Project manager/ Medical advisor
Resume:
Dr. Muhammad Ibrar Mustafa
(**** Apt # **, Querbes, H3N 2B2,
Montreal, Quebec, Canada.)
**.************@*******.***
***********@*******.***
OBJECTIVE
To obtain a position that will enable me to use my strong organizational skills, educational background, and ability to work well with people and to add value to performance with quality assurance.
PROFESSIONAL PROFILE
5 years plus experience in Clinical Research & Medical trainings
2 Years of Clinical Experience and Lectures to Medical students
Command on all therapeutic areas and deep knowledge of human Diseases
Knowledge of Market demands and trends.
ICH-GCP and FDA regulations trained and Knowledge of regulatory and business requirements
Execute projects from feasibility to completion/Identify Risks and developing contingency plans
Experience in site selection, setup, feasibility, monitoring, management, and patient safety reporting
Can easily manage Working under pressure and in group with multitasking skills
Innovative Problem solver, and self-starter, Strategic thinking, Excellent analytical, organization and planning skills.
Proficient in English Language
Good presentation skills
Proven quality to lead and manage teams.
PROFESSIONAL HISTORY (Research)
GlaxoSmithKline,(Medical Affairs) Lahore, Pakistan 1/ 2009- 12/2011
Medical Advisor, Clinical Project Manager & Lead Medical Trainer R&D (CME), 3/2010- 12/2011
Sr. CRA (Clinical Team Leader) 1/2009-3/2010
Job Description as Project Manager (Oncology, Metabolic, Hematology-GIT)
a. To manage and train research teams i.e. CRAs as well as Site Staff on protocol
b. To make and update budgets for the Clinical trials
c. To manage Study metrics & periodic study-update meetings with teams and senior management
d. To execute projects from feasibility, site/investigator selection to study-closeouts
e. To identify risk and develop contingency plans
f. To conduct audits and keep data audit ready.
g. Review eMVRs and safety reports
Oncology Phase III global multicenter IND clinical trial, 5 sites, 245 subjects
Hematology (ITP) Phase II, global, multicenter, IND Clinical trial, 2 sites, 25 subjects
Metabolic (Bone mineral density in Diabetes) Phase III, global multicenter, IND clinical trial, 2 sites, 44 subjects
Metabolic (Bone mineral density in Diabetes) Phase III, global, multicenter, IND clinical trial 2 sites, 30 subjects
Cardiology Phase III, global, multicenter, IND clinical trial 6 sites, 240 subjects
Job Description as Medical advisor/Continued Medical Education Lead Trainer (2010- 2012)
a. To train the clinical research operation team on protocols related to clinical research projects to update understanding of the team members of therapeutic areas and latest advancements.
b. To present and conduct meetings with KOLs and patient focused campaign on different therapeutic areas and latest scientific advancements
c. To make strong ties with KOLs and update them on companies latest products and pipeline products
d. To present latest medical information in scientific symposia and investigator meetings
e. To create, review, update, circulate and evaluate safety reports.(pharmacovigilance)
Proven ability as an expert trainer and secured the appreciation and award of The Best Trainer GSK- Pakistan.
Job Description as Senior CRA / CRA
a. To conduct monitoring visits, investigator meetings, audit meetings
b. To mentor junior CRAs and delegation of tasks
c. To make electronic monitoring visit reports
d. To submit data within timelines
Hepatology-GIT Phase III, global, multicenter, IND clinical trials (Team Lead)
3 sites, 40 subjects (Hepatitis C)
3 sites, 26 subjects (Hepatitis B)
2 sites, 5 subjects (an extension study of both the above trials Hep. B&C)
Boston Scientific 1/2007 – 12/2008
Clinical Research Associate
Cardiology Phase IV: 2 sites, 50 subjects (Only close out activity)
Ferozsons Labs Ltd. (Medical Affairs) 2007-2008
Clinical Research Associate & Medical Science Liaison
Oncology Phase IV Site selection, initiation, site trainings
Training of Sales teams and KOLs on new scientific advancements and general knowledge on latest trends in treatment modalities as well as update on related Clinical research data
Hameed Latif Hospital - Clinical Research Coordinator (- Oncology) 2/2006 – 12/2006
Jinnah Hospital - Clinical Research Coordinator (- Cardiology) 2/2006 – 3/2006
PROFESSIONAL HISTORY (Clinical)
Masood Hospital Lahore, Pakistan 9/2006 – 12/2006
Medical Officer (General Surgery)
Jinnah Hospital, Lahore 2/2005- 8/2006
Resident Physician, Department of Cardiology 2/2006 – 8/2006
Resident Surgeon, Plastic Surgery 8/2005 – 2/2006
Clinical Observer ship, Department of Medicine 2/2005 – 8/2005
PROFESSIONAL ACHIEVEMENTS
Clinical Trial Management
Proactive management of studies (phase II, III, IV) with transparency having recruitment target ranging from 24 subjects to 245 subjects per trial.(Hepatology, Cardiology, Oncology, Metabolic)
Successfully established New Clinical Sites and always completed target recruitment in time.
