Sanofi Group Manager SOP & Training in CAN, Canada
Manager SOP & Training
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.
Follow us on Twitter @SanofiCanada and on YouTube. Click here to learn why we’re one of Canada’s Top 100 Employers for 2016.
The Manager SOPs and Training collaborates with Local Canadian Affiliate members, North America CSU colleagues and Corporate Quality teams, and other subject matter experts to develop and implement local processes and training programs within the North America Clinical Study Unit (CSU) that encompasses policies, local and corporate procedures, guidelines and other relevant material essential to clinical trial activities in compliance with applicable country regulations (Canada and the Unites States), ICH-GCP (International Conference on Harmonization-Good Clinical Practices) Guidelines, corporate and local Standard Operating Procedures (SOPs).
He/she acts as the Clinical Quality Process and Training Ambassador (CQPTA) and participates, as required, in special projects/task forces/ committees that contribute to the overall quality of both the NACSU processes and NACSU clinical trial program(s).
The Manager SOPs and Training is responsible for identifying and anticipating NACSU training needs including defining, developing and promoting training plans and activities, and that current and new learning techniques and training styles are focused on the professional adult learning environment for the North America CSU (both Canada and the United States).
Key responsibilities and duties for this job
Identifies, in collaboration with key audience, coordinates and deploys the most appropriate programs and tools to meet training requirements, which must be consistent with Corporate R&D/ local SOPs and work practices.
In coordination with management team, assists in the development and participates in Quality control measures to ensure procedures are correctly interpreted and implemented, and to determine the quality of work performed by CSU personnel.
Ensures that local Quality Documents (QDs) recommended for complementing the R&D Corporate Clinical Development QDs are prepared, validated and distributed as appropriate.
Reviews audit/inspection reports in association with NACSU management and other appropriate staff in the NACSU to ensure that procedures are reviewed and updated, if required, to address audit/inspection findings – and to develop and implement corrective action plans as required.
Coordinates the personnel training records tracking program to ensure documentation of training as per NACSU SOPs.
Acts as Clinical Quality Process and Training Ambassador (CQPTA), responsible for evaluating impact of new corporate processes and or regulatory requirements on North America CSU developing plans of action and implementation strategies.
Canadian CSU point of contact for Study related Audits, Health Canada Inspections, Pre-Approval Inspection related activities and investigations of potential serious GCP noncompliance. Acts as support in this role to the US point of contact in the North America CSU
Consult as applicable with Clinical Trial Program team members for process, quality and or compliance related issues and ensure alignment to organizational expectations and or escalation as required to other stakeholders (senior management)
Identifies and uses training technologies and systems to support regionally based CRU Members and other potential stakeholders.
Key requirements for this job
- Bachelor Degree in Nursing, Adult Education or equivalent Health Care Professional.
- Minimum of 8-10 years’ experience in the Clinical Research Environment including both Pharmaceutical Research Experience and external (Hospital) experience
Specific skills and/or competencies
Minimum of 8 – 10 years’ experience in Clinical Research Previous experience as primary patient contact within Clinical Research environment such as: study coordinator and or Health Care Professional
In depth knowledge of both Canadian and US Federal Regulations as well as Good Clinical Practices (GCP
In-depth knowledge of Process and System development and implementation (Standard Operating Procedures and or Policies)
Excellent presentation/trainer skills with a demonstrated ability for coaching and mentoring
Excellent interpersonal and communication skills (verbal and written)
Keen interest in developing people
Ability to work in matrix teams in an open and professional manner
Strong organizational/prioritization skills for the management of multiple concurrent projects
Knowledge of e-learning and adult learning approaches for use with an in-house and remote team
- As required
- Good knowledge of spoken and written English
- Microsoft Word, Exel, PowerPoint, Outlook
Job: Pharmacovigilance & Epidemiology
Primary Location: Canada-Remote CA-Remote CA
Job Posting: Nov 25, 2016, 8:45:54 AM
Job Type: Regular
Employee Status: Regular