Abhishek Tyagi

About Abhishek Tyagi

A forward-thinking, goal-oriented, and value-driven professional dedicated to enhancing the quality, efficiency, and cost-effectiveness of clinical development. Possessing a proven ability to instigate transformative change through the strategic utilization of technology. Excel in fostering collaboration and synergy across multidisciplinary teams, ensuring seamless coordination and optimal outcomes.With over 20 years of extensive experience in clinical development, ranging from initial Clinical Development to post-marketing activities, including Biosimilar and Rare Disease studies. Have successfully managed global studies across America, EMEA, and APAC regions, spanning diverse therapeutic areas such as Oncology, Neurology, Psychiatry, Ophthalmology, Infection, Cardiology, Endocrinology, Vaccines, and Pain. Proficient in transition management, change management, country / hub management, clinical trial management, project management, clinical monitoring, central monitoring, risk-based monitoring, risk assessment, financial management, budgeting, study start-up activities, feasibility assessments, regulatory affairs, FSP management, patient recruitment and retention strategies, quality control, resourcing, vendor selection and management, pharmacovigilance, as well as recruitment and training processes.

Experience

1. Senior Director, Project Management - Fsp Hub Lead - India & Philippines

   Ppd

   Apr 2024 — Present · Hyderabad, IN

   Strategic Partnership Solutions Expert: Highly skilled Senior Director specializing in Strategic Partnership Solutions. Holds responsibility for Functional Service Partnerships in key areas such as Data Management, Biostatistics, Medical Writing, IRT, Clinical Supplies, Clinical Monitoring, Central Monitoring and Project Management. Primary role is to provide leadership and strategic oversight for client-specific customized solutions that support clinical development. Covering areas such as: Transition Management- Transition work from high-cost regions to low-cost HUBs.Strategic Leadership – Stays updated on the FSP market and operational landscape to develop short and long-term strategies, financial/operational outsourcing models, maximizing opportunities, adding value, and providing clients with resource continuity, increased productivity, and the ability to optimize time and costs.Partnership Leadership – Provides direction and oversight to FSP partnership teams to ensure successful delivery across three critical areas: relationship management, financial stewardship, and operational delivery. Client Leadership – Serves as Senior management liaison with FSP clients and executive governance oversight. Actively networks with industry leaders, decision-makers, and influencers within existing and potential clients, advancing FSP thinking and strategies.Commercial Leadership – Plays a crucial role in commercial leadership by engaging with marketing and business development. Works to establish and expand brand awareness, making PPD\'s FSP business stand out to present and future clients, ultimately securing and retaining business.Leadership and Governance: Manages FSP budgets, utilization, quality, and compliance and serves as a senior operational liaison for FSP clients, ensuring governance oversight as specified in contracts.

Education

• Catalyst Clinical Services Pvt. Ltd.

  Advanced Certificate in Clinical Research, Clinical REsearch

  2006 — 2006

• Indian Institute of Management, Calcutta

  EPGBM, Global Business management

  2009 — 2010

• Catalyst Clinical services Pvt Ltd

  Professional Diploma in Clinical Research, Clinical Research

  2004 — 2004

• Hemwati Nandan Bahuguna Garhwal University

  MSc., Biotech

• Hemvati Nandan Bahuguna Garhwal University ( A Central University )

  Bachelor of Pharmacy - BPharm

Skills

• Quality Assurance
• Project Management
• Training
• Line Management
• Team Building
• Ctms
• Ich-Gcp
• Gcp
• Clinical Trials
• CRO
• Clinical Monitoring
• Risk Assessment
• Pharmacovigilance
• Edc
• Clinical Research
• Clinical Development
• Regulatory Affairs
• Oncology
• Pharmaceutical Industry
• Innovation
• Mentoring
• Conflict Management
• Creativity
• Performance Management
• Therapeutic Areas
• Cell Biology
• Regulatory Submissions
• Sop
• Medical Writing
• Clinical Research Associates
• Oracle Clinical
• Drug Discovery
• Crf Design
• Clinical Study Design
• Standard Operating Procedure (Sop)
• Good Clinical Practice (Gcp)
• Clinical Trial Management System (Ctms)
• CRO Management
• Electronic Data Capture (Edc)