Project Management

Cynthia Gabriel, EXECUTIVE MBA, BSc, CCRP

**** *** ******* ***** ******* (QUÉBEC) H4R 2T2

Telephone: 514-***-**** email: ************@*******.***

WORK

EXPERIENCE

May 2014-

January 2011 – April 2014

MEDPACE, Cincinnati

Regulatory Submissions Coordinator & Principal Canadian representative

Principal Canadian representative of Medpace

Prepare, review, and file clinical trial applications to domestic and international regulatory agencies

Maintain Regulatory records, manage data management system (electronic data), including archive of submissions (paper and electronic)

Ensure submissions comply with applicable regulations and guidance documents.

Track submissions and CTA filings and ensure timely filing of documents

Review and observe local and worldwide regulatory guidelines to support regulatory submission activities

Supervise a team of six CRAs over global studies

Work with Clinical Trial managers (CTMs) and other members of the project team to ensure that all activities are conducted in compliance with international regulatory agencies regulations

Conduct meetings with internal teams, Sponsors, including meeting agendas, minutes, action items

Advise sponsors on changing regulations and compliance requirements

Review and approve labels for compliance with Health Canada requirements

Translate essential documents from English to French or vice versa

Merck Canada Inc

Senior Clinical Trial Coordinator

Coordinate multiple Phases Studies (I to III).

Director of the developing country timeline and assisting on deliverables.

Participate in clinical team meetings, in development activities and monitoring of objectives and action plan

Assist with start-up and close-out activities

Estimate country budget based on study parameters including local investigator meeting costs.

Generate and in charge of budget and clinical contract for the investigators and IRB services for each study.

Ensure monitoring of budgets and targets

Ensure compliance with regulatory agency and protocol requirements.

Assist in the preparation of ethics submissions

Send Study documents for initial package to sites with Central IRB or local ethics committee.

Updates and ensures accuracy of CTMS (at country level)

Perform Quality Control review of key documents as assigned

Work closely with and Serves as primary point of contact for CRAs, vendors and/or other functional team members.

Primary contact to site regarding routine study conduct and urgent issues.

Ensures TMF is kept current for trial.

Alerts Medical Monitor and any other appropriate team members, to serious adverse experiences, treatment failures, and other unexpected events that occur during a study.

October 2009 to January 2011

Merck Canada Inc., Montreal, Quebec

Clinical Trials Coordinator

The main contact for TMF (Trial Master File) in Montreal; collecting and filling (in an electronic system) study documents from study start to study close

Keep all essential documents in the SORF (Subsidiary Official Regulatory Files) until the end of the trial.

Send to archiving the study documents at the end of the trial.

Ensure completion of data entry of all study materials.

April 2007 to August 2009

ANAPHARM, Montreal, Quebec

Clinical Project Coordinator

Coordinate multiple Phases (I to III) innovator and generic clinical trial studies respecting ICH, GCP and GLP regulations from the nation agencies (FDA, EMEA and HPFB) and Standard operating procedures (SOPs)

Staff, volunteers, subjects and patients management

Responsible for effective communication within the project team and with functional management.

Provide regularly updates regarding the status and progress of the trials.

Act as the key client contact on assigned projects.

Coordinate and provide oversight of all elements of the project lifecycle from initial set-up to final invoicing.

Responsible for ensuring the trial is audit ready at all times (project team training records, central files, system validation, etc.).

In-house monitoring

July 2002 to

April 2007

February 2014-

EDUCATION

2014

2008

2007

2004

THERAPEUTIC AREA EXPERIENCE

CURRENT PROFESSIONAL AFFILIATIONS

ADDITIONAL RELEVANT TRAINING

ANAPHARM, Montreal, Quebec

Trainer/ Clinical Technician

Managed new trainees and evaluate their performance.

Director and mobilizer of the members in the trainees’ team.

Oriented new staff in their positions on study by ensuring that they know all the stages connected to the process of clinical research.

Documented all the information of the study in accordance with Standard Operated Procedures and GLP/GCP regulations

Performed procedures and record vital signs

Rigaud Benoit Foundation

Vice President

Work with the board of directors and other senior executives

Plan, develop and enforce policies and objectives for the Foundation

Manage employees and the day-to-day activities of the Foundation

Develop and maintain the financial budgets.

Participate in board and seniors executive meetings and meet established goals.

Concordia, Montreal, Quebec

EMBA

Laval University, Longueuil Campus, Longueuil, Quebec

Micro program in medication development

Hautes Études Commerciales (HEC), Montreal, Quebec

Certificate in Project Management

Université du Québec à Montréal (UQÀM), Montreal, Quebec

Bachelor in Biochemistry

Vaccines

Endocrinology (Diabetes, testosterone)

Oncology, Cardiovascular

Member of Society of Clinical Research Associates (SoCRA) since January 2009

Automated External Defibrillation (AED)

Cardio Pulmonary Resuscitation Certification (CPR)

COMPUTER SKILLS

Microsoft Office Suite: Excel, Word, PowerPoint, Outlook, Word Perfect, SAP, Comet, Adobe

LANGUAGES

French, English, Spanish

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