Faisal Roohi

Experience

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  Quest Diagnostics

  Aug 1993 - May 1997

  Medical Technologist I

  Immunochemistry:Conducted efficient tests on various hormones, ferritin, immunoglobulins, digoxin and complements using ACS 180 and LKB Gamma CountersSerology:Conducted antibody testing for Hepatitis A, B, C, M, and E on the Commander platformHIV Department:Conducted qualitative analysis of HIV-1 antibodies in human serum or plasma utilizing the Microelisa system (Vironostika HIV-I).Performed HIV-1 Western Blot, an in vitro test to identify antibodies against specific HIV Type I proteins in serum or plasma of individuals identified as reactive in screening tests such as EIA.Conducted HIV-I Recombigen (env and gag) EIA, an in vitro enzyme immunoassay for diagnosing and screening potential HIV-I infection in blood donors and individuals.Used the RPR card test to identify syphilis antibodies in human serumMicrobiology and Virology:Utilized DFA testing to identify Herpes Simplex virus types I and II through detection of cytopathic effect (CPE)Conducted direct fluorescent monoclonal antibody tests on Chlamydia culturesUtilized the GEN-PROBE PACE 2 system for rapid DNA testing using nucleic acid hybridization techniques.Revised protocol for screening Chlamydia trachomatis and Neisseria gonorrhoeae infections.Conducted fat analysis on human fecal specimens using advanced techniques to assist in identifying malabsorption syndromesConducted qualitative detection of Clostridium difficile Toxin A in fecal samplesConducted Streptococcus A tests using Strep A latex method on patient samples.Engaged in continuous professional development to keep abreast of advancements in medical technology.Utilized Laboratory Information Management Systems LIMS for efficient data entry and management.Reviewed and validated test results before release to ensure accuracy and reliability.Trained junior medical technologists and laboratory assistants in proper laboratory practices.Managed inventory of laboratory supplies and reagents, reducing waste and ensuring availability. Show less

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  U.S. ONCOLOGY

  Feb 1998 - Nov 1999

  Research Coordinator

  Coordinated oncology clinical trials (Phases I-III) for US Oncology at Mary Crowley Cancer Research in Texas, gaining valuable clinical research experience with a focus on new chemotherapy agents, immunotherapy, gene therapy, radiation therapy, and devices.Managed and ensured compliance with FDA regulations while overseeing the implementation of molecular and gene therapy treatment protocols for Pfizer, Parke-Davis, Chiron Technologies, Otsuka, Schering-Plough, Onyx, and Vical pharmaceutical companies in collaboration with healthcare professionals.Received multiple sponsor awards for exceeding client expectations and demonstrating excellence.Facilitated effective communication between investigators, sponsors, clinical scientists, and CRAs to ensure the precise retrieval and clarification of clinical data from local and satellite investigator sites.Developed system to collect, analyze, and manage clinical data for ensured accuracy and reliability of patient files/charts and case report forms (CRFs)Created standard operating procedures and quality assurance methods.Facilitated new study opportunities by forging strong relationships between sponsors and investigators.Successfully analyzed laboratory reports, adverse events and drug reactions to identify major trends in clinical data.Proposed innovative techniques to boost efficiency and customer connections. Show less

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  Oncology Therapeutics Network (Bristol-Myers Squibb)

  Nov 1999 - Feb 2002

  Senior Clinical Data Analyst

  Led high-performing clinical data analysts in editing and coding treatment regimens for an estimated 50,000 cancer patients daily. Represented approximately 18% of national cancer patients for the Information services business line.Developed deep expertise in classifying treatment regimens through continuous monitoring of evolving treatment patterns in medical literatureFacilitated transition from manual paper coding to automated online system for data coding software development. Enabled OTN to shift from quarterly batch reporting to near real-time analytics.Utilized knowledge gained from attending international events like ASCO to promote the Lynx Data Management System (LDMS) to oncologists.Resolved customer queries and problems using effective communication and providing step-by-step solutions.Prepared range of written communications, documents and reports.Diffused challenging situations using conflict management techniques.Demonstrated consistent hard work and dedication to achieve results and improve operations.Demonstrated outstanding product knowledge to achieve high customer satisfaction levels. Show less

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  J.A.C.L Clinical Laboratories

  Nov 2004 - Oct 2005

  Biochemistry Specialist

  Conducted various biochemical tests using the Hitachi 9020 analyzerPerformed various clinical chemistry and microbiology tests, utilizing ELISA kits, sickle cell microcolumn chromatography for HbA2, coagulation assays (PT, PTT, D-dimer), Lupus tests, and WIDAL.Cultivated strong relationships with clients, stakeholders, and team members, building a culture of trust and cooperation.

