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Curriculum Vitae for Clinical ResearchCurriculum Vitae for Clinical Research
Dr. Prayag N. Shah
[MBBS, MBA (International Business)]
Residential Address: “JALSA” - A/9, Marutinandan Villa Bunglows,
B/H Satyam Bunglows, Thaltej, A’bad – 380 059, Gujarat, INDIA
Tel: (M) +91-8128671400, (R) +91-079-29297130
Email: doctorprayagshah@gmail.com, dr.prayag@amneal.com
Date of Birth: 20th
Dec, 1981
Presently employed with:
Amneal Pharmaceuticals, LLC & Amneal Pharmaceuticals Company GmbH
(www.amneal.com) as
General Manager & Head, Global Clinical Regulatory Affairs/Global Medical
Affairs
Having +10 Years of Experience in the field of Clinical Research
Job Profile
Project Responsibilities
• Provide scientific and operational support to product specific clinical trials
and serve as sponsor medical monitor on all key clinical programs
• Collaborate with concerned verticals to undertake product gap analysis and
needs assessments (including literature reviews, internal data analyses,
competitor trial information, etc) to facilitate development of external
research strategies (e.g. areas of interest), to inform and align internal
research programs, and to optimize study design.
• Ensure all medical affairs and scientific communication functions and
activities comply with local, regional and global applicable regulations
• Ensures that clinical trial projects are properly resourced, managed and
executed within budget and in accordance with established timelines and
quality standards

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• Provide strategic and managerial oversight of all clinical trial projects from
early to late phase project specific activities including of Therapeutic area
training and protocol plus study related other aspects of training
• Responsible for organizing and implementing clinical strategies for product
specific global clinical development by keeping targeted therapeutic
indication in the base
• Prepare required regulatory documents, such as annual reports, updating of
the IB, and review of final study reports as per applicable regulatory
requirement
• Key role in reviewing and finalizing protocol and other study documents
from clinical and regulatory perspective
• Identifies KOL (Key Opinion Leaders) in related therapeutic areas and
establishes relationships and collaboration as appropriate
• Serve as sponsor medical monitor for all patient centric clinical programs
including patient PK, CEP studies – pilot plus pivotal and couple of
investigators initiated or observational survey studies
• Conduct medical monitoring as per the project management plan & ensure
prevention of wrong randomization from medical history perspective plus
resolution of all medical issues, if any
• Lead role in developing and finalizing safety management plan
• Management of vendors for various services (e.g., CRO, Translation vendor,
Central LAB, Trial site supply solution vendor) and coordination of
activities
• Travel to sites when necessary in case of contingency to resolve site specific
escalated issue/s mainly related to medical aspect or any other issues which
has impact on subject safety
• Conduct clinical plus medical feasibility of the assigned protocol by
identifying appropriate investigators, finalizing feasibility assessment
questionnaire, compile information and guide site monitor in generating
report within given timelines.
• Provide appropriate therapeutic disease & protocol specific training to entire
clinical operation and project management team to perform job duties.

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• Negotiate budgets with investigator sites, assist site in finalization and sign-
off the financial contract as per local practice.
• Due diligence of third party vendors i.e. CROs, SMOs, central LABs,
translation vendors, trial site supply solution provider, IP local depot, etc.
• Conduction of Investigator meeting
• Arrangement of DSMB (Data Safety Monitoring Board), as and when
required for particular project
• Provide extensive training to Team leader and CRAs in maintaining
effective communication with investigator site by sending visit objectives
prior to visit, ensuring that investigator is informed about the visit outcomes
including the issues and the expected actions, provide support to the site for
trouble shooting any issues during the visit and /or through interim
telephonic contacts, by ensuring accurate reporting of issues to project lead /
line manager /department head as applicable.
• Train Team leader to establish regular lines of communication with sites
staff including principal investigator to manage on-going project
expectations and issues.
• Ensure that subject’s rights and safety is protected by reviewing EC
approved informed consent forms are used by the site during the consent
process and the informed consent process is appropriately documented for
each study subject, adverse events (AEs, AEs of special interest, SAEs) are
identified, reported within specified timelines to all appropriate parties,
appropriate compensation to the subjects as recommended by the EC &
approved by local applicable regulatory agency
• Playing a lead role in overseeing entire trial specific pharmacovigilance
activities
• Oversee site activities for adverse event management, reporting to sponsor,
EC and all applicable regulatory agency/ies in timely manner
• Ensure protocol compliance in terms of conduct, documentation and
timelines by providing active oversight through review of documents,
facilities and by providing guidance and training to investigator site team

