Faisal Roohi

Past

Project and Business Development Manager at Metrics Research
Regional Manager at Kriger Research Group International
Biochemistry Specialist at J.A.C.L Clinical Laboratories

Senior Clinical Data Analyst at Oncology Therapeutics Network (Bristol-Myers Squibb)
Senior Clinical Data Analyst at Bristol-Myers Squibb
Research Coordinator at U.S. ONCOLOGY
Medical Technologist I at Quest Diagnostics

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Education

Kriger Research Center
University of North Texas

Recommended

4 people have recommended Faisal

Connections

54 connections

Industry

Research

Websites

Faisal Roohi’s Summary

– Certified Clinical Research Professional and active member of Association of Clinical Research Professionals (ACRP) and International Biopharmaceutical Association (IBPA)

– Project Manager for Clinical Trials Research at Metrics Research (first CRO of Pakistan)

- Lead CRA for Phase III Orthopedic trial - Coagulation Study (Kendle)

- CRA for Phase III PID study (Apex Parexel International)

- Project Manager for HLA-matched transplantation for thalassemia major: A project to support stem cell transplant in Pakistan per FACT -JACIE (ISCT & EBMT)

- Project Manager for Seven Treatment Evaluation Registry (STER) to collect information on current diagnostic and therapeutic management of F7 deficiency patients

- Also, Regional Head of Trainings on ICH –GCP through Kriger Research Group International (KRGI) for Central Asia including Pakistan, Iran, Afghanistan, Sri Lanka and Bangladesh

- Instructor on ICH GCP at Bahria University in Karachi (Summer School, 2008)

- Obtained double Bachelors degrees in Biochemistry and Microbiology from University of North Texas in the United States

- Gained clinical research experience at Baylor University Medical School in Dallas, Texas while working on oncology trials for US Oncology and later joined Oncology Therapeutics Network (a Bristol-Myers Company) in San Francisco

Faisal Roohi’s Specialties:

Mutliple project management skills: Lead monitoring team and site assistance/guidance, budgets and contracts formulation, regulatory submissions, protocol editing and writing, planning site initiation meetings, site feasibility/ investigator selection, recruitment and retention strategies, internal auditing for QA, SOP development and vendor selection

ICH GCP trainer

Business Development skills - Promoting Pakistan as the next EME

Faisal Roohi’s Experience

Project and Business Development Manager

Metrics Research

(Research industry)

June 2006 — September 2009 (3 years 4 months)

Responsibilities include site coordination, team guidance and oversight of all clinical site management activities including management of the protocol conduct, budgets, contracts, data collection and review,internal audits, and coordination of all related communication. Accountable for facilitating, tracking, and monitoring the progress of assigned site activities by maintaining close contact with site and team personnel.

Lead Clinical Research Associate (Lead CRA) – International Phase III Study.

Clinical Research Associate - Phase IIIb study multicenter trial

Project Manager for HLA-matched transplantation for thalassemia major

Project Manager for Seven Treatment Evaluation Registry (STER) to collect information on current diagnostic and therapeutic management of F7 deficiency patients

Quality Assurance and Auditing (2 years)

ICH GCP Trainer at Bahria University + web-based trainings
Regional Manager

Kriger Research Group International

(Privately Held; 11-50 employees; Research industry)

June 2005 — June 2006 (1 year 1 month)

Kriger Research Group International - Central Asia launched together with Metrics Research.

