Project Manager Medical

Dr. Gagandeep Vasudev, MBBS, PG., executive MBA

TORRANCE, CA ( +1-484-***-**** (

*********@*****.***

STATUS IN USA: LEGAL PERMANENT RESIDENT (GREEN CARD)

AN OVERVIEW

Gagandeep is a Medical Professional with over 13 years of experience in

Clinical Research, Medical Practice and IT - Lifesciences. Currently,

Gagandeep is working in the capacity of Site Director while running

multiple Phase I - IV clinical trials. Gagandeep also has extensive

experience supporting Project Management and Consulting activities related

to the Drug Safety, Clinical Development and Pharmaceutical Sales and

Marketing areas. His rich and unique mix of Pharma, Medical and IT

experience has helped provide valuable insights to his employers.

SPECIFIC EXPERTISE

. Site Director, responsible for Operations, Management and revenue

increase of the entire research facility

. Setup Satellite Sites, perform as monitor/ QC expert and coordinator;

assisted in regulatory submissions

. Provided a credible growth to the research unit, handled business

development and budgets

. Therapeutic Areas: Cardiology, Allergy, Asthma, ADHD, COPD, Device,

Vaccine, Cardiovascular. Has Medical Doctors background, hence

knowledgeable in other therapeutic areas like oncology, metabolism,

infectious diseases.

. Direct experience in handling of Protocol development, study feasibility,

facilitating Ethics Committee meetings, study initiation, handling of

Adverse Events, enforcing SOPs and Regulations, QC and Regulatory

documentation

. Experience as Senior Manager, IT Lifesciences with Project Management and

Pharmaceutical Consulting skills

. Thought leadership activities, development of new service offerings and

strategies in the Clinical Development area

. Client business relationship, project delivery experience (IMS Health,

Novartis, Abbott, Forest Labs, Daiichi-Sankyo)

RELEVANT SKILLS AND EXPERIENCE

Clinical Research and Site Director - Phase I to IV clinical trials, Clinical

Leadership Experience Operations, QC / Monitoring and Coordination activities, FDA

Audit preparation, Study Budgets, Patient recruitment

strategies, Study Initiation, IRB Handling, Trial Master

Files, Clinical Data Management, Safety and

PharmacoVigilance, Clinical Study metrics collection &

Reporting, Domain Expert/ SME - Life Sciences, CDISC,

Teaching experience

Therapeutic Areas Cardiovascular, Allergy, Asthma, ADHD, COPD, Device, Vaccine.

Has Medical Doctors background, hence knowledgeable in other

therapeutic areas like oncology, metabolism, rheumatology,

infectious diseases, sleep disorders

Business Development Operations using Metrics Dashboards & Revenue Tracking

and Operations including utilization optimization, preparation of

Go-to-Market themes, New Offerings development, Maintaining

Line of Business, Thought Leadership & Strategizing

activities

Project Management & Completed 48 hours of PMP training conducted by PMI

Consulting Tools certified trainers, MS Project, various templates for

effective Project Management & Process Consulting

Clinical Trial Tools Familiar with following Clinical applications:

and Applications Medidata Rave, Oracle Clinical, OC-RDC, ArisG, Argus, EMR /

EHR

Worked with client specific applications:

Sapphire tool for Adverse Event management, Abbios eECG for

ECG capture and diagnosis, PIMS for Phase I monitoring,

Quantum for clinical study budgeting and forecasting, DIMT

for managing Pharma promotional spends, NPS, PromoTrack and

New to Brand for Pharma Sales & Marketing Intelligence (IMS

Health)

Requirements gathering Microsoft Visio, MS Word, MS PowerPoint, MS Excel, Microsoft

and Other Tools Project. Reporting tools: Tibco Spotfire, Cognos, Documentum,

SharePoint & eRoom

PROFESSIONAL BACKGROUND

CALIFORNIA CLINICAL RESEARCH INSTITUTE

SITE DIRECTOR

September 2013 - Present 2013 (4 months)

Site Director / Partner for a Research Facility running Phase I to IV

Clinical Trials

. Setup a new research practice for a practice group (Cardiology,

Respiratory and Internal Medicine trials)

. Prepared new SOPs, Forms, Templates, Best Practices, conducted staff

trainings

. New Business Development, Clinical Operations and Management,

demonstrated revenue growth

. Setup Satellite Sites, performed as monitor/ QC expert and

coordinator; regulatory contact

PENINSULA RESEARCH ASSOCIATES, INC.

