Sanofi Group Clinical Project Leader in CAN, Canada
Clinical Project Leader
About Sanofi – www.sanofi.ca
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi entities in Canada include the Diabetes and Cardiovascular Diseases Business Unit, the General Medicines, Established Products and Consumer Healthcare Business Unit, Sanofi Pasteur (vaccines), Sanofi Genzyme (rare diseases, multiple sclerosis and oncology) and Merial (animal health). Together they employ close to 1,700 people. In 2014 Sanofi companies invested $130.5 million in R&D in Canada, creating jobs, business and opportunity throughout the country.
Sanofi in Canada embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
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The Clinical Project Leader is responsible for the implementation and follow-up of clinical trials within the Clinical Research Unit (CRU). He/she must ensure that clinical trials are carried out within timelines and budgets and in accordance with Good Clinical Practices, ICH guidelines and Global and Local Standard Operating Procedures.
Key responsibilities and duties for this job
MANAGEMENT OF CLINICAL STUDIES (75%)
Participate in feasibility studies with the Medical Advisor.
Produce, implement, analyze and follow recruitment plans and key milestones for the studies for which he/she is responsible.
Periodically inform the members of the team in charge of the study (Global and/or local).
Facilitate research meetings with various departments in Medical Department.
Oversee research projects, ensuring completion on schedule and within budget.
Ensure that all clinical studies are conducted according to Good Clinical Practice, ICH, Standard Operating Procedures, local laws, and Policies and Procedures.
Anticipate project requirements and institute appropriate actions to ensure timelines and budget are met.
Organize study specific training for the project team and study staff as needed.
Accompany CRAs on pre-study, initiation, routine monitoring and close-out visits of study sites, when necessary.
Organize and participate in investigators or study meetings, as needed.
Establish, track and maintain study specific trial management tools/systems (IMPACT).
COMMUNICATION (10 %)
Keep in regular contact with Medical Advisors, in order to always be up to date on strategies and changes in the environment.
Negotiate and liaise in a professional manner with customers regarding all aspects of the project.
Collaborate with other Clinical Research Unit Managers to present unified messages to Clinical Research Unit personnel.
Ensure appropriate communication with Global Study Managers.
ADMINISTRATIVE MANAGEMENT (10%)
Negotiate contracts and sign contract agreement forms and grant agreements for studies for which he/she is responsible.
Produce study budget estimates and provide follow-up.
Provide Canadian and Global Management with monthly data on such matters as recruitment of subjects and other performance measures compared to the estimated plan.
Manage administrative files (budget, monitoring report).
Travel as necessary, consistent with project needs and management needs.
MANAGEMENT OF ONGOING IMPROVEMENT (5%)
- Take part in developing objectives and action plans for reviewing and improving work processes.
Key requirements for this job
- University Degree in Health Sciences or equivalent
- Minimum of 3 to 5 years of experience as a Clinical Research Associate
Specific skills and/or competencies
Management skills relating to projects, human resources and time.
Strategic thinking, negotiation as well as oral and written communication skills.
Leadership and team spirit.
- As necessary, consistent with project needs.
- English and French
Intermediate knowledge of Microsoft Outlook.
Intermediate knowledge of Microsoft Word.
Intermediate knowledge of Microsoft Excel.
Intermediate knowledge of Microsoft PowerPoint.
Beginner knowledge of required databases.
Job: Clinical Development
Primary Location: Canada-Remote CA-Remote CA
Job Posting: Nov 22, 2016, 4:49:01 PM
Job Type: Regular
Employee Status: Regular