Global Clinical Trials Project Manager

Prateek Mehra

Global Clinical Research professional

Skills, abilities & contributions in Career

** ***** ** ********** **** Lean & Six Sigma certification.

Currently, working as Freelancer Global Clinical Project Manager supporting GCPM ‘s Globally since 01 Mar 2016.

Last worked as Global Clinical Project Manager, Clinical Operations, Hospira, India for All Hospira Phase II-IV, IIS & Registry studies globally.

Successfully given transition of Studies and Processes to Pfizer Inc from Hospira end.

13 years in the Clinical Research Industry with various global CRO’s and MNC Pharmaceutical’s and 4 years as a research scientist at CDRI, Lucknow (GOI organization)

~11 years of start – end Global Clinical Project management of multinational trials across INDIA, APAC, ANZ, JAPAN, MENA, AFRICA, USA, Europe i.e. Global Phase I-IV, PMS, Observational, Registries & IIS/IIR/IIT studies for various IND, ANDA, Investigational Molecules, Marketed Drugs and many Biosimilar’s drugs.

Hands on experience with many EDC systems and clinical trial management systems.

Understanding of Global Clinical Research Process. Scientific therapeutic background to comprehend to study & protocol.

Attention to details, demonstration of problem recognition and problem-solving abilities. Knowledge of regulatory requirements with ICH-GCP, & GXP guidelines for Drug Manufacturing, Drug Discovery, Clinical research and post marketing studies.

Project Managing an approved/awarded study from client, organization, within budget and deliverables perspective [starting from strategic management to build a Project Charter [RFP to submission of agreed finalized study output (study report, etc within scope, timelines, resources and budget parameters].

Mentoring the orientation of team on deliverables, client, cost and organization parameters to ensure smooth business conduct and leverage for future growth on confidence sharing basis.

Resourcing based on the finalized budget (awarded study) in conjugation with Functional heads (Department Manager) based on business need keeping in view with agreed awarded study FTE count, to ensure optimized, timely deliverable to client and profitability for organization.

Developed new high-quality investigator sites in India by providing training on local regulatory and ICH GCP guidelines in addition to providing extensive trial conduct feedback to both internally for organization/teams and associated vendors.

Experienced with conduct of Phase I-IV, PMS, IIS/IIT & BA/BE studies (Global Project Managers/Clinical Studies / Pharma & CRO’s / Vendor / Study Team / investigator site team) management. Starting from feasibility, site selection, Client / investigator / site / per patient budget finalization, site initiation, regular monitoring, site close-out visits with final deliverable, per project budget & scope of work submitted to client).

M.Sc.

Master in Microbiology, University of Rajasthan, Jaipur

2004

B.Sc.

B. Sc. (Chemistry, Zoology & Botany), MDS University, Ajmer

2002

Certification

Lean & Six Sigma Certification by Annexa Denmark. Hospira India

2015

Certification

Advanced Excel trained professional from Coalesce. Hospira, India

Nov 2014

Certification

Clinical Foundation Program Certified as Clinical Research Associate, PPD, Singapore.

2008

Certification

Clinical Research Certification, YCCP, RCRS, Navi Mumbai,

2006-07

●Oncology

Phase II Hepatocellular Carcinoma

(Monoclonal Antibody, light sensitivity)

Phase III Glioblastoma Multiforme’s

(Glucose Analog V/S radiation)

Phase III Non-Small Cell Lung Cancer

Phase III Renal Cell Carcinoma,

Phase III Platinum - sensitive Ovarian

Cancer in First Relapse (monoclonal

Antibody with Taxane therapy)

Phase II Metastatic Renal Cell Carcinoma

Phase II Metastatic HNSCC

●Endocrinology

Phase III DM

Phase III DM with Cardiovascular endpoints

●Cardiology

Phase III & IV non-valvular atrial fibrillation

●Dermatology

Phase III Complicated Skin & Skin

Structure Infections (CSSSI)

●Ophthalmology

Phase III Ophthalmic Lens Implant Study

●Orthopedics

Phase III Osteoarthritis Study

●IIS and Registry Studies for Biosimilar’s in

Psoriasis

Oncology

Cardiovascular/Oncology/Brain/Lungs/Renal Surgeries

●Psychiatry

Phase I Psychiatry

Phase II Adolescent schizophrenia

Phase II Major Depressive Disorder

Phase III Adolescent schizophrenia

Phase III &IV Open label PK study in schizophrenia

●Vaccines

Phase III & IV DTaP + Hep B vaccine study in Children

●Infectious Disease

Phase III MRSA infection study

Phase III Complicated Intestinal Infections (CITI)

