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• Ensure the financial success of the project• Forecast and identify opportunities to accelerate activities to bring revenue forward• Identify changes in scope and manage change control process as necessary• Identify lessons learned and implement best practices

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• Provide peer-level training, mentoring of new hires and junior project management staff, and give formal technical training sessions• Participate in Investigator Meetings, support client and qualification audits as needed• Interview and hire personnel as per requirements of the organization

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• Provide inputs for the improvement of the processes

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