Clinical Trials Manager

DEEPAK C. PATEL

*** ******** **** **, *********, South Carolina- 29072, US.

Tel. No.: +1-839-***-****, E-mail: ***.*****@*****.***

Visa Status- L2S (includes EAD), Validity- 27 Jun 2024

Career Objective:

To maximize my potentials and utilize them effectively to attain organizational goals and objectives through positive attitude, flexibility and an open mindset. I also want to perform with diligence, honesty and result oriented. To enhance knowledge for my professional growth in the Clinical Trail and Pharmaceutical field and elevate to higher achievements in career and procure responsibilities that account on the basis of performance and diligent work.

Professional Experience and Expertise:

Total 15+ Years of experience in the field of Clinical Trials/Research

Project Management 505b(2) projects and Conduct of Clinical Trials / Bioavailability / Bioequivalence studies for Generic Drugs and 505b(2) products etc.

Investigator, Clinical Trial Site and Bio Study CRO Identification and Selection

Independent Facility/System Audit of Bio Study CRO

Independent Monitoring of Clinical Trials, Bioavailability, Bioequivalence studies

Independent Auditing of Clinical Trials, Bioavailability, Bioequivalence studies

Well versed with regulatory guidelines (ICH- GXP)

Handling of regulatory/sponsor audits

Training of personnel on ICH and Regulatory guidance

Project Timeline Management and Tracking

SOP preparation and training of personnel’s

Computer System Validations as per 21CFR- for software interfaced with HPLC, GC, GCHS-MS, Titrator, AAS, UV, IC, ICP-MS

Software Knowledge- User Management and Troubleshooting of 21CFR complaint software’s used in Analytical laboratory like Chromeleon, Tiamo, Qtegra etc.

Ethics Committee co-ordination for submission and approval of Clinical Study documents

Troubleshooting

Education:

Degree/Course

University/Institute

Year of passing

M.Sc. in Clinical

Research

Institute of Clinical Research (India), New Delhi, Dr. M.G.R. University, India

2006

M.B.A in Marketing

Institute of Clinical Research (India),

New Delhi, Guru Jambeshwar University, India

2006

B.Sc. (Chemistry)

Bhavan’s College, Mumbai,

Mumbai University, India

2003

H.S.C

Bhavan’s College, Mumbai,

Maharashtra State Board, India

2000

Professional Experience:

Organization

Position

Duration

Sichuan Credit Pharmaceutical Co. Ltd., Mumbai, India- Location

Clinical Trial Manager

Feb’ 2020 to Feb’ 2022

Fusion Scientific Laboratories Pvt. Ltd.,

Mumbai, India

Dy. General Manager,

Project Management

Mar’2012 to Jan’ 2020 date

Ashco Niulab Industries Ltd., Mumbai, India

Research Associate (RA)

Oct’2009 to Mar’2012

Research Support International Ltd.,

Mumbai, India

Research Associate (RA)

Nov’2006 to Oct’2009

Macleods Pharmaceuticals Ltd.,

Mumbai

Clinical Research

Associate (CRA)

Jan’2006 to Nov’2006

Job Description:

1.Sichuan Credit Pharmaceutical Co. Ltd. (Office location- Mumbai, India):

Clinical Trials / Bio-Study:

Project Management of BA/BE/Clinical Trials- start from submission/negotiation of quotes till submission of Final Clinical Study Report and submission to in-house regulatory department

BA/BE- CRO / Clinical Trial Site identification and selection

BA/BE- CRO- Facility and System Audit (Independent) for qualification and selection procedure

Clinical Study Designing: Designing, implementation, choosing participants, and scheduling study

Monitoring and Auditing (in-process and retrospective) of clinical studies outsourced to Indian CRO

Ensuring Bio Study CRO / Clinical Trial Site having necessary facilities/requirement for conduct of study

Before initiation of study ensuring all the necessary licenses are obtained, Innovator/Test products, standards, if any, are sufficiently available at CRO

Local Regulatory approvals from authorities like CDSCO- DCGI (India), Local – FDA, CDSCO (West Zone) for obtaining approval of NOC for Form- 29, Form- 29, Import licenses, BA/BE NOC etc.

Project planning and timeline management. Ensuring project timeline is followed and met by CRO for each stage of the study

Troubleshooting for the anticipated risk or risk arising during the conduct of clinical study at CRO

Document and present the progress of project and deliver the progress reports to the Management

Preparation, Review, Approval and Training of Standard Operating Procedure

Study Initiation and Close Out meetings

Supply of Investigational Products at CRO/Clinical site

Formulation Development Projects:

Project Management – 505b(2) projects for US-FDA submission. Pre-IND meeting, Contract Manufacturing, Protocol for BE study.

Execution of Project contracts/agreements with vendors in consultation with legal, financial department and assigning responsible matrix for conduct of project

Single point contact between CRO and RnD department - Analytical, Formulation for smooth execution of the project

Ensuring project initiation requirements are fulfilled before initiation of the project (like DMF, Technical documents, applicable license, Innovator Product, API, WS/RS, Impurities, Packaging/Tooling, analytical columns/methods, standards etc.)

