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Rajeev Sharan Shrivastava
334, Air Force & Naval Officer’s Enclave.
Plot No: 11, Sect: 7, Dwarka, New Delhi-110075.
(+91-11) 45242240 (Res.), +91-9810308697 (Mob.)
rajeev.shrivastava@hotmail.com
Career Objectives
 To always work with an organisation where work ethics, caring for own people,
customer focus, quality, cost-consciousness and timeliness are considered
paramount.
 Manage and excel in global assignments related to clinical research.
Current Job Profile and Work Experience
 Since April 2014: Heading Clinical Operations for India at Eli Lilly and
Company as Associate Director-Clinical Research.
 Also, Heading the regional project management responsibility for AMERIT
(South Africa, Middle East, Russia, Israel, India, Turkey) since 2011 with
reporting of AMERIT Regional Project Managers:
 Oversight of local clinical operations team comprising 6 Clinical Development
Managers and 1 Site Activation Manager.
 Maintain and succeed in current portfolio of India and work with global teams
to increase clinical operations portfolio for India.
 Work closely with team to reduce cycle time at country level and maintain
oversight to resolve operational issue/challenges at project level.
 Work with functional heads of medical, regulatory, corporate affairs to plan
strategy based on affiliate long range plan and also coordinate day to day
work related to clinical operations.
 Work closely with government agencies (CDSCO, Health Ministry) and
different industry forums (FICCI, ISCR, OPPI) on important topics related to
clinical research and working closely to resolve issues/challenges related to
clinical research.
 Oversight of relationship with key investigators at country level and do
routine field visits with CDLs.
 Maintain oversight of clinical operations budget at country level and work
closely with finance to reduce over spending.

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 Work proactively on challenges related to team and overcome those for
clinical operations and mitigate risk.
 Doing Performance management for the team.
 Since January 2011:
Working as Associate Director-Clinical Research for AMERIT (Africa, Middle
East, Russia, Ukraine, India, Israel, Turkey) with following job responsibilities:
 Both Line management and Project management responsibility for the
Regional Project Managers for AMERIT. Current team size of 6 regional
project managers & one CCPM Specialist for the region.
 Regular coordination with regional director to work on strategic intent for the
region and bring consistency in work approach and cycle time reduction for
each country.
 Regular discussion with CRO/TPOs and other partners working for Lilly in
functional outsource model.
 Follow up with CRO functional head for AMERIT to understand PTL
allocation, study management activities, coordination between the PTL and
CSM.
 Attend regional and global meetings with respective COMs from each country
of the region and discuss regional matrix focusing on study delivery and cycle
times.
 Work with CRO functional head on high level of coordination of project
management work so that cycle time could be reduced at country and
regional level.
 Provides project management oversight for the region and help regional
CSMs in tracking of enrolment, resolves enrolment issues, implements
enrolment acceleration and patient retention programs.
 Oversee study specific kick off meetings planned by regional CSMs.
 Regular meeting with individual CSM and get study updates and help in
resolving operational and project management issues where ever needed.
 Doing Performance management for regional project manager team and help
team members to overcome issues and be successful in the role.

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 Since July 2007 to September 2010
Worked as Senior Manager-Clinical Research with Eli-Lilly and Company at
India affiliate.
My work responsibilities included Project management as well as Line
management for my team which involved 5 members with global clinical trials in
Oncology, Endocrinology, Psychiatry therapeutic areas.
My job responsibilities include:
 Involvement in final patient allocation process with corporate based on
company’s objective and compound planning.
 Providing realistic estimation on study bidding process based on experience in
disease state/therapeutic area, study timelines, study feasibility.
 Finalisation of study budget and providing it global study team.
 Finalisation of country level timelines, achieving the FPV at country level.
 Ensuring that clinical studies are conducted according to the global timelines
and objectives set forth in the overall Project Management Plan.
 Doing the performance management, career development planning for all the
team members.
 Interacting with cross functional departments for operational and study specific
requirements.
 Looking after different study team project specific requirement and the need of
study specific trainings.
 Keeping regular meetings with study team for meeting the quality standards
(ICH-GCP, Company SOPs), timelines for the study.
 Helping the team to resolve study related problems/issues. Following up with
study teams at regular intervals for timely resolution of issues.
 Taking up responsibility for new initiative at affiliate level for making the
operational end more systematic.
 Owning responsibility for the implementation of daily operations associated
with managing clinical studies.
 Applying effective project management skills including translating development
objectives into relevant, tangible, and measurable goals; monitoring progress
toward goals; and participating in problem identification and resolution.
 Better managing the resources in a clinical study.

