Founder & Proprietor,
Pi Clinical Research Consultancy
Dr. Gopalkrishna Pai Ph.D., DBM, CBA
30+ years of local and global drug and medical device clinical research and development experience (academic and commercial)
Experience spans over Bio-pharmaceutical and Clinical Research Service organizations
A 360o exposure to working in Medical Affairs, Clinical Research Operations & Project management, Quality Management, Training and Business Development
Skills in General Management, Administration, Corporate Laws & Finance
Start-up skills for CRO & Bio-Pharmaceutical businesses
Certified in big-data Business Analytics
Indian Society of Clinical Research (ISCR) - Life member
Bio-pharmaceutical experience at: Clinical Research Organization experience at:
GOALS:
- support management and staff in technology advancements
- project operations & finance of all bio-pharmaceutical R&D projects, especially clinical development stages
- improve quality & integrity (GCP & GLP) by conducting trainings, audits & process improvements using objective assessments
- selection of research sites & advising on setting up the right people with right attitudes at the right positions
- focus on implementation of data driven intelligent decisions in drug/device/diagnostic research projects
- help understand importance of live and real documentation to comply with global regulatory requirements
EXPERIENCE:
Worked with major multinational Bio-Pharmaceutical R&Ds & CROs as indicated in logo's seen above
Extensive exposure to medical affairs and clinical R&D aspects covering innovation, improvement, quality, integrity, project management and operational aspects along with regulatory expertise
Extensive exposure to both large and start-up settings giving a broad exposure to manage business and people aspects well
Encourage transparency, objectivity and integrity to deliver quality within timelines and regulatory bounds
Specialties
Start-ups (CRO / Pharma)
Principle-centered & high-integrity leadership
Organizational & training capabilities
Positive outlook & problem solving
Administrative & financial skill
Productivity tracking & improvement
Process & quality improvement
Extensive experience in project management (Phase 1 - Phase 4)
Cross-cultural experience (US, UK, EU, SEA region, Germany, Australia)
Office set-up & administration
Speaker at training courses, programs & conferences
Mentor & train finishing business skills
Contact
Dr. Gopalkrishna Pai, Ph.D., DBM
Proprietor,
Bangalore, INDIA
Phone: +91 98861 69223
e-mail: paigop@pi-crc.co.in