SITE DIRECTOR

November 2012 - November 2013 (1 year)

Site Director / Monitor / Experienced Coordinator for a Research Facility

running Phase I to IV Clinical Trials

. Clinical Operations and Management of the research unit, demonstrated

credible revenue growth

. Setup Satellite Sites, performed as monitor/ QC expert and

coordinator; regulatory contact

. Single-handedly prepared an extensive study metrics dashboard

dynamically reflecting the current activities, staff workload and

study projections. Provided credible growth of research unit

. Improvised process flows resulting in effective removal of

redundancies and SOPs

. Patient recruitment strategies; implemented Scrum methodology for

patient recruitment, used EMR / EHR

. Business Development activities, new Sub-Investigator on-boarding,

site selection and initiation visits

. Managed AE/SAE's, assisted in study budgets; IT and consulting support

and inputs as necessary

. Delivered guest lectures to MS - Clinical Research students at

university level

SUBJECT MATTER EXPERT / CONTRACTOR

CONSULTANT - CLINICAL DEVELOPMENT

March 2012 - November 2012 (8 months)

. Project Manager for a Clinical Data Repository development project

overseeing Scoping, Requirements and Design Activities (Amgen, CA)

. Project portfolio manager overseeing project pipeline, helping in high-

level requirements and estimates, SOW preparation, bringing the

projects to a logical start (Novartis, NJ)

COGNIZANT TECHNOLOGY SOLUTIONS

SENIOR MANAGER - IT LIFESCIENCES CoE

June 2007 - March 2012 (4 years and 9 months)

Note: Full time position with Cognizant, however, was placed as a

contractor at top tier pharmaceutical companies on consulting projects

. Project Management and Consulting activities in Clinical Development,

PharmacoVigilance and Pharmaceutical Sales & Marketing areas

. Worked in client projects in the capacity of project manager, domain

consultant or business systems analyst:

o Clinical Study Metrics Dashboard creation using Medidata Rave,

Cognos and CTMS (Abbott Vascular)

o eECG Software enhancements (Abbott)

o Phase I Monitoring System enhancements (Abbott)

o Study Budget Calculation & Forecasting Tool enhancements

(Abbott)

o Safety Data Reporting Tool selection and implementation project

using Tibco Spotfire (Abbott)

o Sunshine Act tool development project for the Ethics &

Compliance Division (Novartis)

o Project Manager-cum-Domain Expert for CDISC Study Data

Conversion Project (Forest Labs)

o Clinical Trial Master File process redefinition & optimization

(Daiichi - Sankyo)

. Worked as a part of the following Cognizant internal projects and

initiatives:

o Set-up and managed a team of Business Analysts / Consultants at

another client location (IMS Health) while being involved in

various strategic and development projects with the same client

o Cognizant's operational activities - managing utilization /

allocation issues and revenue tracking

o Prepared "go to market" themes, new business development

o Took reporting of 20 associates of Cognizant Business Consulting

group

o Delivered lectures while engaging with a PharmacoVigilance

certificate program run by Symogen

ALEMBIC LIMITED

HEAD, CLINICAL RESEARCH

August 2006 - June 2007 (10 Months)

Conducted numerous clinical studies on volunteers which involved

pharmacokinetic and bioavailability analysis.

. Planned, Approved and Conducted numerous Clinical Trials. Increased

productivity of the unit.

. Improvised various processes and systems in Clinical Research division

resulting in capacity increment

. Enforced GCP, SOPs and applicable regulatory requirements for study

conduct

. Medical care of Trial Subjects and Adverse Event reporting

. Prepared and Reviewed SOPs related to Clinical Research division

RANBAXY LABORATORIES LIMITED

SENIOR RESEARCH SCIENTIST

February 2005 - August 2006 (18 months)

Clinical Research position, reporting to the Head of Clinical Pharmacology

Unit.