Phase III Complicated Urinary Tract Infections (CUTI)

Phase III & IV Ulcerative Proctitis

Phase III MDR-Tuberculosis

●Wound Healing

Phase III Wound Healing (Burns) Study

Phase III Wound Healing (DFU) Study

●Surgeries/ Medical Devices

Phase III Primary Inguinal Hernia (mesh)

Phase III Hemorrhoid Stapling

●IIS and Registry Studies for Biosimilar’s in

Sedation

Burns

Devices

RA

IBD (Crohn’s & UC)

Freelancer Global CPM_ (Working from Home since 1 Mar 2016 – Present and 1 Jul 2012 – 30 Sep 2014)

Responsibilities: As Global CPM, supporting my clients as freelancer for Project Management activities and mentoring internal resources.

Hospira India (6 Oct 2014 – 29 Feb 2016): Global Clinical Project Manager, Hospira Global. (Majorly Work From Home with travel for work, due to Global responsibility and oversight in different geographies and time zones) Responsibilities: Global CPM: Responsible for mentoring many global CPM’s and working as Global CPM for all Investigator initiated studies and Registries at Hospira (a Pfizer company).

Directly mentored and supported many GCPM’s, Medical Science Liaison’s and Study Functional Teams.

Tracked ongoing clinical studies as GCPM with respect to organization SOP’s, applicable regulations, protocol and study budget spend and reporting all global studies updates to senior & strategic management on monthly and as management need basis.

M D S University, Aimer / Department of Microbiology & Biotechnology (AD-HOC basis from July 2004 – May 2006 & from Jul 2012 – Sep 2014) and (01 Mar 2016 –present) Lecturer on AD-HOC. Job Description: Coordination of Departmental Activities, Lecturing, Job Placement activities, Design & Installation of Biotechnology & Microbiology Laboratories & equipment’s, Trainer for Quality management & Bio Ethics.

Jubilant Clinsys Ltd. (24 Jan 2011- 19 Jun 2012): Global Clinical Project Manager (Associated CPM, worked from home with Global responsibility & oversight)

Responsibilities: As GCPM led a matrix-based management module with cross-functional study team reporting; managed contractors/vendor’s, all-study-related data, central laboratories and study enrollment targets. Directly supervised clinical research associates and conducted training. Generated study documents, including protocol, informed consent forms, case report forms, monitoring guidelines and project specific documents.

Ensured data quality and compliance by routinely participating in co-monitoring activities and mentoring CRAs and study team members assigned to a specific project.

Recognized for effectively managing study budget and timeline commitments.

Presented to investigators and clinical staff at Investigator Meetings to ensure proper training and understanding of the clinical trial process and protocol.

Built effective physician relationships by representing the company to Key Opinion Leaders (KOL) and clinical investigators

PPD, International. (Jan 2008 – Dec 2010) : Senior Clinical Research Associate, New Delhi.(Worked from home due to Global responsibility)

Responsibility: Works as Back up to Project Manager / Clinical Team Manager. In respect to relationship with Clients, team handling and various aspects of management

●Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs.

Reliance Clinical Research Services Pvt. Ltd. Aug 2006 – Dec 2007: CRA & CTL, Navi Mumbai.

Responsibility: Works as Back up to Clinical Project Manager as a Clinical Team Leader. In respect to relationship with Clients, team handling and various aspects of management

●Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and RCRS SOPs.

Central Drugs Research Institute (CDRI), Lucknow / Department Of Microbiology / Parasitology (2002 – 2006)

Designation: Research Scientist: Responsibility: Designed quantification techniques based on immunological methodology (ELISA) for detection of Filariasis, Malaria & Leishmaniasis in the Department of Microbiology & Parasitology at CDRI, Lucknow.

Research Experience:

Indication of study / Disease

Study type and phase

Test Kit for incidence & quantification of Filariasis

Prospective study

Test Kit for incidence & quantification of Malaria

Prospective study

Test Kit for incidence & quantification of Leishmaniasis

Prospective study

Date of Birth : 15th November 1978

Marital Status : Married

Location Preferences : Open for relocation anywhere i.e. Local/International or remote (Home Based)

Permanent Address : Kothi Number 1, Kala Bagh, Ajmer – 305001 (Rajasthan)

Last Drawn CTC : 12,29,691 INR without variable

Mobile # : 91(0) 987-***-****

Email ID : **************@*****.***

Competencies

Education

Therapeutic Experience

Professional Experience

Personal Dossier

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