visits
• Act as a Technical Expert to assist sites in questions related to protocol, study procedures etc. for the assigned studies as a part of 24X7 Contact Centre
• Act as a mentor for the new colleagues and less experienced staff for the processes of the department
• Provide inputs for the improvement of the processes

Mumbai, Maharashtra, India

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
• Provide assistance to and mentor other CRAs

Mumbai, Maharashtra, India

• Provide support to Clinical Research Associates and Project Managers
• Maintain the in-house files for assigned clinical projects
• Liaise with sites for resolution of data management queries
• Coordinate with third party vendors (couriers, translation agencies, central lab etc.)
• Support in regulatory and ethics submissions

Mumbai, Maharashtra, India

• Search for relevant candidates from the job portals, company database, personal references and head hunting as per client requirements
• Follow-up till closure of the openings

Bachelor Of Science (B.Sc.), Chemistry

Master Of Business Administration (Mba), Total Quality Management And Project Management