. Organized, co-ordinated and conducted clinical studies

. Handled Ethics Committee meetings, study presentations for Ethics

Committee approvals

. Provided conceptual / medical inputs to the Discovery Working Groups

and the New Improved Chemical Entities Groups for new drug and

compound development

. Provided clinical and medical support to the Pharmacokinetic and

Bioequivalence (BA / BE) studies

. Analyzed clinical study data and prepared clinical reports

. Handled CRA queries - Monitoring and Quality Assurance audit teams,

helped prepare for FDA Audits

. Medical Screening of Subjects as a Licensed Physician, supervised

Adverse Events

HCL TECHNOLOGIES LIMITED

DOMAIN EXPERT

April 2004 - February 2005 (10 months)

Provided domain and conceptual inputs towards HCL's Life Sciences Practice.

Prepared white papers on clinical trial and data management, conducted

domain knowledge transfer tutorials. Evaluated complex healthcare software

AMGEN CANADA INC.

REGULATORY AFFAIRS ASSOCIATE (CO-OP POSITION)

June 2003 - September 2003

Assisted in SANDS preparation, worked on product monographs & information

for patients, New Drug Submission and CTA-amendments.

APOTEX RESEARCH INC.

INTERN, CLINICAL RESEARCH (CO-OP POSITION)

May 2002 - September 2002

Reviewed protocols and subject selection criteria. Maintained and actively

screened subject database, assisted in obtaining informed consents,

conducting pre-clinical medical examination and subject check-in for

clinical trials. Carefully analyzed & updated subject related information,

reviewed clinical study data, prepared clinical reports

RESIDENT DOCTOR with Private Practitioners

JUNIOR RESIDENT

January 2000 - July 2001 (19 months)

Note: Full time position, left for higher studies in Canada

Junior resident doctors are hired by institutions and private practitioners

to conduct various medical activities as directed. Performed evaluation of

patients, prescribed medicines and treatments, ordered and assessed

laboratory tests, created and maintained case records.

DAYANAND MEDICAL COLLEGE

DEMONSTRATOR - ANATOMY (TENURE POSITION)

February 1999 - December 1999 (11 months)

Worked as Demonstrator in the Department of Anatomy: Delivered lectures,

performed dissections on cadavers, conducted tutorials, assisted professors

in various teaching activities.

GOVERNMENT MULTISPECIALTY HOSPITAL

PHYSICIAN INTERN (TENURE POSITION)

January 1998 - December 1998 (12 months)

Performed clinical evaluation of patients, prescribed and administered

medication to various patients, ordered and assessed laboratory tests,

created and maintained case records

ACADEMIC QUALIFICATION/PROFESSIONAL CERTIFICATIONS

<

. Bachelor of Medicine, Bachelor of Surgery (M.B.B.S., considered

equivalent to the M.D. degree in the U.S. system) - Government Medical

College, Patiala, Punjab, India

. Postgraduate Certificate Course in Clinical Research - Humber College,

Toronto, Canada

. Postgraduate Certificate Course in Regulatory Affairs - Humber College,

Toronto, Canada

. Executive Program in Business Management (participation in one-year

course: 2008-09) - Indian Institute of Management, Calcutta

Trainings Attended:

. Completed 48 hours (44.5 PDU Credits) of PMP Certification Training

from PMI Certified Education Provider

. Two-day workshop on advanced Consulting Skills in New Jersey, USA

. Workshop on Business, Technical and Email Writing in Philadelphia, USA

. Clinical Data Management Trainings, Requirements Engineering and Bullet

Proof Manager Training at Cognizant

Training Conducted:

. Delivered guest lectures to MS - Clinical Research students at

university level

. Taught in the PharmacoVigilance course run jointly by Cognizant and

Symogen

PROFESSIONAL MEMBERSHIPS

<

Member, ACRP

STATUS IN USA

<

Legal Permanent Resident (Green Card) - can work for any employer without

need of sponsorship now or in future

APPENDIX 1 : LIST OF CLINICAL STUDIES MANAGED

<

Attention-Deficit/Hyperactivity Disorder (ADHD)

. Shire Development Inc.: A safety, efficacy, and tolerability study of a

drug in adolescents aged 13-17 years diagnosed With Attention-

deficit/Hyperactivity Disorder (ADHD)

. Shire Development Inc.: A safety and efficacy study of a drug, compared

to another product, with a placebo reference arm, in adolescents aged 13-

17 years with attention-deficit/hyperactivity disorder (ADHD)

. Shire Development Inc.: A safety and efficacy study of a drug in

adolescents aged 13-17 years with attention-deficit/hyperactivity

disorder (ADHD)