Marketing and promoting professional development training programs to clients associated with Pharma, clinical research, academic institutions both private and independent, professionals and students for various positions in the pharmaceutical industry.
Provide training that offer industry specific knowledge and skills and practical clinical trial experience. These programs are designed to provide training in ICH GCP, GLP, cGMP guidelines, investigative site coordination, knowledge and understanding of Food and Drug Administration (FDA) and Therapeutic Products Directorate (TPD) regulations.
Biochemistry Specialist

J.A.C.L Clinical Laboratories

(Privately Held; 11-50 employees; Hospital & Health Care industry)

November 2004 — October 2005 (1 year )

Responsible for all analytical assays performed on the Hitachi 9020 analyzer pertaining to Biochemistry.
Responsible for a variety of clinical tests both chemistry and microbiology using ELISA kits, sickle cell microcolumn chromatography for HbA2; coagulation studies (PT, PTT, DS-Dimer, Lupus, WIDAL, and others.
Senior Clinical Data Analyst

Oncology Therapeutics Network (Bristol-Myers Squibb)

(Privately Held; 10,001 or more employees; BMY; Pharmaceuticals industry)

November 1999 — February 2002 (2 years 4 months)

Responsible for the daily processing, review, and maintenance of data in the Lynx Data Management System in accordance with departmental policies and procedures. Writing and maintaining queries and programming code necessary to ensure the cleanliness and integrity of data, as well as contacting sites to resolve data errors and inconsistencies. Finally, generate both internal and external reports, as well as developing internal departmental resources for data cleansing and reporting.
Identifying patterns, missing links, issues, and problems with ongoing refinement to maximize utilization of resources.
Researching scientific journals for the latest breakthrough developments in the field of Oncology and Clinical Research trials for new treatment protocols.
Attending international exhibitions such as ASCO marketing and promoting the LDMS product to Oncologists besides supervising, training, and support of new and existing analysts.
Senior Clinical Data Analyst

Bristol-Myers Squibb

(Research industry)

1999 — 2002 (3 years )
Research Coordinator

U.S. ONCOLOGY

(Privately Held; 5001-10,000 employees; USON; Research industry)

February 1998 — November 1999 (1 year 10 months)

Clinical research and treatment protocols to develop innovative approaches in the science of Oncology. A full range of trials (Phase I - III) involving new chemotherapy agents, immune therapy, gene therapy, radiation therapy, and new devices. Responsible together with a high-tech team of physician's and nurses in the molecular and gene therapy treatment protocols for Pfizer, Parke-Davis, Chiron Technologies, Otsuka, Schering-Plough, Onyx and Vical pharmaceutical companies in accordance with F.D.A regulations.
Knowledge and understanding in the application of Code of Federal Regulations (Title 21), Good Clinical Practice (GCP) , and International Conference on Harmonization Guideline for Good Clinical Practice (ICH).
Medical Technologist I

Quest Diagnostics

(Public Company; 10,001 or more employees; DGX; Hospital & Health Care industry)

August 1993 — May 1997 (3 years 10 months)

Experienced in various departments:

Department of Immunochemistry (RIA)
Department of Serology
HIV Department
Department of Microbiology and Virology

Faisal Roohi’s Education

Kriger Research Center

Diploma , Certified Clinical Research Professional , 2004 — 2004

ICH GCP professional training
FDA CFR Title 21, TDP, and EU Clinical Trials Directive
University of North Texas

Double B.S. , Biochemistry and Microbiology , 1994 — 1998

Activities and Societies:

Member, American Medical Technologists (AMT)

Additional Information

Faisal Roohi’s Websites:

Faisal Roohi’s Interests:

R&D, Emerging economies, Bus.Dev., GCP trainings, mentoring, project management, personalized medicine...skiing, swimming, racquetball

Faisal Roohi’s Groups:

Association of Clinical Research Professionals (ACRP)
International Biopharmaceutical Association (IBPA)
American Medical Technologists (AMT)

BIO International Convention
University of North Texas Alumni Association (UNT)
Good Clinical Practice
Pharmaceutical and Healthcare Professionals Worldwide Network - www.PharmaWorldNet.com
Pharma Connections Worldwide
Biotech & Pharma Professionals Network
Clinical World
GCRP- Group of Clinical Research Professionals
Pharma BD Professionals
CRA Network
Biorepository Hub
Partnerships with CROs
Clinical Trial Performance Spot
Clinical Project Managers Network
EXCLUSIVE BUSINESS GLOBAL PHARMA CLUB
GCP Training CONTENT