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MAYEE
Mobile: +91-9850162465 | E-Mail: rmayee@gmail.com
Seeking senior level assignments to unfold career opportunities in the areas of Research &
Development (Clinical Research & Pharmacological Research) with high growth oriented
research organization.
Professional Synopsis
A well experienced professional with over 15+ years of experience in Research & Development,
Knowledge Management, Project Management & Execution, Teaching and Administration.
Abilities in undertaking R & D initiatives, optimising resource, capacity utilisation & operational
efficiencies to meet deadlines and work under pressures.
Exposure in planning and organizing day-to-day research activities and resolving procedural problem as
appropriate to the timely accomplishment of research objectives.
An esteemed academician having the distinction of being associated with numerous Seminars,
Presentations, Workshops for, Talk Invitations, Conferences as well as publishing of a plethora of
Articles & Research Papers.
Exercises judgment within generally defined practices in applying scientific methods & techniques in an
innovative way for obtaining research solutions.
Honoured with a certificate of appreciation for ISO 9001: 2000 by Department of Bioinformatics
and Biotechnology in 2009
An effective communicator with excellent relationship management skills & strong analytical, problem
solving & organisational abilities.
Core Competencies
Executing research projects for development of new products, up gradation of existing products &
processes and conducting application trials.
Planning, monitoring and controlling of new projects for analytical approach.
Ensuring execution of the project within the set timelines; preparing & maintaining complete
documentation of the project within the set timelines for analytical approach.
Monitoring execution of the project within the set cost and quality targets.
Career Scan
Mar’ 16 to July 2016 with Quintiles as Sr. Clinical Process Specialist (Site Management)
Support CL to develop Clinical Operations Plan (COP) using DTE-specific template, and study-specific
documents, including: Monitoring Plan, SDV Plan and Study Reference, Manual/Guidelines/Instruction,
annotated Site visit report and letter templates, scripts for remote monitoring visits and telephone
contacts as applicable; Coordination with PDT for development of Various tools, templates, plans and
training material; Ensure the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM.
Request site monitor resources for site selection visits. Verifies training compliance and system access for
the site management team involved during the study start-up; Review Project Ownership Accountability
(POwA) within functional areas and annotate for changes or clarifications as needed per exception process;
Support CL to develop Data Delivery/ Monitoring strategy including monitoring triggers/thresholds. Help
develop Subject Level Data Review Plan and Data Segmentation Plan; Manage internal and external
system access for Quintiles and study site teams; Verifies that all Helplines/toll free numbers have been
requested and activated as per scope by each operational lead as appropriate (e.g. Helpdesk lead (EDC),
PCC lead (PCC involvement) or QCC); Support CL to Develop and provide (e) CRF Completion Guidelines
Aug’13 to Feb’16 with Om Sai Clinical Research Pvt Ltd, Sangli as HOD (Quality Assurance)
Responsible for the Clinical Quality Assurance functions of the organization reporting to the MD. Ensuring
planning, coordination, control, and continuous improvement of processes and methods are established to
control the quality of studies conducted at OSCR. Lead a team focusing on continuous improvement
projects using approved tools, design control, validations, and ensuring adherence to the agency
regulations, GxP, Industry Guidelines, local regulations, along with OSCR policies and procedures for the
conduct of clinical trials. This involves working closely with Clinical and analytical Operations, Information
Technology, stat and other supporting areas/development teams, to help ensure active participation in
continuous quality improvement activities
Support Continuous Improvement program through management of issues to ensure accurate root cause
analysis, corrective/preventive action implementation and confirmation of effectiveness.
Author Quality Assurance/Regulatory Affairs standard operating procedures as required. Assist with the
development and implementation of department specific Standard Operating Procedures.
Assist with the hosting and management of client audits. Analyze observations identified and generate
effective responses.
Perform routine quality reviews of key documents defined by OSCR related to:
Change Control
System Requirements
Testing/Validation Records
Installation Qualification
System Maintenance Records
Migration Records
Nov’06-Oct’09 with VedDoc Clinical Research Services Pvt. Ltd., Aurangabad as Project
Manager
During my experience with VedDoc, I got involved in clinical trials belonging to two major therapeutic
areas, Seasonal Fungal Infection, mental depression and diabetes. The study on the patients with fungal
infection was Phase II study (dose determination) for the sponsors from overseas and depression and
diabetes studies were for Indian MOH submission. The two studies on diabetic patients were Phase 1B and
Phase III. All the three studies were multi centric and conducted across the Nation. I had been involved in
the protocol development, study documentation development, investigator selection, feasibility
assessment, and budget negotiation with the investigators, ethics committee submission, planning the
clinical trial material procurement (study specific), planning the monitors visit at the site, continuous
coordination with the sponsors, dealing with the regulatory affairs department, maintaining the study files
etc. The team of two project coordinators and two Phase III CRAs were reporting to me for these trials.