Allergic Rhinitis

. Merck: Safety study of a drug in house-dust-mite allergic adolescents

. Sunovian: A safety and efficacy study of a nasal aerosol in subjects 6-11

Years with Seasonal Allergic Rhinitis

Allergy Studies

. Circassia: A multi-center study to assess the efficacy and safety of a

new immunotherapy in cat allergic subjects

. Circassia: A multi-center, single-blind study to assess the safety of a

new immunotherapy in cat allergic pediatric subjects

Asthma

. Sanofi-Aventis U.S. Inc: Efficacy, safety, and tolerability study on

patients with persistent severe eosinophilic asthma

. GlaxoSmithKline: A safety and efficacy study on adolescent and adult

subjects with asthma

. GlaxoSmithKline: A 6-month safety and benefit study on paediatric

subjects 4-11 years old with persistent asthma

. GlaxoSmithKline: A dose-ranging study of an inhalation powder in children

aged 5-11 years with asthma

. GlaxoSmithKline: A multi-center study of the efficacy and safety of an

adjunctive therapy in subjects with severe uncontrolled refractory asthma

. Vectura Limited: A dose-ranging study to evaluate the efficacy and safety

of three strengths of a drug in adolescent and adult subjects with asthma

. Cephalon: Efficacy and safety study of a drug in patients with moderate

to severe asthma

. Array: Efficacy and safety of a drug in adults with persistent asthma

. Rigel Pharmaceuticals, Inc.: A Phase 2 study of two doses of an inhaled

drug in patients with mild to moderate allergic asthma

. Teva: Efficacy and safety and steady-state Pharmacokinetics of a drug

versus placebo in subjects 12 years and older with persistent asthma

. Amgen: A safety and efficacy study of a drug in subjects with

inadequately controlled asthma and high bronchodilator reversibility

. GlaxoSmithKline: A study on an adjunctive therapy in subjects with severe

uncontrolled refractory asthma

. Sanofi: A dose-ranging study to evaluate a drug in patients with moderate

to severe uncontrolled asthma

. TEVA: An assessment of the integrated dose counter on an inhaler

. TEVA: A single-dose, double-blind, double-dummy, placebo-controlled, five-

Period crossover, dose-ranging, efficacy and safety comparison study of a

combination HFA in pediatric patients with persistent asthma

. TEVA: Efficacy and safety study in adolescent and adult Subjects with

severe persistent asthma uncontrolled on high dose inhaled corticosteroid

therapy

. Novartis: A clinical trial to establish the efficacy of a combination

intravenous drug in asthma that is inadequately controlled with inhaled

corticosteroids and long acting beta agonists

. Novartis: A study examining the effect of orally administered compound on

FEV1 and ACQ in non-atopic, asthmatic patients with inadequately

controlled with low dose ICS therapy

. Sanofi: A dose ranging study to evaluate a drug in patients with moderate

to severe uncontrolled asthma

(Continued on next page

Cardiovascular

. An event-driven trial of weekly trial medication in the prevention of

recurrent cardiovascular events among stable post-myocardial infarction

patients with type 2 diabetes or metabolic syndrome

. A multicentre, international cardiovascular safety & renal microvascular

outcome with a test drug in patients with type 2 diabetes mellitus at

high vascular risk

COPD

. Novartis: Efficacy, safety and tolerability study of a compound in COPD

patients with moderate to severe airflow limitation

. Novartis: A comparison study in patients with Chronic Obstructive

Pulmonary Disease (COPD) who have moderate to severe airflow limitation

Device

. Gen-Probe Incorporated: a clinical evaluation of the an HPV Assay in

Women 30 Years of Age or Older With Negative Pap Test Results Using XXXX

Pap Test Specimens

Nasal Polyp study

. Sanofi: A study to evaluate a test drug in patients with bilateral nasal

polyposis and chronic symptoms of sinusitis

Vaccine

. Merck: An HPV related study on preadolescents and adolescents (9 to 15

year olds) with comparison to young women (16 to 26 year olds)

. GlaxoSmithKline: A vaccine study on young adults

. Novartis: A clinical study to evaluate the safety, immunogenicity and

efficacy of an adjuvanted quadrivalent subunit influenza virus vaccine

compared to non-adjuvanted comparator influenza vaccine in children ?6 to

< 72 months of age

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