Anil Golani
Tel : 91-983*******
Email :**********@*******.**.**
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A competent professional with significant functional experience in the
sphere of Pharmaceutical/Clinical Research and striving to be a key player
in achieving organizational objectives by utilizing domain knowledge.
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PROFESSIONAL SYNOPSIS
< More than 8 years of experience inclusive of Basic & Clinical Research
and Marketing.
< 7 years experience in Clinical Research that includes Scientific
Writing, Site Feasibility, Patient Recruitment & Retention.
< Developed Epidemiology Reports, White Papers, Articles, Abstracts and
other clinical write ups.
< Knowledge of writing Clinical Study Reports (CSR), Manuscripts, ICF
and Protocol Development.
< International Publications- Co-Published in British Journal of
Clinical Pharmacology, 2008;
Molecular Diagnosis and Therapy, 2009.
< Co-Authored poster presentations in National & International
Conferences.
< Laboratory Research experience in Infectious disease (Tuberculosis).
< Quality driven, Self motivated, Enthusiastic, team player with strong
determination and management skills.
< Organized, detail oriented & ability to rapidly learn and innovate in
new areas.
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CORE COMPETENCIES
Scientific Writing & Editing
Literature search compilation
Team Management Strategy Planning
Quality Management KOL Mapping & Management
Project Management Market
Identification/Penetration
Clinical Site Feasibility Medical &Scientific
Communication
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CAREER FEATURES
Medical Specialist
January 2014 - Present
Medulla Communications Pvt. Ltd
Mumbai, India
Role:
< Conducting literature search for developing medical communication.
< Developing medical communications for leading Pharmaceutical & FMCG
Healthcare companies.
< Preparing newsletters, visual aids, communication for sales force,
slide decks, healthcare pages on social media.
< Understanding client's medico-marketing requirements.
< Coordinating with internal client servicing team recommending medical
content solutions fitting client's requirements.
Sr.Clinical Research Scientist
August 2010 - December 2013
MakroCare Clinical Research Ltd.
Hyderabad, India
Role:
Scientific Writing
< Review of literatures from various sources including PubMed,
publications, etc.
< Developed scientific materials: white papers, articles, abstracts for
scientific conferences, research articles summary, slide decks,
disease epidemiology reports.
< Developed disease specific clinical write ups for bid defense purpose.
< Prepared country reports covering healthcare system, regulatory,
ethics, and market authorization.
< Developed web content material for company website.
< Prepared patient narratives as and when specified.
< Knowledge of writing Clinical Study Reports (CSR), Manuscripts, ICF
and Protocol.
< Constructed clinical trials trend analysis report and liaised with US
team.
< Interacted with clinical development team and improvised content.
< Provided timely & accurate scientific data to internal & external
customers.
< Coordinated with clients in understanding their requirements.
< Ensured deliverables met project specifications, quality and
timelines.
< Trained junior writers for their writing activities.
< Supported colleagues in non-clinical activities and set up initiatives
like metrics tracking, knowledge sharing, training, etc.
< Independently wrote most of writing assignments with minimal guidance
from senior staff.
< Responsible for preparation of assigned documents to high standard as
per company's SOP and client requirements.
Feasibility/Site Start up
< Developed site feasibility questionnaire as per protocol requirement
< Studied pre-feasibility information on incoming protocols/projects.
< Clinical site travel to assess feasibility and site level
requirements.
< Interacted with PI's for any protocol queries/suggestions.
< Site liasoning & development, assisted business analytics division for
budget preparation.
< Assisted in designing patient recruitment strategies on incoming
feasibility as per country requirement.
< Attended clinical project meetings, clinical training sessions as per
project communication, monitoring and / or training plans.
< Training to site personnel when required.
< Provided assistance to study team for preparation of study start-up
materials.
< Supported in preparation and conduct of investigator meetings.
< Prepared site visit report as per SOP/sponsor requirements.
< Assisted, coaching and mentoring of junior team members.
< Submission of CTA, follow-ups and query resolution.
< Supported in development of ongoing review of organization SOP's.
< Active participation in interdepartmental meetings and trainings.
Business Development
< Assisted business development and marketing teams in regards to
clinical site management activities.
< Supported in pre-sales activity by contributing inputs to incoming
RFIs, RFPs.
< Supported in business meetings by contributing domain expertise.
