Amit Mahendru has nearly 8 years of experience in clinical research and quality assurance. He has worked at companies like Sun Pharma, PATH, and Ranbaxy Laboratories conducting clinical trials, monitoring sites, drafting documents, and ensuring compliance. Currently he is seeking a project management role in clinical research with a reputable organization.

1. AMIT MAHENDRU
Mobile: 09654-111255/ 0124-2218921 ~ E-Mail: whizkid282005@gmail.com
Dynamic professional seeking assignments in Project Management (Clinical Research) with an organization of high
repute
PROFILE SUMMARY
A versatile professional with nearly 8 years of experience in Research & Development, Clinical Trials and
Quality Assurance
 Holds 2 years of experience in Sales and Marketing
 Skilled in undertaking research initiatives, optimizing resource, capacity utilization & operational efficiencies to meet
deadlines under pressure
 Proven expertise in clinical trial monitoring, protocol review & data validation plan
 Extensive experience in conceptualizing & implementing SOPs
 Experience in designing / streamlining processes / procedures to facilitate robust Quality Management Systems
 Adept in conducting inspection, taking stringent quality measures & capably organizing quality awareness
programs in the organization
 An effective communicator with excellent analytical and problem solving skills
CORE COMPETENCIES
Clinical Trials
 Formulating the long / short term plans and SOPs to enhance the operations
 Selecting sites and conducting study qualification visits for the purpose of assessing their ability for trial
 Monitoring clinical trial sites and coordinating the drafting of protocol
 Ensuring proper storage, dispensation & accountability for clinical trial supplies at study site
Research & Development
 Organizing day-to-day research activities and resolving procedural problems as appropriate for the timely
completion of research objectives
 Writing/ reviewing detailed reports explaining about quality & results of research conducted and creating relevant reports
Quality Assurance
 Taking stringent quality measures including preparation of necessary documents to ensure compliance with standards
& customer’s requirements
ORGANISATIONAL EXPERIENCE
Since Jan’15 Sun Pharma Ltd., Gurgaon as Research Scientist (Medical Writing)
Key Result Areas:
 Drafting of Regulatory Documents to support worldwide drug dossier filings.
 Regulatory Documents includes:
 Prescribing Information
 Summary of Product Characteristics
 Patient Information Leaflet
 Expert Reports: Clinical, Non Clinical, Medical Data Package
 Medical Write-ups
 Assistance in preparation of responses to regulatory body queries
 Literature search for product evaluation
 Drafting of Newsletter
 Maintenance of Safety Update Recommendation Grid from PSUR/ Medwatch Alerts.
Dec’10 to Dec’14 PATH, New Delhi as Project Officer (Clinical Trials) - Clinical Operations Management Office
Key Result Areas:
 Accountable for clinical study set-up and follow up study activities through ongoing tracking
 Preparing the Progress Report and forwarding the same to Project Director & Project Coordinator of Clinical
Operations Management Unit (COM)
 Recognizing the quality issues within the study through regular evaluation of clinical documents that include
supervision of visit reports, data flow information and quality assurance audit findings

2.  Providing support at the COM Unit in carrying out day-to-day operational activities with the contract research
organization(s)
 Evaluating proposals and liaising with the vendors for ascertaining effective project management
 Accountable for updation of Tracking Systems for ensuring follow up on project timelines
 Handling the ongoing scientific review of clinic trial data during various trials
 Supporting in development of plans and their implementation for meetings and teleconferences
Highlight:
 Significantly managed end-to-end projects in clinical trials with patients / subjects ranging to 6800
Nov’07 to Dec’10 Ranbaxy Laboratories Ltd., Gurgaon as Quality Assurance Manager
Growth Path/ Deputations:
Aug’09 to Dec’10 Quality Assurance Manager at Gurgaon
Nov’07 to Aug’09 Regional Monitor – Phase III & IV studies at Ranbaxy Clinical Centre of Excellence, Amritsar
Key Result Areas:
As Quality Assurance Manager:
 Accountable for revision and maintenance of quality manual of the department
 Handled the preparation (QA SOP’s), evaluation, distribution and withdrawal of SOPs
 Carried out Induction Training for new joinees
 Organized GCP, SOP and Study Specific Trainings for MACR Staff
 Prepared individual training records/file of MACR Staff
 Efficiently supported & performed Audit for Phase II, III of clinical trials/studies undertaken by MACR Department”
 Performed the following:
o Internal as well as External Site, Clinical Database & Vendor Audits for ascertainment of sponsor SOPs and
applicable regulatory requirements
o System Audit of drug store facility and archival facility as per predefined schedule or as applicable
 Offered guidance and training on GCP compliance issues
 Forwarded monthly report to the senior management that focused on matters that required attention
As Regional Monitor – Phase III & IV studies at Ranbaxy Clinical Centre of Excellence, Amritsar:
 Involved in establishment of:
o Clinical Centre
o Data Bank of over 70 potential investigators of different specialties throughout Punjab
 Data Bank of Laboratories with facilities of clinical trial
 Accountable for development of a Schedule Y Compliant Institutional Ethics Committee
 Handled the site feasibilities for about 20 different sites of potential investigators
Major Researches conducted:
 Efficacy and Tolerability of Intravenous Administration of Investigational product in Complicated UTI and
Pyelonephritis
 Efficacy and Tolerability of Intravenous Administration of Investigational product in the treatment of Euvolemic
Hypernatremia. A multi centric, open label, non-comparative, phase III study
 A multi centric open label Phase III study to evaluate the safety and efficacy of investigational product in patients with
relapsed or refractory low grade or follicular Non-Hodgkin’s Lymphoma
Highlight:
 Accredited for setting-up the division from scratch
Jun’07 to Nov’07 Quintiles Research Center Pvt. Ltd., Mumbai as Clinical Research Coordinator - Phase III &
II studies under Neurology Department
Major Researches conducted:
 Efficacy, safety andtolerability of investigational productas monotherapy inpatients with early stages of Parkinson’s disease
o This is a Multicenter, international , Phase III , placebo-controlled, double-blind, randomized, parallel-group study to
assess Efficacy, safety and tolerability of study medication as monotherapy in patients with early stages of Parkinson’s
disease
o Primary Objective: to provide six months pivotal efficacy data to show the study medication is superior to placebo
with respect to the effect on motor functioning of Parkinson’s Disease patients
o Study centers: 100 in approximately 20 countries
o Number of patients: 330 subjects ( 110 subjects in each treatment group) having highest recruitment in India
o Expected study duration 16 month