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Works closely with biostatistics to interpret and analyze clinical trial results
and outcomes, as and when required
Organizational Responsibilities
• Work closely with senior management team to achieve the strategic goals set for
Amneal pharmaceuticals in early as well as late phase clinical research activities
• Maintain current knowledge of organization standard operating procedure (SOP),
local regulations and participate in review of all SOPs and provide inputs, as and
when required.
• Participate in and contribute to personnel training seminars / programs Train other
employees (as appropriate)
• Maintains proper communications with other departments to ensure effective
communication and good relationships in connection with matters related to all
clinical projects
• Align objectives and resources across all clinical operation and project management
functions, in particular assuring that resources allocated meet business needs
• Identify future needs for resource and identify, recruit, train, develop and retain
high caliber talent
• Ensure effective utilization of all stakeholders – internal, external and other support
services and thereby minimize the need for additional head count
• Supervise and mentor the entire team on ongoing basis
• Ensure the performance of employees is proactively managed and they are coached,
trained and developed in order to maximize their contribution
• Ensure that staff communication and employee relations are managed proactively to
maximize the wellbeing of the employees
Communication and Coordination with all Stakeholders and Vendors
• Conduct project specific training for the entire team before trial commences
and supports the team by effectively addressing the issues on an ongoing
basis.
• Set up, coordinate and actively participate for internal and/or project specific
conference calls/video conferences etc.

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• Educate and train Team leader to co-ordinate and follow-up with all
stakeholders (Laboratories, Data Management, IVRS etc) involved in the
study for site specific issues.
• Educate and train Team leader & CRAs to co-ordinate with vendors or
outside agencies as per the scope of project (including translating agencies
for the front and back translations of study specific documents e.g. ICF,
diaries etc including review, finalization and receipt of appropriate
documentation viz. validation certificate etc).
Project Tracking
• Project Timeline: Establish & track project related timelines, and take
proactive decisions to ensure timely delivery
• Recruitment: Tracks the recruitment, screening, enrolment, and subject
progression throughout the study
• Monitoring visits: Track planned Vs actual monitoring and verifies
compliance to defined project monitoring plan.
• Data Quality: Track data query status and other related metrics (e.g. Open
Vs Resolved, common queries etc)
Previously employed with:
CADILA Pharmaceuticals Pvt. Ltd, A’bad. as Sr. Dy. Manager, Clinical Trial
Division, Cadila CRO. (From May 2008 - March, 2010)
Veeda Clinical Research Pvt. Ltd., A’bad as Principal Iinvestigator
(From Jan, 2007 - April 2008)

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LAMBDA Therapeutics Research Pvt. Ltd., A’bad as a clinical research physician
(From March 2006 – Dec, 2006)
Career Objective
To work in a challenging atmosphere that provides ample opportunity for learning and
growth as well and also to carve a niche in whatever I undertake and to promote
research activities to the greatest extent.
Clinical Experience
 Completed one year rotatory internship & have done major part
of clinical internship in New Civil Hospital, Ahmedabad which includes
major branches like SURGERY, MEDICINE & GYNAECOLOGY &
minor branches like E.N.T, OPHTHALMOLOGY etc.
 GPSC (Gujarat Public Service Comission) certified candidate by Ministry of Health,
Gujarat.
 Along with internship I have done job as a senior medical officer in
Nirmal Children & General Hospital, SURAT under Dr. Nirmal Choraria.
Educational Career
Examination Board/University Year Percentage/Class
1
MBA
(International
business)
Indian School of
Business Management
(ISBM)
2009 Grade I (A grade)
2 M.B.B.S.
Govt. Medical College,
SURAT
2006 First Class (63%)
3 H.S.C.
Gujarat Secondary
Education Board
1999 90%
4 S.S.C.
Gujarat Secondary
Education Board
1997 96%

