Hardik Badani
Summary
Pharma times bronze winner in 2020 in Project Management category. Portfolio Management and Line management professional with 18 years of Clinical research experience. Have worked on studies across multiple therapeutic area from Phase I-III. Have worked of key Portfolio as Portfolio Manager for EAPA and currently managing CTM manager (1) and team of CTMs and CCTMs(direct reporting). Involved in Change Management initiatives to adopt Biotech, Mid-Size Pharma and CRO business need.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Associate Director – Clinical Delivery
ICON -Previously PRA Health Science
06.2022 - Current
- Project/Portfolio Management for partial study assignment – Client Portfolio Manager for EU, APAC and LA
- Responsible as Clinical Delivery Portfolio Manager to provide oversight on key Sponsor across EAPA
- Study Finance understanding initiative for EU and APAC – Training for CTMs
- Development of new team of centralized Clinical Trial Manager (CCTM) – Plan, process and implementation
- Line management of CTM manager (1), CTMs (19) and CCTMs (09)
Manager- Clinical Delivery
ICON -Previously PRA Health Science
02.2021 - 05.2022
- Responsible as Clinical Delivery Portfolio Manager to provide oversight on key Sponsor across EAPA
- Study Finance understanding initiative for EU and APAC – Training for CTMs
- Project Management for partial study assignment
- Development of new team of centralized Clinical Trial Manager (CCTM) – Plan, process and implementation
- Line management of CTMs and CCTMs
Project lead/ CTM III
ICON -Previously PRA Health Science
08.2017 - 01.2021
- Project management, client management and finance management with dual combo role of PM/CTM
- Mentored 12CTMs : 2 China, 3 Hong Kong, 2 Japan, 2 Singapore, 2 Philippines and 2 Thailand
- SME team member for Bid defense, Cohort studies and project finance for CTMs
- Involved in EAPA (Europe Asia pacific and Africa) finance initiative for clarifying roles and responsibility for CTMs
- Received top rating for consecutive 3 years based on internal and client feedback.
- 3-Time Pharma times finalist under PM category – Bronze winner in 2020.
Clinical Trial Manager II
ICON -Previously PRA Health Science
04.2014 - 10.2015
- Manager EU and APAC countries for Top priority and key client
- Completed 2 studies start to end with quality
- Successfully supported for FDA inspection and Audits
- All deliverable achieved on time
- Client appreciation and suggested to be dedicated to portfolio
Clinical Trial Manager I
PRA Health Science ICON -Previously PRA Health Science
01.2012 - 03.2014
- Manager EU and APAC countries – Creating study plans and strategy for enrollment and backlog clearance
- Managed difficult client and study till study Closure and CSR
- Successfully supported for FDA inspection and Audits
Associate Clinical Operation Leader
PAREXEL International
07.2011 - 12.2011
- Manager APAC countries – South Korea, Taiwan and India
- Received positive feedback from client and PIs for communicating protocol related loopholes and getting them fixed
Clinical Site Manager
PPD
04.2010 - 06.2011
- Managed team in India, SK, Taiwan, NZ and HK (team of 7 CRAs across)
Sr.CRA
PPD
10.2008 - 03.2010
- Monitoring at KOLs sites
- 2 times Best CRA award
- Mentoring of Junior CRA, Sign off and Trainings
- Promoted within 6 months of joining
CRA II
PPD
02.2008 - 09.2008
- Rewarded for consistent performance and getting long team issues closed
- Assigned on project with sites and study being audited within 3 months of joining.
- Appreciated for audit preparation and site training.
- Response to Audit report was appreciated by Client and circulated as example
- Awarded for top metrics on trip report compliance
CRA
SIRO Clinpharm Pvt. Ltd
12.2006 - 01.2008
- Managed 30 sites as IHCRA and 12 sites for onsite monitoring
- Performed 80 visits in 07 months without any report being late.
- Organized and coordinated IM for 30 sites in Mumbai.