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 Coordinating with the DRA colleagues for MoH submission and approval
status.
 Aligning and motivating team members to meet customer needs and
organizations’ strategic direction.
 Being responsible for inspiring, motivating and promoting team health.
 Interacting with “service providers” to ensure that the project deadlines are
met.
 Developing and consolidating clinical research capabilities in order to deliver
high quality data.
 Working closely with colleagues in Clinical Development and Operations
Support.
 Developing project-tracking tools to ensure that the project is moving ahead
according to specifications.
 Promoting implementation of uniform processes across the projects.
 Being responsible for personal and colleague development including
recruitment, retention and career development.
 Involved with start up meeting finalization and helping team in other study
milestones.
 Since September 2005 to July 2007
Worked with Novartis Pharmaceuticals in their clinical research operation which
is a part of ICRO (International Clinical Research Operation running in 72
countries out of global presence of 140 countries) as Senior ICRO-CRA.
Work Profile: I was responsible for phase II to phase IV of clinical trials
according to ICH-GCP guide lines. I had been involved with two global trials of
cardiology (Indications: Hypertension), metabolic diseases (Indication: Diabetes)
and one global trial on Dermatology & Immunology (Renal Transplant) across 10
sites. I had also been involved with psychiatry trials during the pre-start up and
start up activities.
Here my job responsibilities were mainly related to the following activities:
 Site Selection:
a) Identifying the potential investigators for the study.
b) Contacts and visits potential investigators.
c) Ensures adequacy of clinical research staff/facilities with regard to
SOPs, GCP, and appropriate regulatory requirements.

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d) Identifying issues and arranges for resolutions with the help of team
members.
 Compiling the regulatory documents and handing over to the regulatory
colleagues for MoH submission.
 Doing the EC submission as per the submission timelines of the different sites.
 Study Start up Meetings & Study initiation:
a) Finalisation of agenda, presentations of study start up/Investigator
meetings.
b) Conducting the site initiation visit after receiving the EC approval, approved
signed copy of letter of agreement was received.
c) Giving a presentation on the protocol and ICH-GCP guidelines.
d) Giving a presentation on informed consent process, SAE reporting.
e) Familiarising the site with study related documents which needs to be filled
mainly ICF, CRF, Lab requisition
f) Discussion on study related documents and getting it signed from Principal
Investigator (Confirmation of source documents, Signature and function
log)
g) Resolving all the queries related to study related procedures.
 Doing the site monitoring visit and doing the office based monitoring at regular
intervals.
 Since all the studies were e-CRF based, regular review of e-CRF for each site
was done from office (remote monitoring). Main focus was to look at no. of
queries at each site and coordinating with the site to get the queries resolved.
 Using different software tools to track the milestones, documents and timelines
for the study (IMPACT, WinFx, EDC module, CITRIX, CREDI, iMan)
 Compiling and reconciliation of the study related budget at regular intervals.
 Doing Site Monitoring.
 Conducting the site closeouts.
 Since July 2004 to September 2005.
Worked with Reliance Clinical Research Services as a Clinical Research
Associate. I had been mainly involved with three Oncology projects (Indications:
Lung Cancer, Multiple Myeloma, Cerebral Tumours) and one project on Sepsis
across seven sites. Here my job responsibilities were mainly involving:

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Pre start up Phase:
a) Collecting all documents for regulatory submission.
b) Preparing the internal documents and getting the documents approved as
per the company SOPs (mainly ICF, Letter of agreement)
c) Organising and doing the EC submission for study approval at the site.
d) Interacting with vendors for conducting the start up meeting.
Site Initiation:
a) Conducting the site initiation visit after receiving the EC approval, approved
signed copy of letter of agreement was received.
b) Preparing and compiling the site related documents.
c) Giving a presentation on the protocol and ICH-GCP guidelines.
d) Giving a presentation on informed consent process, SAE reporting.
e) Familiarising the site with study related documents which needs to be filled
mainly ICF, CRF, Lab requisition
f) Discussion on study related documents and getting it signed from Principal
Investigator (Confirmation of source documents, Signature and function log)
g) Resolving all the queries related to study related procedures.
h) Documenting the site initiation visit.
Site Monitoring:
a) Conducting the monitoring visit at the site as per the monitoring plan and
company SOPs. During monitoring, attention was mainly paid to the following
points:
b) Assessing the overall Investigational site performance.
c) Ensuring the compliance of investigator and other site staff as per protocol
and GCP and initiates actions to resolve issues.
d) Ensuring that the regulatory documents are available and current, for
example, the Investigator File or Regulatory Binder and the approved
informed consent form.
e) Doing the source data verification as per the monitoring plan and also based
on personal assessment of overall performance of the site.
f) Reviewing CRF’s for completeness and accuracy and ensures that
corrections are made appropriately.

