premkt97

premkt97

About: As a Project Manager in international, multicentric research studies, I have demonstrated the ability to lead complex clinical and public health projects across diverse global settings. I am adept at planning and executing study protocols in alignment with international guidelines, managing cross-country collaborations, and ensuring timely delivery of high-quality outputs. My role has involved end-to-end project management—from study initiation and ethics submissions to data management and close-out reporting. I possess a strong track record of: Strategic planning and implementation: Developing detailed project timelines, coordinating ethics and regulatory submissions across multiple countries, and facilitating the setup of study sites in alignment with funder and institutional expectations. Cross-cultural coordination: Leading communication and operations among international stakeholders, including investigators, site teams, funders, and data management units. I ensure seamless collaboration through regular virtual meetings, reporting structures, and problem-solving sessions. Training and quality control: Organizing training programs for site staff, including GCP and protocol-specific sessions, and overseeing adherence to SOPs to maintain data integrity and participant safety. Monitoring and issue resolution: Implementing centralized and site-specific monitoring systems, identifying protocol deviations or operational bottlenecks, and coordinating corrective actions in a timely manner. Budget and resource management: Monitoring study budgets, processing site payments, and liaising with finance teams to ensure financial compliance and transparency. Regulatory and ethical oversight: Ensuring compliance with local and international regulatory frameworks, including ICH-GCP and institutional review board (IRB) requirements. I am experienced in using tools such as REDCap, OpenClinica, Trello, MS Project, and various project dashboards for real-time tracking of progress and performance indicators. I excel in managing dynamic, multicultural teams, and have a problem-solving mindset that keeps projects on track even when challenges arise in field logistics, recruitment, or regulatory landscapes. With a strong foundation in research coordination and a proactive leadership style, I contribute not only to the successful delivery of complex studies but also to building the operational capacity of local research teams in LMICs.

Location: cmc vellore india
Job: Project Manager

Experience

  • Project Manager at Christian Medical College

    13 Jun 2016 -

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