Under the supervision of the Centre for Innovative Medicine (CIM) and Clinical Research Core Service (CRCS) Associate Director, the incumbent is responsible for the supervision of the CIM Data Management and Biostatistics Department in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
In 2015, the CIM will move to the Glen Hospital and will become the largest clinical research Centre in Canada.
- Overseeing the start-up activities related to the creation of the new Department and the implementation of processes, procedures and establish standards based on good data management and biostatistical practices;
- Direct supervision and project allocation of data management and biostatistics staff;
- In collaboration with the QA staff, develop, implement and maintain the department’s policies, procedures and training;
- Develop and manage annual Departmental budgets
- Optimize operational costs with the objective of achieving full cost recovery
- Supervising/approving invoices and ensuring payment follow-up for the Department;
- Develop and build business relationships with clients;
- Generate Client quotes;
- Negotiate contracts while identifying and managing risks for the unit;
- Oversee the implementation and validation of EDC systems (RedCap and OS Clinical by Merge) ;
- Oversee the provision of Data Management and Biostatistical services for Industry and non-Industry funded studies;
- Conduct team meetings and ensure activities are harmonized within the MUHC sites (staff will be located on three MUHC sites);
- Ensure high quality project management
- Recognize recurring issues and analyze their causes in order to reach a solution
- Other duties as assigned by the supervisor.
-Bachelor’s degree in quantitative or scientific discipline;
-Minimum of 5 years of clinical data management and biostatistics experience;
-Experience in the pharmaceutical industry is preferred;
-Project, Contract and budget management knowledge;
-Ability to lead project teams and liaise with sponsors
-Experience working with electronic data management systems (RedCap and OS Clinical) and statistical analysis software.
-Excellent knowledge of international, federal and provincial laws and regulations governing clinical research (ICH E6-GCP, ICh E9 Statistical Principles etc.);
-Excellent knowledge of Industry standards (CDISC)
-Self-directed and organized. Able to work both independently and as part of a team;
-Excellent interpersonal skills;
-Excellent verbal and written communication skills in French and English
Status: Full time
Pay Scale: Commensurate with qualifications and experience
Work Shift: 8:30 a.m. to 4:30 p.m. (Mondays-Fridays)
Location: Montreal, Quebec