Jun’04-Oct’06 with Synchron Research Services Pvt. Ltd. Ahmedabad as Senior Project
Coordinator (Department of Project Management)
SOP preparation and reviews for the project management department.
Drafting and Reviewing Clinical Study Protocol. All Bioequivalence and bioavailability studies and
Phase 1B, II and III clinical trial protocol development, getting the inputs from the expertise both in
house and sponsors’, getting the protocol QA audit done and resolving the audit issues, if any, were
the major responsibilities.
Submission of Investigator’s Package to Ethics committee. Submission of the protocol and the study
related essential documents (CRF / ICF), planning the IRB, incorporate the IRB recommendations,
communicating the IRB decisions to the stake holders were the major responsibilities.
Planning the Project.
Scheduling:
To assign tasks to team members
To define how the team will work together
To define the communication plan
To set up necessary tracking system
To announce the project
Performing:
To compare performance with plans with respect to:
Outcomes produced
Scheduled achievement
Resource expenditure
Deviations
Fixing problems that arise like changing task schedule or resources to get back on track
Communication with stakeholder
Closing:
Get approval/confirmation of the final results
Close all project accounts and finish up outstanding paperwork
Help people move on to their next assignment
Hold a post-project evaluation with the team.
Feb’02-Jun’02 with OHM Labs, New Jersey, USA as Junior Research Scientist (Dept. of Process
Validation & Technical Support)
Provided the assistance to the Scientist, PDTS department, Ohm Labs and completed the report on the
Process Validation and its Statistical Significance as a component of Evaluation in the course of Masters of
Pharmacy.
Education Details
Training on Safety Data Management by Helix Research Center Pvt. Ltd., Hyderabad in 2005
Training and Certification for membership by Indian Society for Clinical Research in 2008
Research Publications
Rahul Mayee, Ana Nikalje; “MORE Chemistry: An Eco-Friendly Technology”, National Conference on
Hydro- chemical, Biochemical and Environmental Pollution, 2002.
Rahul Mayee, Laila Fatima, Ana Nikalje; “Pharmacy Students: What they want?” APTI- 2003.
Mayee R, Rawat S; ‘Pharmacokinetic Studies of Topical Formulations – A Review’, Int. Jou. Of
Pharmaceutical and Clinical Research’, 2010; 2(3): 98-100.
V. A. Arsul, R. Mayee, S. A. Bhale; “Development Of Ultraviolet Spectrophotometric Method For
Determination Of Diclofenac Sodium In Stratum Corneum By Tape Stripping Method”, International
Journal Of Current Research And Review, Sept 2010; Vol: 2 Issue 9: 23-28.
S. S. Rawat, R. V. Mayee, V. A. Arsul; “Validation of Ultraviolet Spectrophotometric Method for
Determination of Diclofenac sodium in human stratum corneum by Tape stripping method using
different dermal products”, International Journal Of Current Research And Review, December 2010; Vol:
2 Issue 12: 25-31.
Mayee R, Rawat S; ‘Dermatopharmacokinetic Approach to Evaluate and Compare the Pharmacokinetic
Profile of Marketed Preparations of Diclofenac Sodium’, Int. Jou. Of Pharmaceutical and Clinical
Research’, 2011;3(1): 01-04.
Mayee R, Rawat S, Atre K, Mane P; ‘Evaluation Of Effect Of Pressure And Temperature On The
Bioavailability Of Marketed Formulation Of Diclofenac Gel’, Int. Jou. of Medical and Pharmaceutical
Sciences, March 2011;1(2): 1-8.
Mayee R, Rawat S, Atre K, Mane P; ‘Comparison between Marketed Formulations of Diclofenac Gel,
Emugel and Spray for the Evaluation of Effect of Pressure and Temperature on Their Bioavailability’, Int.
Jou. Of Pharmaceutical and Clinical Research’, 2011;3(1): 15-20.
Mayee R, Rawat S; ‘Evaluation Of Effect Of Pressure And Temperature On The Bioavailability Of
Marketed Formulation Of Diclofenac EmuGel’, International Journal Of Current Research And Review,
May 2011; Vol: 3 Issue 5: 23-30.
Mayee R, Rawat S, Thosar A; ‘Evaluation Of Effect Of Pressure And Temperature On The Bioavailability
Of Marketed Formulation Of Diclofenac Sodium’, Indo Global Journal Of Pharmaceutical Sciences, 2011;
Vol:1 Issue 2: 134-141.