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  Kriger Research Group International

  Jun 2005 - Sept 2009

  Regional Manager

  A concurrent role with Metrics Research from Jun 2006. Designed and conducted ICH-GCP training programs tailored for clients in the pharmaceutical industry, encompassing Pharma organizations, clinical research organizations, private and independent academic institutions, as well as aspiring professionals and students pursuing careers within the pharmaceutical sector.Equipped participants with industry-specific knowledge and practical clinical trial experience through trainingExperienced in ICH-GCP, GLP, and cGMP guidelines. Coordinated investigative sites and gained knowledge of US FDA and Canada's TPD regulations.Implemented customer service excellence, enhancing client satisfaction rates by 25%.Engaged with community and industry events to enhance brand presence and network opportunities. Show less

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  Metrics Research

  Jun 2006 - Sept 2009

  Senior Project Manager

  Assisted in the creation of research protocols as well as designing CRFsPrepared Investigator and PV agreements, patient information sheets, and PIC formsEnsured GSK Pakistan's preparedness for audits and inspectionsEvaluated site viability and recommended necessary improvements for successful trial executionsDeveloped effective strategies in response to sponsors' needs through creation of project plans and monitoring processes.Trained and mentored team members for boosting their inspiration towards achieving challenging deadlines while exceeding performance expectations.Optimized clinical trial operations through management of schedules, assignments, and staff allocationConsistently ensured trial progression by proactively identifying potential issues through contingency planning and forecasting.Identified trends and issues in regular study progress and monitoring reports, enabling prompt corrective action.Monitored investigator performance regarding conduct and enrollment, promptly addressing any concerns.Conducted regular staff training, performance reviews, and team-building activities to foster a proficient and motivated team that consistently met KPIs and KRAs. Show less

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  Singapore Clinical Research Institute Pte Ltd

  Sept 2009 - Mar 2012

  Project Manager II

  Project Manager II– Oncology and Infectious DiseaseIHN01 Trial– International Head & Neck Network TrialOversaw and ensured the smooth execution of the IHN01 Trial for the International Head & Neck Network.Coordinated and directed a multinational, first-of-its-kind clinical trial initiative in association with 30 global centers to explore and develop effective treatments for head and neck cancers.Led clinical trials for advanced hepatocellular carcinoma and dengue fever in diverse patient populations. Conducted studies to evaluate the safety and efficacy of new treatments, resulting in significant improvement in patient outcomes.Managed local and regional CRAs, organized steering committee meetings to propose and recommend improvementsLiaised with network investigators to select sites, prepare newsletters, and update studies/protocols, budgets, SIVs, SOP development, and other CTM-related tasksDelivered project management and GCP training to teamsAHCC07 Study– Liver Cancer Network TrialContributed to the AHCC07 Study for Liver Cancer Network Trial.Led a sponsored advanced hepatocellular oncology study involving four ASEAN countriesEdited the protocol and designed the Patient Information Sheet (PIS) along with informed consent formsCoordinated investigator and Site Initiation Visit (SIV) meetings.Prepared trial-related documents.ADEPT – Adult Dengue Platelet StudyLed a sponsored advanced hepatocellular oncology study involving four ASEAN countries.Edited the protocol, designed the Patient Information Sheet (PIS) and informed consent forms. Coordinated investigator and Site Initiation Visit (SIV) meetings. Prepared all trial-related documents.Prepared DSMB charter and agenda. Show less

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  PPD

  Mar 2012 - Dec 2012

  Clinical Team Manager

  Successfully managed project deliverables within contractual timelines and exceeded client expectations during various trial stages (start-up, recruitment, maintenance, closeout-database lock).Allocated clinical resources (CRAs/administrative team) to optimize efficiency and advance clinical deliverables based on projected needsEnsured timely communication and reporting of any tasks falling outside the project's scope to facilitate potential contract amendmentsTracked, reviewed, and distributed metric updates to external/internal clients/vendors.Created a contingency plan for reviewing clinical data listings and cleaning dataManaged the evaluation process of data listings by collaborating with clinical team.Developed a standardized train monitoring plan and implemented corrective and preventive actions (CRAs) to ensure regular monitoring during the trialDeveloped source documents, CRF/eCRF guidelines, and project-specific forms for use during the study periodImplemented comprehensive training programs to equip monitoring staff with the necessary knowledge and expertiseNegotiated recruitment budget at site levelPerformed secondary clinical review of case report forms to identify query trends and monitor re-education requirementsLed and coordinated joint PPD-customer project teams for seamless execution of all phases from start-up to closeoutManaged personnel hierarchy and evaluated employees in alignment with PPD's human resources policiesMonitored staff to review pass-thru travel costs and ensure cost-effective travel practices are utilizedEnsured team CRAs conducted and documented monitoring activities according to contractual obligations.Diffused challenging situations using conflict management techniques.Collaborated with staff to formulate budgets and improve department revenue.Actively listened to customers to fully understand requests and address concerns. Show less

