Prometic BioSciences Inc. develops unique innovative therapeutics, orally active compounds that target multiple uncovered medical needs in the fields of hematology, oncology, nephrology, fibrosis and autoimmune diseases.
The department of Clinical Affairs of Prometic BioSciences is seeking a Manager, Clinical Data Management, to work with its team in Laval, Quebec. Reporting to the Director, Clinical Affairs, the incumbent will lead the data management activities at Prometic. They will be responsible for overseeing and supporting Prometic clinical trials and ensuring that data management objectives are met in accordance with clinical timelines and requirements. The incumbent will be responsible for the complete data management process, from study set-up to closeout, for individual protocols throughout the course of the study, and act as the primary contact on all data management study-specific issues. They will organize the cleaning efforts with the internal or external study team and participate in data cleaning. They will act as an internal consultant for clinical data management tools, standards and practices.
The Manager, Clinical Data Management, responsibilities will include:
The selected candidate will hold a BSc in the Health Sciences or Quantitative fields, with seven (7) years of experience in clinical data management, in the pharmaceutical/biotechnology industry, including two (2) years of vendor management experience. A comprehensive understanding of GCP/ICH standards, FDA regulations, as applicable to data management, is also sought, as well as knowledge of CDM systems, Working Practices and relevant Clinical Operations SOPs, Clinical Data Interchange Standards Consortium/Study Data Tabulation Model (CDISC/SDTM) and clinical data coding principles. The incumbent should possess data review hands-on experience with database design and concepts, and experience in conducting trials using Electronic Data Capture (EDC), IVRS, and ePRO. Experience training and presenting at Investigator Meetings is required as well, together with familiarity with MedDRA and WHO-Drug dictionaries. Knowledge of SAS or other relevant programming skills are strongly recommended.
The following criteria are required as well:
Prometic offers a competitive compensation, comprehensive benefits program, a flexible work schedule and a casual working environment.
To apply, please send a cover letter and copy of your resume to **@********.com with the following reference: PBI-Med-1701. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview. For more information about Prometic, visit our website www.Prometic.com.