Project Manager Management

Sobia Hameed

**-******* ****** ****, ***# *** Ph: 647-***-****

Toronto, ON M4Y 1R7( willing to travel & relocate ) Email: abpsxh@r.postjobfree.com

Clinical Research

Design Analysis Management

CoreCompetencies: Research Design

Grants Writing, Publications

Data Management

Monitoring trials

Research Methodology

Critical appraisals

Research Implementation

MS Office, Access, Datafax EDC, EPR, MedDRA, Argus PROFESSIONAL EXPERIENCE

COBALT PHARMACEUTICALS Inc. (Watson Pharmaceutical Inc.) Mississauga, ON March 2012- Sept 2012

Drug Safety/Pharmacovigilance - Scientific Affairs: (contract position)

Primary Responsibilities:

Assists with classification of Adverse Drug Reactions (ADRs) and support the departmental Manager in the collection, accessing and reporting of Canadian and International adverse event information with Health Canada

Preparation of expedited reports, annual summary for cross licensed and local products and periodic adverse event reports (PSUR’s and ASR’s) and also maintains detailed log of all ADRs and filling reports for local archive compliance.

Entering case data into Pharmacovigilance database, and ensures information is current and accurate

Maintains a current awareness of local regulatory requirements and guidelines pertaining to Pharmacovigilance

Review and process adverse events (spontaneous, clinical, solicited etc.) reported by health care professionals and consumers covering all product categories in the portfolio and enter MHPD linelistings in Argus safety database system.

Responsible for the literature review and daily monitoring of reports (local and foreign cases) received from the Regional Centers (CIOMS) and approves/signs-off final reports for submissions to Health Canada (Expedited Reporting) according to regulations and guidelines.

Assist in reviewing and submitting product monographs and prescribing information for publication in the Compendium of Pharmaceuticals and Specialties and Compendium of Non-prescription products.

HAMILTON GENERAL HOSPITAL, Hamilton, ON 2010-2011

Research Assistant: (Multi-center Cardiovascular Trials - Brazil& Argentina)

Primary Responsibilities:Identify, help in the study site selection process, initiate, and eventually close out clinical study sites. To monitor the progress of clinical study sites (Brazil and Argentina) participating in a clinical study, and to assure the protocol is followed and data is reported accurately. Oversee the collection, entry, verification, management, tracking, and reporting of data and other documents related to study management, designing data collection forms(eCRFs), assist in developing and writing trial protocols and consent forms errors checking methods and related programs for efficient collection, analysis and reporting. Prepare, track, distribute and filing documents when they are returned, managing trial supplies, re-ordering drugs, maintaining the electronic Trial Master File (TMF) and also deal with suspected unexpected serious adverse reaction (SUSAR) notifications.Manages the administrative, clinical and ethical aspects of a number of clinical trials, at every stage of the process which include; Select international sites and investigators, creating and maintaining study contact lists for study team and international sites, setting up mail merges, archiving documents, sending study newsletters to sites, make sure correct essential documents are signed, completed and returned, organising and attending study team meetings and investigator meetings, assist with minute taking and documentation for sponsor or internal teleconferences. Sending protocol packages to sites, preparing on-site investigator & materials for site initiation visit, resupplying sites with study material, liaising with sites to chase essential documents, CRF pages, queries, CTP documents, providing site monitor & manager support. Create draft Data Management Plans (DMP) using a standard DMP template, prepare IVRS and IWRS scripts, eCRF’s with reference pages, codes for lookup tables and protocol deviation document and, draft edit check specifications, accurately and efficiently enter and validate electronically captured data, write clear queries on missing data and data points failing pre-defined range checks and/or logical checks, update Standard operating procedures (SOP’s) and personal training file on regular basis.Review and distribute study monitoring reports to internal and external study team members. To assist Project Manager/CRA in preparation and follow-up activities for pre-trial, initiation, monitoring, or close-out visits, maintain Visit Report tracking and trained data staff.

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TORONTO GENERAL HOSPITAL (UHN), Toronto, ON 2009- 2010

Clinical Research Coordinator: (hematology/Oncology Trials)

Primary Responsibilities:

Worked with MD and health care team include nursing staff and pharmacy in the recruitment of study participants (e.g. identifies and screens potential subjects, obtains informed consent, conducts pre-testing and administers questionnaires or other data collection tools). Responsible for all data collection and source documentation preparation,; identifies problems using assessment skills and reports any abnormalities to MD or health care team member by using RECIST Criteria.

Responsible for the daily obtainment and processing of adverse event data in accordance with Good Clinical Practice (GCP) guidelines, Standard operating procedures (SOP), TCPS and FDA regulatory guidelines

Coordinates patient visits schedule as per study protocol; executes all aspects of study visit (e.g. Health assessment, adverse events reporting, SAEs reporting, all communication with sponsors). Maintain all Investigational product Inventory and logs.

Review patient’s lab results and ECG reports, vital signs for any adverse event or change in health status. Entering data in electronic case report forms and responsible for all monitoring visits, Teleconference, staff meeting, record meeting minutes, presentations, literature search, assist in publication and manuscript and grant, consent and protocol writing. Responsible for initiation, close out and monitoring visit and also assist in study budget maintenance.

Responsible for all study correspondence with research contract organization and sponsors, REB and institutional REB. Provide all study medical chart review, shipment of study material, all related administrative work including faxing, filing, printing, mailing, data entry in electronic data captured(EDC), prepare all source document, eCRF and maintain study related logs, all ethics submissions and grant applications for REB, conducts telephone and/or clinical recruitment interviews to collect data and follow-up visits on phone. Regular health assessment of study participants by monitoring their records, lab values and adverse events by close monitoring of electronic patient record system (EPR).