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g) Reviewing Adverse Events reports, both serious and non-serious, for
completeness and accuracy, and makes sure agreed procedures have been
followed and reports them according to SOPs.
h) Reviewing Data Clarification Form (DCF) and forwards to the site for
necessary resolution.
i) Identifying the site problems, for example enrolment issues, site personnel
leaving the site while the study is ongoing and initiates action to resolve
these.
j) Ensuring that the investigation product is in required temperature condition
and accountability was performed. Ensuring the accountability of other study
related material.
k) Resolving CRF based queries at regular interval and preparing for the final
database lock.
l) Identifies and records quality problems. Suggests, initiates, recommends
and/or provides solutions as appropriate.
m) Retrieving the CRFs on a regular basis.
In-house Monitoring:
a) Preparing the monitoring reports with in the given timeframe of company’s
SOP.
b) Doing office based monitoring at regular interval and documenting it for
internal records.
c) Reports regular study status update to CTL/Project Manager.
d) Recording Serious Adverse Events.
Site Closeouts:
a) Retrieving the CRFs.
b) Ensuring regulatory documents are available and current.
c) Ensuring CTM accountability and CTM return and disposal.
d) Ensures that investigator has supplied final report to the Ethics Committee.
e) Ensures final payments have been processed.
 Since Jan 2004 to June 2004

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Worked with N.D.M.C Charak Palika Hospital, New Delhi. as a resident doctor in
the Emergency Deptt.
a) Reviewing all kind of emergencies.
b) Starting the treatment and shifting the patient in respective departments.
c) Attending OPD in day duty.
 Since August 2003 to Jan 2004.
Worked with Safdarjung Hospital (Govt. of India) in the Deptt. Of Neurosurgery
as a resident doctor.
a) Reviewing and managing the inpatient in neurosurgery department.
b) Attending and seeing the patient in Neurosurgery OPD.
c) Attending the emergency duties and reviewing the emergency cases mainly
head injuries (EDH, SDH)
Academic Qualification
 M.B.B.S
University of Mumbai, Passed out in August, 2003.
 XIIth
Passed out in 1996 from G. B Sr. Sec. School, New Delhi
 Xth
Passed out in 1994 from G.B Sr. Sec. School, New Delhi
Additional Certifications
 CIPM: Certificate in International Project Management from IAPM, UK.
 VSCR: Certified Clinical Research professional from Vienna School of Clinical
Research.

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 Professional Registration: Registered as physician with Medical Council of
India. Also registered with Maharashtra and Delhi state medical council.
 Member of Indian Society of Clinical Research.
 ICH-GCP certification from Institute of Clinical Research, UK which is also
certified by Royal College of Physician, UK. 25 continuing professional
development points were awarded.
Other Association with in Eli Lilly and Projects Undertaken:
 Worked in setting the Regional CSM team for AMERIT in 2011 and since
then leading the team for the region.
 Worked as core team member in setting up Site Activation Team for
AMERIT.
 Involved as team member in development of regional Clinical Management
Plan and Quality work plan during Project Starlight.
 Involved as team member in Global Site Monitoring Process (GSMP) from
India.
 Involved as team member in Six sigma project on affiliate business plan
and regulatory strategy.
 Six Sigma Kaizen Project 2008: Involved as team member in a Kaizen
Project on ICD process improvement.
 Six Sigma Project on Letter of Agreement: Involved as team member in the
project.
Conference Attended
 Invited as guest speaker in International Pharmacogenomic conference, San
Francisco in April 2011 by IIR, USA
 Invited as guest speaker by IBC Asia in “Partnership in Clinical Trial Asia Pacific-
2010” in Singapore with presentation on “Different Outsourcing Models-Is there
any right model”
 Invited as guest speaker in Clinical Trials & Partnering India 2010 organised by
IBC, Asia. Gave presentation on “Communication & Management of Expectation”
with focus on better CRO work management.
 Given presentation in SEAROC cancer centre, Jaipur as part of GCP workshop.

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Training Received
 Received CIPM training from IAPM, UK.
 Received advance GCP training from Vienna School of Clinical Research, Vienna
 Passed the GCP Compliance Exam at Workshop on Clinical Research & ICH-
GCP guidelines, Beijing, China, part of Novartis global training programme.
 Attended workshop on Effective Communication & Leadership skills from a top
notch management institute MDI, Gurgaon.
 Attended a Team Leader training meeting in Shanghai, China with workshop on
managerial level skills, project management skills from American academy,
Singapore.
 Attended Oncology Clinical Trial Workshop in Indianapolis, US.
 Received ICH-GCP training from Reliance Clinical Research Services.
 Attended workshop on “Time Management skills” from Mercuri International.
 Received training from Novartis ilearn system for “Techniques for Better Time
Management”
 Attended 3 day workshop on clinical research from Indian Society of Clinical
Research in June, 2007.
 Received training on different software used in clinical trials like Winfx, Citrix,
EDC, Phosco and other related software. Doing all e-CRF based studies.

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Co-Curricular Activities And Interests
 Playing Badminton.
 Reading Books.
 Watching documentaries and movies.
Personal & Family Details
Father’s Name : A.K Shrivastava.
Mother’s Name: Sunaina Shrivastava
Date of Birth 27 / 07/ 1978
Sex Male
Nationality Indian
Family Details Wife and 2 lovely kids.
Date: (Rajeev Sharan Shrivastava)