MAHESH L. PATIL, Project ManagerTel No.: +91-09821413182E-mail Id : patilmahesh1983@yahoo.co.in

Career Objective :

To get recognized in the industry I work for my good knowledge, working skills, hard work and sincerity. I would like to be a part of an organization where there is impetus provided for all round development & where sincerity, self commitment & hard work is appreciated.

Educational Qualification :

Class Year University Institute GradeMSc. inClinical Research

2004-06 Dr. M.G.R University, Chennai.

Institute of clinical research (India)

First Class

B.Sc (Micro Biology) 2003-04 Mumbai University M.V.L.U.College First ClassH.S.C 2000-01 Maharashtra Board Cosmo politian

collegeDistinction

Professional Experience :

Total Experience: - 9 Years and 5 monthsRoles performed and responsibilities handled in 9 years and 5 months’ experience: -

Project ManagementFunction HeadMonitoring Visits Co-monitoring Visits / Quality Visits Site initiation Visits Site Close-out VisitsRegulatory SubmissionsBudget Management – 15 Projects & entire Clinical Operations FunctionPerformance Management – 2 Clinical Project Leads, 2 Clinical Research Associates, 1 Clinical Trial

AssistantUpdating knowledge in difference therapeutic areas – Oncology, Rheumatology, Diabetes, Respiratory

Company, Roles and Responsibilities: -

Boehringer-Ingelheim India Pvt. Ltd.

Project Manager – May 2012 – Till dateReporting to – Head of Clinical OperationsReportees –Indirect reportees working on the project

Responsibilities: -

Responsible for initiation, execution, management and completion of assigned clinical projects –

Phase Indication

Phase III Diabetes – Type 2 Diabetes Mellitus

Phase III Oncology – Acute Myeloid Lymphoma

Phase III Respiratory – Chronic Obstructive Pulmonary Disease

Roche Products (India) Pvt. Ltd.

2. Assistant Manager Clinical Operations (Country Study manager) - Jan 2010 – Apr 2012Reporting to – Director, Medical AffairsReportees – 2 Clinical Project Leads, 2 – Clinical Research Associate, 1 Clinical Trial Assistant

3. Senior Clinical Research Associate - Mar 2009 to Dec 2009Reporting to - Director, Medical Affairs

4. Clinical Research Associate - March 2008 to Feb 2009Reporting to Director, Medical Affairs

Responsibilities: -

Responsible for initiation, execution, management and completion of phase II-IV local, regional and global registration clinical trials

Phase Indication

Phase II Oncology -Triple Negative Breast Cancer

Phase III Oncology -Gastric Cancer, Ovarian Cancer, Breast Cancer, Lymphoma (DLBCL)

Immunology – Rheumatoid Arthritis

Phase IV Oncology – Gastric Cancer, Renal Cell Carcinoma, Non-Small Cell Lung Cancer

Nephrology – Chronic Kidney Disease

Virology – Hepatitis C and Hepatitis B

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Responsible for evaluating feasibility of conducting global registration studies in India Negotiate contracts, streamline working and manage all respective vendor like Study

document archival, clinical trial supplies, study document development, data management, CRO, central labs, investigator sites for the smooth conduct of all in-house as well as outsourced studies

Budget management of Clinical Trials Coordination with other departments like logistic, legal, finance, regulatory and product

team to discuss the strategies on budget allocation for overall clinical operations function and planning of new studies.

Coordination with regulatory team for submission of initial and ongoing dossier to DCGI and DGFT.

Assisting Quality Assurance function to improve on Local SOP as per local regulations CTMS for internal employees and e-CRF trainer for Site staff Faced one Global audit with no major findings

SIRO Clinpharm India Pvt. Ltd.-

Clinical Research Associate - Feb 2007 to March 2008 Reporting to: - Clinical Project Manager and Head Clinical Monitoring

Reposibilities: -

Site selection, Site initiations, site trainings on protocol, GCP and local regulations, site monitoring and site close-outs of allocated sites in Phase I/II, II and Phase III studies planned for DCGI, US-FDA and EMEA submissions in Oncology and Rheumatology.

Details of trial Indication Submission Achievement

Phase – II Global Multicentre and multinational Study

4 sites

Oncology - Glioblastoma

1) US-FDA

2) EMEA

Completed re-filing of all the study specific documents as per the sponsor’s refilling plan and transferred all the documents to sponsor as per the plan.

Phase III Global Multicentre and Multinational Study

2 sites

Rheumatoid Arthritis

US-FDA Successful Audit by External Quality assurance to check ICH-GCP, Regulatory, SOP and protocol compliance.

A Phase 1/2, Global, Multicenter Study

5 sites

Oncology – Breast Cancer

US-FDA Site initiation, FPI at all initiated sites and monitoring – as per the timelines agreed with sponsor

Manage DCGI, DGFT and EC submissions for allocated sites and studies Keeping the track of number of patients recruited, and patients completed follow ups as

per protocol in specified period of time.

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Keeping all the documents inspection or audit ready Faced sponsor audit successfully with no major findings

Sanofi-Aventis India Pvt. Ltd.

Clinical Research Associate - Aug 2006 to Feb 2007 Reporting to – Clinical Research Manager

Responsibilities: -

Site selection, Site initiations, site trainings on protocol, GCP and local regulations, site monitoring and site close-outs of allocated sites in studies - Details of trial Indication

Global Multicentre and multinational Study

10 sites

Diabetology

Global Multicentre and Multinational study

5 Sites

CNS

Manage DCGI, DGFT and EC submissions for allocated sites and studies Keeping the track of number of patients recruited, and patients completed follow ups as

per protocol in specified period of time.

Macleods Pharmaceuticals Limited, Mumbai

Clinical Research Associate, Clinical Section - January 2006 to August 2006 Reporting to – Head Clinical Section, Bioequivalence Department

Responsibilities –

To assist in clinical operations during clinical pharmacokinetic studies and other clinical studies

Organize screening of prospective study subjects To liase with an accredited pathology and x-ray laboratory for proficiency testing of

biological parameters To assist the protocol team in the preparation of the protocol. To obtain informed consent from study subjects To compile and assist in the analysis of raw data and its archiving To assist the clinical head in the preparation of the clinical report of all studies

conducted To write and revise SOPs as per need and maintain awareness and adherence to all

current SOPs. Operating the Volunteer Database Software

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Conceptual Knowledge :

GCP, Schedule Y, Clinical Development Process, Clinical Project Management, Clinical data management, Regulatory aspects of Clinical Trials, Monitoring, Protocol Development, Informed Consent, Biomedical Ethics & various other aspects of Clinical Trials

Computer Skills :

1. Ms-Office : Ms-Dos, Ms-word, Ms-Powerpoint, Ms-Excel & 2. Basic Internet operating course.3. Electronic Data Capture – InForm V4.6, Rave, Oracle Clinical4. Clinical Trial Management System (Siebel)

Affiliations : Affiliate Member of The Institute of clinical research, UK

Date of Birth : 19TH AUGUST 1983

Linguistic Proficiency : English, Hindi, Marathi (Spoken and written) References : Dr. Bhaswati Mukherjee

Associate Director – Medical Affairs Sanofi – Aventis India Pvt. Ltd.Contact no: +9-9820691591.

Dr. Vinod PatilHead – Clinical OperationsGeorge Institute (India)Contact no: +9-9908080689

Contact: 13, Prabhat Housing Society, Raje Shivaji Nagar,Saki-Vihar Road, Powai, Andheri(East). Mumbai- 400 072.

Place: Mumbai Mahesh Patil

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