- Contract negotiation
- Ethics submission and DCGI submission
- Performed Import/ export license application
Product Registration Officer
Goldshield Pharmaceuticals
09.2006 - 11.2006
- Maintaining Record of Registered products.
- MHRA, EMEA and IMB regulatory submission and renewal of marketing license.
- Submission to incorporate update on Patient Leaflet, labels and cartons.
- Submission of PSUR.
- Faced MHRA audit in Oct 06.
Education
Certificate - Artificial Intelligence
London Business School
Business Of AI09.2021
PGD - Clinico Regulatory and Patents
Ruia College
Mumbai02.2007
M.Sc. - Biochemistry
Mumbai University
Mumbai04.2006
Skills
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Team collaboration and leadership
- Key relationship management
- Onboarding and training
Certification
- The Business of AI from London Business School – Sep 2021
- CCRA certification by ACRP – Oct 2010
- PMP certification by PMI – 2017-10 - 2023-10
Therapeutic Experience
- Oncology: Metastasis Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung cancer, and Pediatric Acute Myelogenous Leukemia, Multiple Myeloma. Role: CRA and CTM. Country: India, South Korea, Taiwan., NZ and AUS. Study phase: Phase 2 and Phase 3
- Endocrinology: Type 2 Diabetes. Role: CRAV CTM. Country: India, SOK, AUS and NZ. Study phase: Phase 3
- Infectious Disease: Chronic Urinary tract infection (cUTI) and Chronic Intra-abdominal Infection (cIAI) Chronic Kidney Disease (CKD). Role: CTM/ PL Oversight Portfolio Manager. Country: South Korea, Thailand, India, Aus, South Africa and Israel. Study phase: Phase 3
- Hepatology/ Liver disease: Chronic Hepatitis C, Chronic Hepatitis B, MASH and NASH. Role: CTM/PL/ Oversight PL. Country: NZ, AUS, HK, South Korea, Taiwan, Netherlands, Italy, US, Canada. Study phase: Phase 1, Phase 1b, Phase 2
- Neurology: Relapsing Multiple Sclerosis. Role: Lead CRA. Country: India, NZ and Aus. Study phase: Phase 3
- Hematology: Hemophilia B. Role: Lead CRA. Country: India and HK. Study phase: Phase 2
- Musculoskeletal: Rheumatoid Arthritis. Role: CRA. Country: India. Study phase: Phase 3
- Cardiovascular: Coronary Artery Disease (CAD). Role: Lead CRA. Country: India, SOK, Taiwan and HK. Study phase: Phase 3
- Skin Care: Atopic Dermatitis. Role: PL/ Oversight Portfolio Manager. Country: Thailand, SOK, Taiwan, Aus and NZ. Study phase: Phase 2/3
Timeline
Associate Director – Clinical Delivery
ICON -Previously PRA Health Science
06.2022 - Current
Manager- Clinical Delivery
ICON -Previously PRA Health Science
02.2021 - 05.2022
Project lead/ CTM III
ICON -Previously PRA Health Science
08.2017 - 01.2021
Clinical Trial Manager II
ICON -Previously PRA Health Science
04.2014 - 10.2015
Clinical Trial Manager I
PRA Health Science ICON -Previously PRA Health Science
01.2012 - 03.2014
Associate Clinical Operation Leader
PAREXEL International
07.2011 - 12.2011
Clinical Site Manager
PPD
04.2010 - 06.2011
Sr.CRA
PPD
10.2008 - 03.2010
CRA II
PPD
02.2008 - 09.2008
CRA
SIRO Clinpharm Pvt. Ltd
12.2006 - 01.2008
Product Registration Officer
Goldshield Pharmaceuticals
09.2006 - 11.2006
PGD - Clinico Regulatory and Patents
Ruia College
M.Sc. - Biochemistry
Mumbai University
Certificate - Artificial Intelligence
London Business School
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