Mayee R, Rawat S, Thosar A, Atre K, Mane P, ‘Development and Validation of HPLC Method for
Determination of Diclofenac Sodium by Tape Stripping Method’, Asian J Pharm Biol Res Apr-Jun
2011;1(3):260-265.
Mayee R, Rawat S, Thosar A, ‘In Vitro and In Vivo Investigation of Topical Formulations of Diclofenac
Sodium’, International Journal of Universal Pharmacy and Life Sciences September-October 2011;
1(2):45-55.
Rahul M, Swati R, Ambrish T; Invitro Penetration Study of Diclofenac Sodium Using the Human Cadaver
Skin, International Journal of Institutional Pharmacy and Life Sciences September-October 2011;
1(2):57-62.
Mayee R, Rawat S, Thosar A, Atre K, Mane P; ‘Adverse Event Reporting For A Dermatopharmacokinetic
Study of Diclofenac Sodium Topical Formulations’, International Journal of Pharmaceutical Research
2011; 2(9): 185-187.
Mayee R, Thosar A, Kondapure A; ‘Evaluation of Hepatoprotective activity of the leaves of Nyctanthes
arbor-tristis linn’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2010; 2(3): 109-111.
Prafulla Mane, Kavita Atre, Rahul Mayee; “Comparison Between The Pain Relieving Action Of
Serratiopeptidase, NSAIDS And Combination of Both In The Root Canal Treatment Patients”,
International Journal Of Current Research And Review, January 2011; Vol: 3 Issue 1: 11-17.
Rahul Mayee, Ambrish Thosar, Arun Kondapure; “Evaluation of Antiasthmatic Activity Of Calotropis
Gigantea Roots”, Asian Journal of Pharmaceutical and Clinical Research, April 2011; Vol: 4 Issue 2: 33-
35.
Prafulla Mane, Rahul Mayee, Kavita Atre; “Medicinal Properties of Allium Sativum (Garlic): A Review”,
International Journal Of Pharmaceutical Research and Development, April 2011; Vol: 3 Issue 2: 145-150.
Mayee R, Thosar A; ‘Evaluation of Lantana camara Linn. (Verbenaceae) for Antiurolithiatic and
Antioxidant Activities in Rats’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2011; 3(1): 10-14.
Mayee R, Thosar A; ‘Evaluation of antibacterial activity of Moringa oleifera against some bacterial
strains’, International Journal of Current Research and Review, April 2011; Vol: 3 Issue 4: 69-75.
Kavita Atre, Rahul Mayee, Sanjay Toshniwal; ‘Phenotyping an Overview’, International Journal of Current
Research And Review, May 2011; Vol: 3 Issue 5: 56-63.
Mane P, Bhosale D, Thosar A, Mayee R, Atre K; ‘Pharmacovigilance Study of Disulfiram Using Patients
With History Of Alcoholism’, Int. Jou. of Medical and Pharmaceutical Sciences, April 2011;1(3): 16-27.
Vilas A. Arsul, Supriya R. Wagh, Dr. Rahul V. Mayee; ‘Hepatoprotective Activity Of Livergen, A Polyherbal
Formulation Against Carbon Tetrachloride Induced Hepatotoxicity In Rats’, Int. Jou. Of Pharmacy and
P’Cal Sci’, 2011; 3(3): 228-231.
Prafulla Mane, Ambrish Thosar, Kavita Atre, Rahul Mayee; ‘The Need of Pharmacovigilance of Disulfiram
- A Review’, International Journal Of Current Research And Review, June 2011; Vol 3(6): 92-97.
Pardeep Kaur, Farough Ahmed, Poorvi Sharma, Prafulla Mane, Kavita Atre, Rahul Mayee; ‘Lichen Planus:
A Review’, Int. Jou. of Universal Pharmacy and Life Sciences, July-August 2011;1(1): 155-162.
Priyanka Wankhade, Prafulla Mane, Kavita Atre, Rahul Mayee; ‘To Study The Status Of Anaemia In Young
Female Population Of Aurangabad Region’, Int. Jou. of Medical and Pharmaceutical Sciences, June
2011;1(4): 1-7.
Poorvi Sharma, Pardeep Kaur, Farough Ahmed, Prafulla Mane, Kavita Atre, Rahul Mayee; ‘Population
Based Clinical Observational Study of Autoimmune Disorder Lichen Planus’, Int. Jou. of Institutional
Pharmacy and Life Sciences, Sept-Oct 2011;1(2): 19-23.
Sandeep S Lahoti, S G Shep, Rahul V Mayee, S S Toshniwal; ‘Mucoadhesive Drug Delivery System: A
Review’, Indo Global Journal Of Pharmaceutical Sciences, 2011; Vol:3 Issue 2: 243-251.