Teleconferencing/Biweekly update meeting with CRO for project updates and respective dept./team members, providing updates and take necessary action on the discussed points.

Ensuring supply and import of required quantities of Innovator Product, API, Working/Impurity standards, columns etc. for the respective project

In co-ordination with department- identify the API vendors, Working/Impurity standards, excipients, tooling’s (punches), HPLC/GC columns, packaging materials etc. and its procurement as per the project requirement

Identify third party laboratory (ies) for outsourcing of analytical testing activities where facility is not available at CRO

To manage the import and custom clearance activities of the API/Innovator Products/working and impurity standards, columns etc. for the conduct of the formulation and analytical method development/validation activities.

2.Fusion Scientific Laboratories Pvt. Ltd., Mumbai:

Bio-Study:

Project Management activities right from submission/negotiation of quotes till submission of final report documents to Sponsor

Regulatory approvals from authorities like CDSCO- DCGI (India), Local – FDA, CDSCO (West Zone) for obtaining approval of NOC for Form- 29, Form- 29, Import licenses, BA/BE NOC etc.

Bio-Study CRO / Clinical Trial Site identification and selection

Bio-Study Designing: Designing, implementation, choosing participants, and scheduling study

Ensuring protocol/report writing and obtaining approval from sponsor, DCGI-CDSCO regulatory, IEC etc.

Monitoring and Auditing of clinical trial studies outsourced to Indian CRO by overseas clients

Ensuring Bio Study CRO / Clinical Trial Site having necessary facilities/requirement for conduct of study

Before initiation of study ensuring all the necessary licenses are obtained, Innovator/Test products, standards, if any, are sufficiently available at CRO

Ensuring project timeline is followed by CRO for submission of report/status update

Document the progress of project and deliver the reports to the management/sponsor

Preparation, Review, Approval and Training of Standard Operating Procedure / Regulatory guidance.

Study Initiation and Close out meetings

IT and System Administrator –

a.Computer System Validations as per 21 CFR- for software interfaced with HPLC, GC, GCHS-MS, Titrator, IC, ICP-MS etc.

b.Software installations, instrument connectivity management, user management and troubleshooting of Chromeleon, Tiamo, Qtegra software etc.

Formulation Development and Analytical Projects:

Execution of Project contracts/agreements with Sponsor/vendors in consultation with legal, financial department and assigning responsible matrix for conduct of project

Single point contact between Sponsor and various departments at Fusion like QA, ADL, FD.

Ensuring project initiation requirements are fulfilled before initiation of the project (like DMF, Technical documents, applicable license, Innovator Product (RLD), API, Working/Reference Standards, Impurity Standards, Packaging/Tooling, analytical columns/methods, standards etc.)

Teleconferencing with clients for weekly/monthly project updates along with respective dept./team members, providing updates and take necessary action on the discussed points.

Ensuring supply and import of required quantities of Innovator Product, API, Working/Impurity standards, columns etc. for the respective project

In co-ordination with department- identify the API vendors, purchase of required quantities of API (on behalf of sponsor), Working/Impurity standards, excipients, tooling’s (punches), HPLC/GC columns, packaging materials etc.

Identify third party laboratory (ies) for outsourcing of testing activities for which facility is not available with FUSION

To manage the import and custom clearance activities of the API/Innovator Products/working and impurity standards, columns etc. for the conduct of the formulation and analytical method development/validation activities.

3.Ashco Niulab Industries Ltd., Mumbai, India:

Project Management activities right from preparation, submission of protocols and reports to sponsor, planning of conduct of studies and providing regular project updates to sponsor.

Preparation, Review, Approval and Training of Standard Operating Procedure to study personnel’s

Regulatory approvals from authorities like CDSCO- DCGI (India), for obtaining approval of Import licenses, BA/BE NOC etc.

Study Designing for Generic Drugs, 505b(2) applications- study outline, washout period, time points etc. in co-ordination with the PI and the Biostatistician for faster execution of final protocols.

Protocol Preparation (protocol summaries, protocols of pilot and pivotal studies)

Preparation of Informed Consent Form / Informed Consent Document with simplification of technical words.

Conduct of studies- Bioequivalence and Bioavailability Studies – Generic drugs, 505b(2) applications.

Follow-up with the sponsor for review of the protocol and incorporation of any suggestions in the protocol.

ICH guidelines and SOP Training to study personnel

Responsible for carrying out literature search and design the study protocol

4.Research Support International Ltd. (subsidiary of DIL Group), Thane, India:

Project Management and Study Conduct –

a.Conduct of Bioequivalence study at selected CRO’s for Generic Drugs.

b.Conduct of Clinical Trials for 505b(2) application, new dosage forms, new indication, new strength of already approved molecule

Responsible for study supplies are made available to Clinical Trial Site and CRO like investigational products, IB, Subject Information Sheet, ICDs

Ensuring necessary licenses are obtained by CRO prior to shipment of investigational products and prior to study conduct.