Miscellaneous
< Maintained GCP Helpdesk website & troubleshooted received questions on
GCP from time to time.
< Developed current and comprehensive medical information database on
different therapeutic areas.
< Analyzed data for Phase II and III trials in South East Asia.
< Key team member in developing regulatory intelligence tool for company
use.
< Provided inputs in development of training modules, metrics tracking,
and its periodic up gradation.
< Maintained clinical trial documents in appropriate study files.
< Attended seminars and conferences periodically.
< Assisted in internal and ISO audit preparations.
Project
Title: KOL Mapping and Identification
Designation: Team Lead
Role:
< Identified KOL's in Neurology, Pulmonology, ENT, Dermatology, and
Pediatrics.
< Mapping of OL's & KOL's on basis of competitive Intelligence metrics.
< Guided other team members on data collection strategies.
< Supervised team performance from time to time.
< Coordinated with internal team understanding client requirements.
< Projected study deliverables to PMO team as needed.
< Resolved issues arisen if any.
< Ensured smooth project flow.
White Papers developed:
< Cancer in Emerging Markets of the world
< Patient Recruitment & Retention Oncology trials-
Challenges & Best Practices
< Patient Recruitment & Retention CNS trials-Challenges &
Best Practices
< Patient Recruitment & Retention Pediatric studies-
Challenges & Best Practices
< Oncology Trials in Emerging regions-A trend analysis
< CNS Trials in Emerging regions-A trend analysis
< Feasibility & Site Optimization in Oncology clinical
trial
< Post Marketing Clinical Follow up
< Regulatory Environment & Clinical Trials - South East
Asia
< Epidemiology report on Non-Small Cell Lung Cancer in Asia
< Epidemiology report on Breast Cancer - Global
Perspective.
Accomplishments:
Scientific deliverables created were well liked and
appreciated by target audience.
Research Executive - Medical
August 2009- July 2010
ADI Back Office Professionals Pvt. Ltd.
Mohali, India
Role:
< Gathering requisite information by literature search for drugs,
medical devices using web,
and published materials.
< Maintained database of collected information.
< Data Analysis using excel and making a comparative.
< Preparation of detailed report as per client requirement.
< Training of other team members
< Other duties as and when assigned by manager.
Laboratory Technician
April 2004 -August 2007
National Institute for Research
in Reproductive Health, Indian Council of Medical Research (ICMR)
Mumbai, India
Project
Title: To Study transfer potential of Isoniazid from circulation to
breast milk in lactating women on chronic
therapy for tuberculosis and studying of genetic polymorphisms
associated with it.
Role:
Clinical Research
< Assisted in conducting site selection, site development and
close-out endeavors.
< Assisted in recruiting potential subjects by validating
inclusion/exclusion criteria.
< Assisted in developing ICF and Protocol as per study
requirement.
< Explained subjects about the study procedure.
< Reviewed ICF and facilitate translation into local languages.
< Facilitated meeting arrangement with Ethics committee.
< Maintained a record of patients enrolled for the study and
their collected samples.
< Maintained inventory of study supplies and its documentation.
< Ensure management of clinical supplies in compliance with
protocol and overall clinical objectives.
< Stored samples from study site to the laboratory for further
analytical research.
Laboratory Research
< Assisted in analyzing study procedure by reviewing literatures.
< Standardized HPLC for determination of anti-tuberculosis drug -
Isoniazid.
< HPLC analysis of patient samples and data recording for
analysis.
< Assisted in data analysis using appropriate statistical tests.
< Helped in carrying out detection of NAT2 polymorphism using PCR
and RFLP techniques.
< Conducted gel electrophoresis of PCR samples, observation and
interpretation of results.
< Collected tissue samples for RNA/DNA extraction from
commercially available kits.
Miscellaneous
< Key member in setting of new laboratory.
< Maintained record of laboratory supplies.
< Coordinating with internal staff for management and receipt of
study materials.
Accomplishments:
Co-Published in a International Journal- (1) "British Journal of
Clinical Pharmacology" in 2008
(2)
"Molecular Diagnosis and Therapy" in 2009
Data Executive
February 2002-March 2004
Battaerd Mansley Pvt. Ltd. - subsidiary of IMS Health Australia
Mumbai, India
Role:
< Collated and entered medical data obtained from various
hospitals and dispensaries.
< Reviewed entered data for any discrepancies.
< Performed quality checks by use of medical dictionaries and
other medical software's available.