Santosh Shep, Sham Dodiya, Sandeep Lahoti, Rahul Mayee; ‘Swelling System: A Novel Approach
Towards Gastroretentive Drug Delivery System’, Indo Global Journal Of Pharmaceutical Sciences, 2011;
Vol:1 Issue 3: 234-242.
Charuvind K. Awale, Rahul Mayee; ‘Acetylator Phenotype in drug metabolism Relevant to
Pharmacogenomics and Pharmacogenetics Sciences: - an Overview’, Int. Jou. of Pharmacy Research
and Technology, 2011;1(2): 08-11.
Charuvind Awale, Kavita Atre, Rahul Mayee; ‘Phenotyping Study of Nat Enzyme Using Isoniazid as
Substrate in Maharashtra Population’, Int. Jou. of Pharmacy Research and Technology, 2011;1(2): 22-26.
Shinde PV and Mayee RV, “Development and Evaluation of Press Coated Tablet of Aceclofenac”,
International Journal of Pharmaceutical Innovations, Volume 2, Issue 1, Feb 2012, 6-15.
Shinde PV and Mayee RV, “Development and evaluation of press coated tablet by using rupturable
material (EC) combined with erodible material (klucel EXF) of Aceclofenac”, International Journal of
Pharmacy, 2(2), 2012, 380-385.
Shinde PV and Mayee RV, “A review: Current reported technologies used in pulsatile drug delivery
system”, International Journal of Pharmacy Review and Research 2012, Vol 2, Issue 1, 23-30.
Shinde PV and Mayee RV, “Development and evaluation of floating pulsatile release tablet of
Aceclofenac”, International Journal of Pharmacy & Technology, Vol. 4, Issue 1, April-2012, 3869-3877.
Shinde PV and Mayee RV, “Evaluation of pulsatile release of Aceclofenac tablets of the swelling, and
rupturable layers of hydrophobic polymer Eudragit RSPO and RLPO combination”, International Journal
of Advances in Pharmaceutical Research, Vol. 4 , Issue 1, Jan-2013, 1338 – 1342.
Shinde PV and Mayee RV, “Development of pulsatile release of Aceclofenac tablets with swelling and
rupturable layers of ethyl cellulose”, Asian Journal of Biomedical & Pharmaceutical Sciences (AJBPS),
Volume 2, Issue 15, 2012, 20-24.
Shinde PV and Mayee RV, “Evaluation of floating press-coated pulsatile release of Aceclofenac tablets
by using various proportion of polymers such Hydroxypropyl methylcellulose (HPMC K 15 M and HPMC K
100 M)”, International Journal of Pharmaceutical Research and Development, Vol 4(11), January 2013,
73-82.
Ambarish Thosar and Dr. Rahul Mayee, “Effect Food On Pharmacpkinetics Of Drug”, Journal of GMP and
Industrial Pharmacy, Vol. 7(1), February 2013, 53-57.
Vijay Pawar and Rahul Mayee, “Development and Validation of Hplc Method For Determination of
Dapson And Monoacetyl Dapson From Humal Plasma”, Journal of GMP and Industrial Pharmacy, Vol.
7(1), February 2013, 7-12.
Vijay Pawar and Rahul Mayee, “Phenotyping Study of Drug Metabolizing Enzyme NAT Using
Maharashtra Population Using The Probe Drug Dapson”, International Journal of Universal Pharmacy
and Life Sciences 3(2): March-April 2013, 23-32.
Shivdas Dhas and Rahul Mayee, “Phenotyping Status of The Drug Metabolizing Enzyme CYP3A4 Using
Atorvastatin As Substrate In Maharashtra Population”, IJUPLS, 3(2): March-April 2013, Page number: 11-
22.
Shivdas Dhas and Rahul Mayee, “The Need of CYP3A Enzyme Family Phenotyping: A Review”, Journal of
GMP & Industrial Pharmacy, 7(1): February 2013, Page number: 46-52.
Deepak Patil and Rahul Mayee, “Food Effect On Bioavailability of Drugs: A Review”, IJIPLS, 3(1): March-
April 2013, Page number: 1-19.
Deepak Patil and Rahul Mayee, “Effect of Food On Pharmacokinetics of Clindamycin”, Journal of GMP &
Industrial Pharmacy, 7(1): February 2013, Page number: 26-38.
Thakkar A and Mayee R, “Evaluation of Topical Bioavailability of Methyl Salicylate Using
Dermatopharmacokinetic Method”, IJUPLS, 3(2): March-April 2013, Page number: 1-10.
Thakkar A and Mayee R, “In Vitro and In Vivo Investigation of Topical Formulations of Methyl Salicylate”,
Journal of GMP & Industrial Pharmacy, 7(1): February 2013, Page number: 40-45.
Personal Dossier