Josee Bourque Email & Phone Number

Quebec, Canada

Quebec, Canada

• Responsible for data management activities required to ensure the generation of a study database in compliance with applicable regulatory requirements (CDISC) while respecting sponsor’s requirements and timelines;
• Participate in preparation/review of study documentation (e.g., data management plan);
• Lead Clinical Data Manager for a specific client on multiple clinical trials, for the last two years.
• Perform/review MedDRA coding for adverse events and medical history;
• Clinical Data Management System experience (e.g., Initiator and RAVE).

Quebec, Canada

• Maintain the concepts of data quality and the practices about review, coherence, and validation, as well as quality control management of clinical database;
• Ensure the integrity of clinical data and adherence to protocol, SOPs, and regulatory guidelines;
• Participate in preparation/review of data management documentation (e.g., data management plan);
• Clinical Data Management System experience (e.g., Initiator and RAVE);
• Review, analyze, and interpret safety clinical data from Phase I studies;
• Perform/review MedDRA coding for adverse events and medical history;

Quebec, Canada

• Review, analyze, and interpret safety and clinical data from Phase I-II studies;
• Ensure good quality clinical reports and associated documents within established timelines.

Quebec, Canada

• Review, summarize, and interpret clinical data in order to write clinical study reports while respecting timelines;
• Ensure data quality and integrity in clinical reports and all associated documents;
• Apply the appropriate regulatory requirements.

Developed and validated bioanalytical methods using chromatographic and immunochemistry techniques.

Responsible for the daily management of the GC/MS team (including application of GLP, protocol, bioanalytical method SOPs, and validation report writing).

Analytical and validation reports writing following review of validation data parameters.

Performed measurements of different bone markers and developed and validated RIA and immunoenzymatic methods.

Participated in clinical trials: coordinated and executed laboratory work and processed data. Supervision of graduate students. Responsible for daily management: radio-protection, inventory, and purchase. Method development using chromatographic and spectrophotometric techniques.