Faisal Roohi

Angestellt, Medical Operations Manager, Bayer

Karachi, Pakistan

Über mich

I graduated from the University of North Texas with a double bachelor’s degree in Biochemistry and Biology in 1998. Over the past 19 years, I have been actively involved with the pharmaceutical, CRO, and ARO industries in various clinical research-related roles such as medical operations manager, director, clinical research manager, clinical team manager, project manager, and ICH GCP trainer. This professional exposure led to the development of a variety of capabilities that in most cases have proven even more valuable than the specific training I have had such as proficiency in monitoring, project management, operations, budgets and contract negotiations, line management, auditing, conducting ICH GCP and research methodology training, business development, clinical site management, data management, QA (SOP development), and medical writing. I attribute my successes to having worked with a diverse team of professionals of various cultural backgrounds from the US, Singapore & Pakistan.

Fähigkeiten und Kenntnisse

Projektmanagement
operations
budgets
contract negotiations
line management
monitoring
site management
data management
QA (SOP) development
medical writing
Klinische Studien
MS Office
Medidata Rave
Oracle Clinical
Redcap
InForm
IVRS
Cascade
Forecaster
Focus
Internal Audit
ICH
GCP Requirements
MS-Project
GxP
Klinische Forschung

Werdegang

Berufserfahrung von Faisal Roohi

  • Bis heute 9 Jahre und 3 Monate, seit März 2015

    Medical Operations Manager

    Bayer

    Pharmaceuticals Clinical Development Medical Affairs

  • 1 Jahr und 4 Monate, Dez. 2013 - März 2015

    Director Clinical Research and Operations

    Metrics Research Pvt Ltd

    Sets strategic direction and leads clinical trials through entire life-cycle Author and/or work with others to develop publications based on the results of the clinical trials/studies in conjunction with Medical Director Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure best clinical research practices

  • 10 Monate, März 2013 - Dez. 2013

    Clinical Research Manager

    PharmEvo Pvt Ltd

    Medical Writing (preparation of protocols, synopsis, ICFs, CRFs, clinical trial agreements and providing support with clinical report writing) Line management(CRAs and project assistants) and trainings (monitoring, AE reporting, team communication, CRF writing, budget control and site relationship building) ICH GCP and Research Methodology trainings(protocol, synopsis and dissertation writing; epidemiological research methods) at institutions and hospitals nationwide

  • 10 Monate, März 2012 - Dez. 2012

    Clinical Team Manager

    Pharmaceutical Products Development (PPD)

    Manage the execution of project deliverables within contractual timelines and client expectations, Provide leadership, coordination, and management of the company-customer joint project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities among others

  • 2 Jahre und 7 Monate, Sep. 2009 - März 2012

    Clinical Project Manager

    Singapore Clinical Research Institute

    Spearheading the 1st investigator initiated (IIT) global H&N cancer network trial involving 20 centers and advanced hepatocellular cancer study among others. Managing regional CRAs, facilitating steering committee meetings and offering proposals and recommendations’, liaison with network investigators, site selection, newsletter preparation, responsible for study and protocol updates budgets, SIVs, SOP development and other CTM related tasks. Provide trainings in project management

  • 3 Jahre und 4 Monate, Juni 2006 - Sep. 2009

    Project Manager

    Metrics Research

    Responsibilities include coordination and oversight of all clinical site management activities including management of the protocol conduct, data collection and review, and coordination of all related communication. Accountable for facilitating, tracking, and monitoring the progress of assigned site

Ausbildung von Faisal Roohi

  • 3 Jahre und 11 Monate, Aug. 1994 - Juni 1998

    Biochemistry and Microbiology

    University of North Texas

    Immunology Virology Cancers

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Gut

  • Französisch

    Grundlagen

Interessen

Reading
Running
Gardening
Social work

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