CLINICAL RESEARCH ASSOCIATE (Trainee) ST. JOSEPH’S HOSPITAL/HAMILTON GENERAL HOSPITAL, Hamilton ON 2009 (Sept-Dec)

Research: Outcome Reduction with Initial Glargine Intervention (Reducing cardiovascular morbidity and mortality in high risk people with impaired fasting glucose, impaired glucose tolerance or early type 2 DM).

Research: Evaluation of the Effectiveness of Fax and Blackberry Based Symptom Diaries for Daily Monitoring of COPD Patients.

Cardiovascular and Respiratory Trial:

Primary Responsibilities:

Responsible for documentation (pharmaceutical, laboratory) review

Observation of education sessions

Assisted with informed consent forms, handling of trial supplies, filing, and the opening/closing of clinical trials

Assisted with patient screening, review of active protocol, and assessment

Baqai Medical University, Institute of Diabetology and Endocrinology, Pakistan 2007-2008

Diabetic Association of Pakistan and World Health Organization (WHO) Collaborating Centre

Research: Acute and Chronic Complications of T1DM (multicentre study)

Clinical Research Associate:

Primary Responsibilities:

Responsible for the management and monitoring of clinical studies

Maintained forms with incorporated parameters required for the standard of medical care of diabetics, and used for recording information at the time of patient’s initial outpatient visits to the Baqai Institute of Diabetology and Endocrinology

Responsible for analysis of patient anthropometric and biochemical characteristics

Assisted in the management of site communications regarding recruitment, protocol, eligibility, as well as answering medical questions and all administrative duties including staff training, filling and data entry.

Assisted in the development/review of study related documents such as informed consent, protocol amendments, source documents, data management guidelines, study manuals and instruction materials, as well as trip monitoring reports

Responsible for the daily obtainment and processing of adverse event data in accordance with Good Clinical Practice (GCP) guidelines, Standard operating procedures (SOP), TCPS and FDA regulatory guidelines

Responsible for coordinating and managing patient care, as well as the administration of informed consent documents

Solely responsible for scheduling appointments, laboratory and radiographic evaluations, interpreting test results, tracking patients on a daily basis for response, and recording biochemical parameter

Liaquat National Hospital, Pakistan 2005-2006

Research: Aspirin Usage in cases of Acute Myocardial Infarction(Surgery) Multicentre International Studies

Clinical Research Associate:

Primary Responsibilities:

Participated in all research related meetings and conference calls

Responsible for recruiting patients, data collection and travelling to study sites to supervise and coordinate clinical studies

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Solely responsible for preparing Informed consent, case report forms, verifying source documentation, and ensuring compliance with Good Clinical Practices

Conducted all aspects of site monitoring as well as study monitoring, including field initiations: Includes pre-study selection, quantitative interviews, site initiation, close-out visits, maintaining study files, monitoring and collecting adverse experiences, as well as follow up letters

Monitored and recorded risk factors, family history, dietary history, time to reach ER after the onset of symptoms, management of ACS in CCU, as well as the outcome of the treatment

Liaquat National Hospital, Pakistan 2004-2005

Clinical Intern: Cardiothoracic Surgery Department

Primary Responsibilities:

Worked under the supervision of Cardiac surgeon in the Cardio-Thoracic Surgery Department

Responsible for assisting with cardiac surgeries, biopsies and angiographies including all cardiothoracic

procedures, post surgery follow-ups, and routine physical examinations

Responsible for assisting with clinical research activities, and administrative activities as required

PROFESSIONAL PROJECTS AND PROFICIENCIES

Responsible for the coordination, planning and implementation of research project on the Awareness of Breast Cancer among Female, College Demographic. As winner of the Year 1 Project during Medical Education, the project was identified, publicized, and acknowledged.

Assisted hospitals, clinics, care centres, as well as Human service agencies (affiliated with medical university) with data management plans, as well as the implementation of data collection protocols.

Actively participated and organized the World Diabetic Conference with the Baqai Hospital, in collaboration

with the World Health Organization (WHO).

Participated in the anti-polio campaign program held by the Baqai Community Health Centre under supervision of the World Health Organization

FORMAL EDUCATION

McMaster University, Hamilton, ON

Certified Clinical Research Associate Program(Post Grad Certif) 2009 – 2010

Working skills center, Toronto

Administrative (advance Microsoft office) diploma 2009 - 2009

Baqai Medical University, Pakistan

MBBS (Bachelor in Medicine, and Surgery) - Honours 2000 – 2004

SKILLS

Proficient in a variety of software applications including: Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Access, Adobe Framemaker), datafax, EDC(Wireframe), EPR and included all administrative duties with accurate keyboarding 50wpm.

Strong interpersonal skills, Detail oriented, problem solving and multi task capabilities, able to work in fast-paced environment, hardworking, fast learner, critical thinking, energetic, able to work independently or in team and willing to travel and work over-time as required.

Completed course for IATA shipping regulation certificate, working towards SOCRA by completing one year clinical research education in McMaster University, complete all courses from McMaster University about Grant writing, Critical appraisals, Publications and all research related duties.

CERTIFICATE & TRAINING

IATA shipping regulation certificate.

Vital signs Clinical Skills Training Certificate.

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Presenting Informed Consent Form Process Training session.

GCP/ICH Certificate.

IHI Certificate of Completion Basic level for Patient safety, Quality Improvement and Leadership in Healthcare Improvement.

PORTFOLIO & REFERENCES ~ AVAILABLE UPON REQUEST

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