Jaiprakash Yadav

About Jaiprakash Yadav

Clinical Research Professional with over 15 years of expertise in managing global…

Experience

1. Global Project Manager CRO Procurement Manager

   Arysta Lifescience

   Sep 2024 — Present · Mumbai, IN

   Develop study management plans, accountabilities and oversight of database and study maintenance of Clinical Trials.• Leadership of a multifunctional matrix team to ensure study oversight, study delivery and takes operational decisions at study level.• Acts as the primary operational contact for the study and leads the cross functional global team for execution of the study. • Responsible for all operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards.• Created and assisted in the development of global Clinical Trial Protocol, Study Reference Materials, data review reports, and trial statistical analysis plan in collaboration with the trial data manager.• Provide quality oversight of one or more Contract Research Organization (CRO) teams and vendors. • Veeva Vault – managing regulatory documents and tracking critical information. accountable for the company’s Trial Master File processes and systems.• Responsible for oversight and management of archival vendors and associated processes for the TMF• Conduct audits and inspections for vendor management system.• Accountability to drive assessment, selection, engagement, and management of appropriate vendors• Responsible for outsourcing services for R&D (Clinical Trials, lab, pre-clinical, new discovery).• Managed relationships with CROs and other outsourced partners, ensuring timely completion of trial deliverables and performance goals.• Identifying, evaluating and selecting suppliers based on quality, reliability, costeffectiveness and adherence to ethical and sustainability standards.• Negotiating contracts and terms with suppliers to ensure favorable pricing, payment terms and mutually beneficial agreements.• Collaborating with internal stakeholders to understand their requirements and align procurement activities with organizational goals.

Education

• Mumbai University Mumbai

  Master's Degree

  2008 — 2010

• Mumbai University Mumbai

  Advance Certificate Course in Clinical Trials

  2009 — 2010

Skills

• Regulatory Affairs
• Pharmacovigilance
• Ich-Gcp
• Data Management
• Gcp
• Regulatory Submissions
• Remote Monitoring
• Strategic Planning
• Pharmaceutical Industry
• Standard Operating Procedure (Sop)
• Clinical Project Management
• CRO Management
• Good Clinical Practice (Gcp)
• Protocol
• Clinical Research
• Clinical Trials