Experience

Montreal Health Innovations Coordinating Center (MHICC)

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• SENIOR CLINICAL DATA MANAGER

  • Apr 2017 - Present

  • Provide mentoring/training to Data Coordinators• Participate in project team meetings and recommends processes that lead to timely and successful completion of administrative tasks• Interact with sponsor in designing CRF and related data entry applications to mirror the protocol• Discusses requirements, timetables and deliverables with the sponsor• Provides guidance to the sponsor in terms of Data Management aspects of clinical trials• Write data management plan• Assists the Clinical Programmers in the database development• Implements data entry conventions• Defines, tests and validates edit checks required• Ensures the integrity of clinical databases by performing the following activities: - Document and resolve data problems - Perform review of edit output - Write and resolve data clarification forms - Perform regular scheduled quality control procedures (including reviewing listings) and review of critical variables - Perform coding activities for Medications and Adverse Events• More specifically, in an Electronic Data Capture (EDC) environment: - Coordinates the user acceptance testing (UAT) of the operational database and data checking procedures - Performs and/or assists the EDC training sessions for a given trial - Monitors the receipt of data to ensure that quality data is available for project milestones (decisions analyses, database locks) - Reviews and resolves data discrepancies generated by the system and issue manual queries as appropriate - Generates listings for team review• Communicates in a timely and effective manner, with the appropriate internal and external individuals involved in the project• Assists in the development, revision and/or implementation of Standard Operating Procedures (SOPs) for the Data Management department• Participates in sponsor meetings as required

• CLINICAL DATA MANAGER

  • Jan 2009 - Apr 2017

  • Write Data Management Plan• Test and validate edit checks• Ensure the integrity of clinical databases by performing the following activities: - Document and resolve data problems - Perform review of edit output - Write and resolve Data Clarification forms - Perform regular scheduled QC procedures (including review listing) - Perform quality control review of critical variables - Perform Coding activities for Medications and Adverse Events - Assist the Manager, DMS in the quality and critical variables review - Assist Manager, DMS in project documentation



Montreal Health Innovations Coordinating Center (MHICC)

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• CLINICAL PROJECT MANAGER

  • 2006 - 2008

  • Identify and recruit potential investigators; • Ensure receipt of all regulatory documents for Trial Master File filing (REBA, NOL, ICF, Licence, CV, etc.); • Collaborate in the review and development of study plan (monitoring plan, Data validation guideline, etc); • Review/approve study-related documents including monitoring reports, Case Report Forms, Informed Consent Form; • Ensure professional communication with clients, partners and subcontractors to ensure proper information distribution among all parties; • Provide study guideline specifications to Clinical Research Associates, as required; • Implement new strategies to respect clinical trial’s objectives and timelines; • Ensuring frequent transmissions of all study recruitment reports to Sponsor; • Organize meeting in collaboration with sponsor and Investigators • Ensure the project is completed within budget, schedule and according to contract specifications; • Ensure project progress according to quality standards, SOPs, ICH-GCP guidelines;



CIRION BioPharma Research

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• PROJECT COORDINATOR

  • Jul 2005 - Jul 2006

  • Involved in the development of Sample collection Instructions in Laboratory Manual with Project Managers; • Participate in the implementation of strategies to improve blood samples receipt and analysis; • Perform quality control verification of data provided by the clinical sites (requisition forms); • Provide study-specific instructions to site Coordinators for sample processing and shipment; • Coordinate specimen transportation from sites to the central laboratory facilities; • Issue Data Query Forms to participating sites for inconsistencies pertaining patient data and follow- up until resolution; • Ensure that samples are drawn and analyzed according to study protocol schemes; • Ensure transmission of Laboratory analysis reports to Sponsor; • Coordinate sample kit replacement to participating sites;



Anapharm (InVentiv Health Clinical)

• Montréal, Québec, Canada

• CLINICAL PROJECT COORDINATOR

  • May 2004 - Jun 2005

  • Responsible for the coordination and management of bio-equivalence studies in accordance with protocol requirements and quality standards, SOPs, ICH-GCP; • Supervise clinical staff during main study days on study specific duties to ensure accuracy of the data entry; • Responsible for data entry verification (Qc) and for ensuring that corrections are made in a timely fashion by clinical staff as per internal SOP; • Responsible for issuing SOP and Protocol deviation and determine impact on study results with scientific department ; • Review staff schedule before subject confinement to ensure that all study activities are covered; • Responsible for the coordination of personnel training session when special tasks are required by the study protocol; • Ensure receipt of regulatory documents (NOL, Financial discloser, etc) before dosing day; • Review screening laboratory results to ensure compliance according to exclusion/inclusion criteria before dosing day; • Issue subjects attendance and AE/SAE report to Project Manager after each confinement period; • During confinement period, ensure proper follow-up of ongoing Adverse Event(s) by clinical staff; • Follow-up with Principal Investigators to determine clinical significance for out of range laboratory results (or AE) and schedule subjects for control when applicable; • Responsible for subject compensation at each study period and at the end of study;



Anapharm (Inventiv Health Clinical)

• CLINICAL TECHNICIAN

  • 2002 - 2004

  • Responsible for providing subjects all information pertaining to study protocol/procedures and obtain written inform consent. • Perform and train staff on specific screening duties in accordance with protocol requirements, SOPs, ICH-GCP. • Responsible for plasma and serum sample processing collected during screening; • Responsible for issuing screening SOP deviation • Responsible for monitoring vital signs (BP, Resp. rate, oral temp.), performing ECG's, measurement of weight, height (for BMI) and informing patient in case of non-compliance with study requirements.