Always expedited the project within time lines to add value to work
Member of Monitoring/data Quality assurance team R&D (GSK-Pakistan)
Working as Country Medical Monitor/Advisor for a Cardiovascular studies.(Successfully presented scientific data and literature in Investigator meetings as well as in liaison with sales teams during trainings.)
Collection, evaluation, Interpretation, formation and in time submission of safety reports with central team and regulatory department.
Attending and presenting scientific information and data during Country medical department (CMD) meetings as well as Investigator meetings.
CMD and Site Trainings
Trained monitors/physicians as well as site staff on GSK study processes and ICH-GCP
PACE (Inform) system Expert,
eTrack system expert,
Lead Trainer of Continued Medical Education (CME) GSK Pakistan and improved the training graph with clear margins.
Member of Risk Management team as Drug Safety physician.
Best Local-trainer R&D-GSK, 2011.
Data Quality and Compliance
100 % Pharmacogenetics Compliance for all my studies.
Improved data quality within time lines and zero queries at data submission.
Local Processes: Reviewed and Improved local processes and local CMD SOPs at a National Company as well as multinational company and a contract research organization (CRO).
Reviewed and helped in Designing Protocols and Case Report Forms for Local Studies at a National Company and a contract research organization.
Drug safety experience
Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations
Extensive knowledge of drug safety and drug development process and procedures
Knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines
Job Description as Research Associate Pharmacovigilance
a. Handle responsibilities of reviewing and processing adverse events reported by investigators
b. Handle responsibilities of developing concise, accurate and well-written case narratives
c. Perform the tasks of maintaining the safety database and perform coding of diseases as well as adverse events according to the project-specific coding conventions
d. Responsible for making presentation of safety process at clients and investigator meetings
e. Handle the tasks of checking the accuracy and cohesiveness of adverse event and serious adverse event
f. Responsible for preparing and reviewing safety reports
g. Perform the tasks of checking patient eligibility for clinical trials
h. Handle responsibilities of entering safety data into the database and reporting systems
i. Perform the comprehensive reviews of serious-adverse events
j. Responsible for drafting case narratives and processing case-related information
ADDITIONAL RESEARCH TRAINING
Basic & Advance Monitoring Courses by BE&T GSK (Singapore)
Communication skills and professional writing workshop.(Singapore)
ICH-GCP training by Kriger-International Ontario Canada.
Clinical Trial Monitoring certification CCRP by Kriger-International Ontario Canada.
Attended Investigator’s Meetings for different Clinical trials
ICH-GCP Training Workshop attended at Bahria University Karachi organized by combined efforts of Higher Education Commission Government of Pakistan, National Core Group and Metrics Research and Bahria University.
Global Community of Practice meeting in Frankfurt, Germany.
Medical Monitor for Clinical Trials Training at GSK Pakistan.
Clinical project management training at GSK.
Several Seminars and workshop on leadership.
Received trainings on GSK systems and served as local expert.
AFFILIATIONS/MEMBERSHIPS
Pakistan Medical & Dental Council (Permanent Member)
Institute of Clinical Research- UK (Professional Member- MICR) rewarded after 5 years experience in clinical research.
Association of Clinical Research Professionals (ACRP), North America(applied)
HONORS AND AWARDS
Won PACE quiz in 2010 (GSK PK)
No Major/ Critical Audit Finding(Clear Audit-2009)
“Best Scorer” in monitoring @ GSK Part I Course held at Singapore.
Best Team leader/ Senior Monitor at GSK 2010.
Was awarded Appreciation Certificate by Global head (Pam French) and Director APJEM (Patricia Davies) on Clinical trial management.
Was awarded appreciation certificates by Senior Director GSK North America (Dr. Antonio Nino) on scientific approach and problem solving skills with clean Audit enabling the team to achieve target of data submission timelines.
Was appreciated by Principal/ Dean/ Professor of medicine/ Key principal investigator of Services Institute of Health Sciences for support as a medical monitor/MSL in metabolic clinical trials especially on Diabetes.
Served as Medical Advisor/ Medical monitor at Rx-Research CRO in Pakistan.
“Best Demonstrator of the year 2006”Award (Department of Cardiology-JHL)
Captained College soccer Team and gymnastics Team at Allama Iqbal Medical College Lahore.
Awarded for services (as general secretary) for Patients Welfare Society-AIMC_JHL.
Won competitions in Gymnastics.
Winner of Staff`s Gold medal in Matriculation Board result ( Secondary school certificate)
Merit Scholarship Holder; Nov 1993 for BEST ALL ROUNDER STUDENT (Multan Educational Board, Government of Pakistan)
“Winner of Divisional Science Quiz” Organized by Divisional Educational Board, Multan (1997)
EDUCATION
MBBS(Equivalent to MD), Allama Iqbal Medical College, Lahore, Pakistan, 2005
FSc.(Pre-Med) Cadet College HasanAbdal, Attock, Pakistan, 1999
Secondary School Certificate (Matric), Khanewal Public School, 1997
TECHNICAL SKILLS
eTrack, RAMOS (IVRS), PACE (GSK-Quiz Winner), Insight, Xpress, eMVR writing, M.S Office (Word, Excel, Power point), Lotus Notes, Outlook
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