Gestionnaire Sénior, Opérations clinique (recherche clinique)

Clinical Study Manager (CSM)

GENERAL DESCRIPTION

The CSM is responsible for the planning and coordination of monitoring activities related to efficient performance of clinical protocols from study start-up to study closure with respect of applicable Standard Operating Procedures (SOPs) and GxP regulations.

. Report in a timely manner all major protocol deviations and/or non-compliance issues to the immediate supervisor;

. Participate to CRA identification and selection;

. Train and evaluate CRAs;

. Supervise CRA activities required to monitor the clinical protocols;

. Manage and decide monitoring priorities with CRAs;

. Ensure that monitoring activities are done in agreement with the approved monitoring plans;

. Review and approve CRAs’ monitoring reports when needed;

. Work closely with CRAs to assure appropriate action to rectify observed problems or non-compliance issues;

. Collaborate with other groups within the company such as Data Management, Medical Monitoring, Medical Writing and Finances

REQUIREMENTS

 Diploma: Bachelor’s Degree or equivalent experience in allied health field such as Nursing, Pharmacy, or Health Science or relevant health sciences educational background.

 Experience: Minimum of 5 years of management experience in Clinical research. Previous experience in clinical monitoring.

 Software: Suite MS Office.

 Languages: Good verbal and written communication skills (French and English).

 Skills, knowledge and aptitudes:

o Excellent communication and interpersonal skills;

o Leadership and coaching skills;

o Decision making skills;

o Customer service skills;

o Organizational, record retention and time management skills;

o Knowledge of FDA regulatory requirements and GCPs and GLPs.