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Exposure of Clinical Projects
Therapeutic
Category
Phase Submission Status
1 Cardiovascular III DCG (I) Completed
2 Anti infective III DCG (I) Completed
3 Tocolytic II DCG (I) Completed
4 Gram negative Sepsis IIb DCG (I) Completed
5
Oncology – lung
cancer
II
DCG (I),
US FDA
Enrollment completed
6
Oncology – Prostate
cancer
II
DCG (I),
US FDA
Recruiting patients
7 Bladder Cancer II
DCG (I),
US FDA
Recruiting patients
8 Osteoarthritis III DCG (I) Completed
9 Refractory epilepsy Patient
PK
USFDA ;
FTF
Completed
10 Schizophrenia Patient
PK
USFDA Completed
11 Chronic idiopathic
constipation
III USFDA Ongoing
12 Acute otitis externa III USFDA Ongoing
13 Diabetic Ischaemia IIa USFDA Ongoing
14 First in Man study I USFDA Completed
15 Sickle cell disease IIa USFDA Ongoing
16 DSM-IV
schizophrenia
Patient
PK
USFDA ;
FTF
Ongoing
17 Chemotherapy
induced neutropenia
I USFDA Ongoing
18 Rheumatoid arthritis III USFDA In development phase
19 Acne Vulgaris III USFDA Ongoing
20 Minor Ankle Sprain III USFDA Ongoing
Memorable Achievements
1. Successfully played a lead program manager role for firs to market launch
of one of the key product on the indication of OA knee. Successfully
completed FDA audit across 6 sites without any 483 & as per current
scenario, product has already been commercialized
2. Played a lead role in doing successful ANDA submission for 4 products
having first-to-file opportunity
3. Successful recruitment done in two competitive global clinical trials on
DSM-IV schizophrenia indication.

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4. Successfully faced & completed 2 USFDA audits across total 7 Indian
clinical sites for 2 different products (for refractory epilepsy & DSM-IV
schizophrenia indications) without any single 483s.
5. Successfully brought regulatory approval from Australia quickly without
any query for exclusive first in Man Phase – I study for two NCE-biologic
products.
Technical Skills
 Communication skills
 Fluency with English.
 Proficient with MS office 2007, Internet tools, Cute FTP Upload & Basic
Computer Application.
 Certified GCP Trainer
 Attended Seminars on Basic Life Support, Management of Severe Acute
asthama.
 Excellent attention to detail and accuracy.
 Good research and communication skills.
 Can take responsibility for tasks and react to changing priorities.
 Have a good interpersonal skill and are able to work in a team or own if
required
 Knowledge of Clinical Research, Drug Safety, Pharmacovigilance, Regulatory
authorities
 Capability to make concise, accurate and relevant synopsis of medical text and
data, and the ability to write unambiguous medical text
Certification(s) / Programme(s) Attended
 Attended workshop on Pharmacovigilance conducted by Dr. Moin Don &
Dr. Vivek Ahuja in co-ordination with ISCR (Indian Society for Clinical
Research)
 Attended workshop on “Pharmaceutical & Biotech Product Development and
Clinical Research- the need for a world class regulatory environment in India”

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Extra Activities
jointly organized by FICCI, DBT, ICMR, DCG (I) & U.S Department of Health
and Health Services on 26th
– 27th
Oct 06 in New Delhi.
 Indo – US workshop on Clinical Trials conducted by Seth G. S. Medical College,
Mumbai, 2006.
 Attended workshop on Basic Life Support.
 Attended presentation on management of severe acute asthma.
 Attended presentation on US FDA documents submission.
 Orientation to the Clinical Research
 Good Clinical Practices/ICH –attended workshop of 1 day.
 Protocol overview
 Case Record Forms
 Informed Consent Document
 Serious Adverse Event and Product Complaints
 Clinical Trial Record Binder
 Source Documentation
 Central Laboratory Services
 Schedule of Events
 CT Material and IVRS
 Translational Protocol
 Roles and Responsibilities as CRC
 Drug accountability
 Supplies request
 Completed 9 years course of Music (Piano Player) through Khandekar Brothers
 Performed many Professional stage shows with Mr. Bankim Pathak.
 Won several gold medals in Inter Medical College singing competition.
 Life member of JITO (Jain International Trade Organization)
 Life member of Ahmedabad Medical Association

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Desired Job Type
Permanent full time E
Desired Location
Open to Global Positioning
I hereby declare that all the entries are correct to the best of my knowledge. If chance
is given to me, I assure you that, I will prove myself as an asset to your organization.
References: On requisition. (Dr. Prayag N. Shah)