Monitoring of Clinical Trials, BA/BE Study activities starting from Project Initiation till report submission – for Generic drugs, 505b(2) applications.

Auditing of Clinical Trials, BA/BE Studies right from Protocol preparation till report submission- for Generic drugs, 505b(2) applications

Ensuring patients/subject compliance as per protocol requirement

Periodic updates on the ongoing projects to the Sponsor

Regulatory approvals from authorities like CDSCO- DCGI (India)- Import licenses, BA/BE NOC etc.

Literature search on study molecules and design the study protocol

Protocol preparation and finalization in co-ordination with selected CRO for submission to Sponsor

Auditing of Clinical Data and final reports for submission to sponsor for further submission to regulatory agency

Interim review of the CROs

5.Macleods Pharmaceuticals Ltd., Mumbai, India:

a.Management of clinical operations during clinical pharmacokinetic studies (BA/BE studies)

b.Organizing screening of prospective study subjects

c.Communicating with an accredited pathology and X-ray laboratory for proficiency testing of biochemical parameters

d.Obtaining informed consent from study subjects

e.Preparation of Standard Operating Procedures

f.Preparation of Protocol, ICF for review and approval of Dept. Head

g.Maintaining volunteer database and check for accurate and complete details of volunteer.

h.Maintaining safety parameters of volunteers during study participation

i.Assisting the clinical head in preparation of clinical reports of the conducted study

j.Compilation and checking/QC check of CRF with source data and its archiving

Seminar Attended:

Attended Workshop on “Biowaivers as in-vivo surrogate, basic concepts of in vitro-in vivo correlation (IVIVC) & Understanding statistical outcome of BE studies through examples for non-statistics” on 25th and 26th Jan. 2014 organized by Pharma Edge Centre (I) Pvt. Ltd.

Attended the 16th International Seminar on “Global Clinical Trial Management and Logistics” to be held in Mumbai - India, on June 6th, 2008, at the Renaissance Mumbai Hotel & Convention Centre by World Courier

Attended Workshop organized by Arkus Clinical Trial Support Solutions and PharMantra Consulting Services on 9th and 10th May, 2008, Mumbai.

Theme: “Quality systems in Clinical Research”

Attended One Day Workshop cum Seminar organized by Pinnacle Healthcare on 05th April, 2007, Mumbai Topic: “Auditing BA/BE”

Attended first International Conference organized by Institute Of Clinical Research, (India) on 1st, 2nd, 3rd & 4th Dec’05 at INSA, New Delhi Theme: India’s Emergence As Hub For Clinical Research

Presentation:

Presented seminar on ‘Introduction of Pre-Study Monitoring Visit at the Trial Site’ under the guidance of Dr. Bhawana Awasthy,

Presented seminar on ‘Informed Consent Process in Clinical Research’

Regular presentation of every study results to management

Professional Achievements:

At Sichuan Credit Pharmaceutical Co. Ltd.

Project Management of 505b(2) projects

At Fusion Scientific Laboratories Pvt. Ltd.:

Active participation during US-FDA inspection

Active participation during ISO certification audit

At Ashco Niulab Industries Ltd.:

Active participation during audit of facility by Sponsor, NABL, ISO, WHO

At Research Support International Ltd:

Monitored/Audited around 14-15 Studies- Clinical Trials and Bioequivalence / Bioavailability studies

At Macleods Pharmaceuticals Ltd:

Faced WHO- Audit having role of presenting Bioequivalence study documents by Auditors and answering the queries on the documents

Active participation during conduct of 10-12 Bioequivalence Studies

Quality Control Check of 10-12 Bioequivalence Studies

During training period appointed as Project Co-ordinator for 4-5 Bioequivalence Studies

Computer Skills:

Having a very good command on Microsoft Office and Internet Surfing along with various aspects of computers fundamentals.

Eager to learn various software applications in the field of Clinical Trials, Pharmaceutical Research and Development

Computer System Validations for various analytical instrument software’s like Chromeleon, Qtegra, Tiamo etc.

Undergone Computer Training Program:

Obtained Certificate for “Office Assistant Course”, conducted during Jan-March’02 by Bhartiya Vidya Bhawan, Mumbai.

Completed certificate course in ‘Computer Hardware Maintenance with Internet, Networking & Multimedia’ conducted during the period 14th April’03 to 23rd May’03 by Government Polytechnic, Mumbai

Software Knowledge:

Chromeleon, Qtegra, Tiamo- User Management and Troubleshooting

Extra-Curricular Activities:

Obtained N.C.C. ‘A’ Certificate as a Flight Cadet in the Year 1997

Participated in ‘Walk-A-Thon’ Competition towards the construction of NASEOH’S NATIONAL SOCIETY FOR THE HANDICAPPED AND OTHER SERVICE PROJECTS and awarded certificate of Participation

Personal Information:

Gender : Male

Marital Status : Married

Nationality : Indian

Languages Known : English, Hindi, Gujarati, Marathi (written and spoken) Hobbies : Computers, Music, Traveling

Cell/Mobile No. : +1-839-***-****

Place :

Date : DEEPAK C. PATEL

Contact this candidate