3.  Efficacy and safety of investigational product in patients with Psychosis associated with Parkinson’s disease
o This is a Multicenter, international , Phase II , placebo-controlled, double-blind, randomized, parallel-group study
o Primary Objective:Efficacy, andsafety of study medicationin-patients with Psychosis associatedwithParkinson’s disease
o Study centers: 35 sites in 16 countries
o Number of patients: 90 subjects with highest recruitment in the world
o Expected study duration 2 months
 Efficacy, safety and tolerability of two doses of investigational product as add on therapy in patients with Idiopathic
Parkinson’s disease with motor fluctuations who are currently receiving a stable dose of levodopa and who may be
receiving concomitant with a stable dose of Dopamine agonist and /or an anticholinergic
o This is a Multicenter, international, Phase III, placebo-controlled, double blind, randomized, parallel-group
o Number of patients: 600 subjects.
o Expected study duration : 81.5 weeks
 Efficacy and safety of study medication once daily as adjunctive therapy in treatment of refractory Epilepsy, subjects 12
to 70 years with partial onset seizures
o A Multicenter, international, Phase III, placebo-controlled, double blind, randomized, parallel-group. Duration for
the study is 22 weeks
 Efficacy, safety and tolerability of investigational product in Levodopa treated Parkinson’s disease patients with
motor fluctuations
o A Multi centre, phase III, randomised, double blind, placebo controlled, parallel group study with 692 numbers of
patients. Duration of study is 26 weeks
PREVIOUS EXPERIENCE
Mar’05 to Aug’05 German Remedies Pvt. Ltd., Amritsar as Marketing Executive
Mar’04 to Mar’05 Macleod Pharmaceutical Ltd., Amritsar as Primary Sales Officer
Sep’03 to Mar’04 Panacea Biotech, Hoshiarpur as Marketing Executive
SPONSOR AUDITS ATTENDED
 Sponsor audited the site for:
o A Multicenter, International, Phase III, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study to
Assess Efficacy, Safety and Tolerability of Study Medication as Monotherapy in Patients with Early Stages of
Parkinson’s Disease
o A Multicenter, international, Phase III, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group to Know
Efficacy, and Safety of Study Medication Once Daily as Adjunctive Therapy in Treatment of Refractory Epilepsy,
Subjects 12 to 70 years with Partial Onset Seizures
o Multicenter, International , Phase II , Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of
Efficacy and Safety of Investigational Product in Patients with Psychosis Associated with Parkinson’s Disease
TRAININGS
 Attended ICH-GCP Training at Quintiles Research Centre, Mumbai in 2007
 Undergone 82 hours of training in a Program for Learning Key Topics like Leadership, Business Communication, Body
Language, Customer Care, Negotiation Skills, Holding Successful Meetings, Time Management at Arjun Academy,
Amritsar in 2008
IT SKILLS
 Conversant with MS Office and Internet Applications
INDUSTRIAL VISITS
 One day visit at:
o Preclinical Study Site, INTOX Pune
o Phase I Unit of VEEDA Ahmedabad
EDUCATION
2007 PG Diploma (Pharmaceutical Management) from Institute of Clinical Research, Mumbai
2003 Bachelor of Pharmacy from SBS (PG) Institute, Dehradun, CCS University, Meerut
Other Course:

4. 2007 Certificate Course in Clinical Research from Institute of Clinical Research, Mumbai, United
Kingdom Cranfield University
PERSONAL DETAILS
Date of Birth: 28th July, 1981
Permanent Address: 153, Sri Vas Aangan, S.G Enclave, VPO Pandori, Waraich, Amritsar – 143001
Present Address: A5/904, Tulip White, Sector – 69, Gurgaon-122001, Haryana
Languages Known: English, Hindi and Punjabi