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  PharmEvo Pvt Ltd

  Mar 2013 - Nov 2013

  Manager Clinical Research

  Enhanced clinical trials execution and training methodologiesManaged the entire life cycle of clinical trials, ensuring adherence to ethical and regulatory guidelinesProvided GCP training during trial initiation to ensure full compliance with all aspects of GCP throughout the studyStaffed trials with qualified personnelSpearheaded the establishment of audit procedures and provided site management support to ensure smooth monitoring of all trialsDeveloped recruitment strategies for all trialsEnhanced project coordination by implementing efficient systems to monitor all aspects of projects such as study details, investigator data, ethical review board information, patient recruitment activity, and financial managementMedical Writing: preparation of protocols, synopses, ICFs, CRFs, clinical trial agreements, and support with clinical report writingLine Management (CRAs and project assistants) and Training: monitoring, AE reporting, team communicationCRF writing, budget control, and site relationship buildingProvide training on ICH GCP, Research Methodology (protocol, synopsis, and dissertation writing), and epidemiological research methods at institutions and hospitals nationwideCollaborate with marketing and business development to train sales reps at new product launches and provide physician support.Represented organization at conventions, public hearings and forums, speaking for facility needs and sharing key activities. Show less

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  Metrics Research Pvt Ltd

  Dec 2013 - Mar 2015

  Director Clinical Research & Operations

  ResearchLeads the entire life cycle of clinical trials through targeted strategic visionEnhancing the effectiveness and scientific value of clinical trials through assisting local clients with design, study preparation, and initiation of trials while managing sitesStreamlined patient recruitment by establishing effective collaborations with trial sitesExpertise in medical writing applied to authoring of technical communications for CT reportsCo-authored and reviewed various components of clinical documentation, including clinical protocols, informed consent forms, and details of IRB submissions and communications.Developed, implemented, and revised SOPs for clinical trials and related activitiesOperationsCooperated with the CEO/Medical Director, Chairman, and B.O.D. to create and enhance communication, management, and operational strategies.Optimized clinical department operations to enhance productivity.Implemented strategies for enhancing efficiency in Clinical OperationsEnsured optimal quality of service through prompt and professional communication with clients, internal and external customers.Executed multiple quality improvement initiativesCoordinated Remote Audits and Quality Control Visits (CQC).Reported on Remote Audits and CQC visitsResponsible for CRA onboarding, management, and off-boardingLeveraged network to secure new clients and partnership opportunities.Managed daily operations by overseeing financials, Key Performance Indicators (KPIs) and employee performance.Cultivated strong industry relationships to promote services and improve business operations.Developed high-performing teams to consistently exceed goals, drive revenue and expand markets.Developed and maintained strategic partnerships with key industry players, enhancing business networking and collaboration. Show less

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  Bayer Pakistan

  Mar 2015 - Sept 2024

  Medical Operations Manager

  Managed and executed medical affairs and pharmacovigilance responsibilities.Focused on improving local operations through proactive identification of gaps, risk mitigation, and the creation of efficient systems to strengthen performance managementCollaborated with global, regional and cross-functional stakeholders to develop and implement effective medical strategiesEngaged in discussions on technical matters and scientific insights with Medical Advisors, MSLs, and Medical DirectorSignificantly enhanced the quality, productivity and efficiency of NIS/IIR execution through experience sharingProficient in the understanding and implementation of GCP guidelinesCountry Audit Lead for Medical, Commercial, PV, RA, and Quality departmentsHeaded continuous improvement as local audit lead, internal quality head and local innovation champion.Ensured compliance with corporate policies, directives, global and regional procedures, and health authority regulations as Local SOP and Functional Network ResponsibleConducted third-party quality checks for the Patient Support ProgramFacilitated audit compliance by extending support in vendor and distributor management.Collaborated with team members to achieve target results.Trained and mentored employees, vendors and distributors to maximize team performance.Identified issues, analyzed information and provided solutions to problems.Collaborated with staff to formulate budgets and improve department revenue.Met schedule using excellent planning and coordination skills.Explored and created new ways to resolve problems with processes, technology or team members to improve overall efficiency. Show less

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  Self-employed

  Sept 2024 - now

  Consultant | Clinical Trial Operations | Medical Affairs | Medical and Scientific Writing

  Highly motivated and results-oriented Consultant with 20+ years of experience in auditing, clinical development, operations, and medical and scientific writing. Proven ability to leverage strong organizational, leadership, and problem-solving skills to enhance GxP compliance, audit readiness, and ongoing improvement initiatives. Expertise in leading multinational clinical trials, providing strategic medical affairs advice, and overseeing complex research projects across various therapeutic areas.Consultant | Clinical Trial Operations – Head of Clinical Operations Successfully fulfilled a six-month contract for a local CRO working on projects for international sponsors.Key responsibilities: Strategic Planning, Clinical Trial Management, Cross-functional Team Collaboration, Project Management, Industry Engagement, Training & Development, Quality Assurance, Process Improvement and Optimization, Problem-Solving, and Motivation Show less