< Coded the data through proper coding procedure provided.
< Analyzed and managed the quality of the data.
< Weekly meeting with team members on the improvement of the
service line.
< Maintained the weekly report & reported to manager for any
enhancement required.
Medical Representative
October 1999-December 2001
Doshi Hospicare,
Mumbai, India
Role:
< Promoted pharmaceuticals to Physicians.
< Periodic meeting with chemists & druggists.
< Resolved issues involving product availability and quality service.
< Increased business demand, regular discussions about new product
requirements with dealers & sales team.
< Conducted field sales analysis to determine status of account
activity.
< Carried out market research and customer surveys to assess demand,
brand positioning and awareness.
< Identified and promoted the introduction of new products to identify
high-end/low-end markets.
< Created promotional marketing strategies to boost sales through off
side tent sales events.
< Managed budget analysis for products and maintained check on
inventory.
Accomplishments:
< Increased product line sales and managed company's accessories.
< Played an integral role in the company's on-going success as a
product distribution leader.
Project Officer
August 1999-September 1999
WHO project-"Rational use of Drugs"
Seth G.S. Medical College & Hospital.
Mumbai, India
Role:
< Visited hospitals, met doctors, patients discussing medicines
assigned for existing medical condition.
< Checked medicines given and explained regarding about its
proper usage.
< Counseled patients for safe and effective use of medicines.
< Maintained daily report of patient's number, health conditions
and drugs assigned.
< Discussed with doctors about alternate drug suggested for the
particular health status.
< Collected appropriate data regarding current health issues.
< Coordinated with team members analyzing the data collected &
reporting to manager.
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ACADEMIC BACKGROUND
1 Post Graduate Diploma in Clinical Research,
Academy of Clinical Excellence (ACE), Bombay College of
Pharmacy, Mumbai, India
1998. Bachelors in Pharmaceutical Sciences.
Principal K. M. Kundnani College of
Pharmacy, University Mumbai, Mumbai, India.
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POSTERS & PUBLICATIONS
Publications
1. Singh N, Dubey S, Chinnaraj, S, Golani A, Maitra A. Association with
Plasma Isoniazid concentration
in a cohort of tuberculosis patients. Molecular Diagnosis and Therapy
13 (1), 49-58, 2009.
2. Singh N, Golani A, Patel Z, Maitra A. Transfer of Isoniazid from
circulation to breast milk in lactating women on chronic therapy for
tuberculosis. British Journal of Clinical Pharmacology 65 (3), 418-
422, 2008.
Poster presentations
1. N.Singh, A. Golani, J.Kanojia, S. Babu, C. Saravanan, A. K. Roygaga,
V. Salvi,
Z. Patel and A.Maitra- "Association of NAT2 Genotype with Transfer
Pattern of Isoniazid from circulation to Breast Milk in Lactating
Women on Therapy" in a International Symposium on Emerging Trends in
Genomic and Proteomic Sciences, 2006, Mumbai, India.
2. A. Golani, C.Sarkar-"Intellectual Property Rights and Drug Discovery
Regime" in a National conference- Environmental Technology: Biological
Perspectives Issues and Challenges, 2006, University of Mumbai.
3. N. Singh, Z.Patel, V. Salvi, A. Golani, J.Kanojia and A. Maitra-
"Genotyping of NAT2 polymorphism in a randomly selected Indian
population: It's association with Isoniazid metabolism" in a
International Symposium on Human Genomics and Public Health and 31st
Annual conference of ISHG, 2006, National Centre of Applied Human
Genetics, School of Life Sciences, JNU, New Delhi.
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AWARDS & CERTIFICATIONS
MAKRO You Shine Award, Best Performer
Good Clinical Practices: National Institute on Drug Abuse (NIDA), NIH, USA
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COMPUTER FORTE
Operating Systems: Windows 9X/2000/XP
Applications: Microsoft Office (Word, Excel,
PowerPoint)
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PERSONAL DETAILS
Language skills English, Hindi, Sindhi, Marathi
Self Like to take challenges; strive
consistently to achieve personal & professional goals
Excellent communication, presentation
and interpersonal Skills.
Ability to take up responsibilities
and deliver timely results.
Ability to cope under stressful and
difficult conditions.
Highly achievement oriented with a
positive attitude.
Interests Traveling, Photography, Drawing & Painting
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REFERENCES
Available on request