Senior Clinical Project Leader at Sanofi

Job Purpose:

• The CPL is responsible for allocated clinical trials/studies within the cluster, ensuring compliance with sanofi quality standards and processes, regulations in force, the forecasted timelines, milestones and study budget.
• The CPL is the primary contact for the Regional Study Manager (RSM) or Global Study Manager (GSM) and represents countries within the allocated cluster.
• Leads the study monitoring teams in designated countries for applicable studies.
• Represents the CSU at Medical Affairs/Business Unit/ Project Review meetings to feedback on applicable studies.
• Assists the CPL Manager and CSU Head in the management of subcontracted studies, including liaison between global Clinical Science and Operations (CSO), Clinical Research Organisations, Regulatory Affairs and the Clinical Safety Lead.
• Is a key contributor to the effective functioning and connectivity of the Clinical Study Unit with key stakeholders.

Key Responsibilities & Accountabilities:

• Overall responsible and accountable for allocated clinical trials within the Clinical Study Unit.
• All study related activities at various stages of a clinical study – start up, recruitment, maintenance, close out and archiving.
• Study activities performed according to Good Clinical Practice, regulations in force and company standards and processes.
• Supports the management team in driving the Clinical Study Unit strategy
• Primary contact with identified key stakeholders - Ensures appropriate communication and support with these stakeholders.
• Selection of clinical trial sites.
• Submissions to Ethics Committees / IRBs
• Training of sponsor and clinical trial personnel on study related processes and requirements.
• Recruitment and retention strategy implementation and adherence.
• Creating and adhering to the Clinical Study Budget.
• Contract negotiation and agreement with Clinical Trial sites.
• Strong, positive relationships with applicable Clinical Trial sites.
• Maintaining clinical study documentation in an audit ready state.
• Compliance with requirements to all study related databases.
• High quality standards of study data collection and prompt data query resolution.
• Adequate provisioning of study materials and devices.
• Oversee monitoring activities through regular contacts with local monitoring team, local team meetings, review of monitoring visit reports and adherence to the monitoing plan.
• Preparation and prompt responses to audit/inspection reports and implementation of recommendations.
• Share lessons learned and ensure adequate deployment of identified action plans for improvement within the cluster.

Job-holder entry requirements:
Education:

• University degree in Health Sciences or equivalent
• Fluent in English

Experience & Knowledge:

• Knowledge of GCP/ICH phase I-IV clinical trials
• Clinical Research experience essential, minimum 5 years

Core Competencies:

• Project and people management skills
• Organizational, analytical and planning abilities
• Presentation skills
• Proactive and able to anticipate and resolve conflicts/issues
• Able to prioritize, time management
• Computer skills must include working knowledge of Excel, PowerPoint, Word and Outlook
• Literate in French will be an advantage

Behaviour

• Setting ambitious objectives
• Driving efficiency and results
• Acknowledging the right to experiment and make mistakes
• Stretch to go beyond – challenging the status quo
• Developing innovative solutions and ways of doing things
• Making decisions & driving necessary changes for performance
• Knowing how to deal with conflict
• Fostering and enhancing a positive team culture
• Acting in the interest of patients and customers
• Taking action instead of being told what to do
• Putting the interests of the organization before self