The Group Leader (GL) is responsible for managing and overseeing the projects and people in their Therapeutic Area, with respect to international study set up, execution and close-out and to clinical data collection and management. The GL for Rare Genetic Diseases and Neurodegenerative Diseases (RGD/ND) has management responsibility for staff located in Cambridge MA, Bridgewater NJ and Chilly Mazarin France Clinical Science & Operations (CSO) offices.
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In this role, the GL will report to the Head of Trial Operations and be a permanent member of the Trial Operations Steering Committee. The GL will also be a member of the local Cambridge CSO leadership team. The position will help to build a strong network with the Sanofi-Genzyme R&D unit.
The GL, RGD/ND will have responsibility for over 50 global staff. The GL manages a diverse portfolio of products and a significant number of ongoing small and large complex clinical trials, some conducted both in-house and fully outsourced to CRO’s.
Major Duties & Responsibilities
Leads deployment of operational excellence for the conduct of clinical programs (in/out sourced). Ensures expedited study start-up with integrated services, develops efficient contingency plans with anticipation to respect performance, quality, costs and timelines
Develops and implements optimized strategies and processes. Builds new approaches, processes and standards in ways of conducting clinical trials. Manages their team in developing a high level of team spirit and of motivation and delivery focus approach, maintains and develops operational excellence
Defines priorities and goals and follow ups on action items, assists in problem solving and corrective measures and conducts performance appraisals. Ensures training and development of expertise, promotes exchange of best practices and lessons learned.
Oversees the global staffing needs and consolidates resource budgets for their group, while taking into account the needs in other TO groups to allow flexibility in staffing management
Builds appropriate interfaces with other departments to develop the best trial management model and participates in cross-departmental working groups for process development/optimization. Ensures appropriate circulation of updated information and adequate reporting of implemented actions internally and externally
Collaborates with peers in CSI, Medical Operations, Biostats & Programming, Clinical Procurement, Quality, and Project Leaders to deliver the programs in the most efficient way to the highest quality.
Responsible for the successful and timely implementation and performance of the operational activities related to the clinical programs attributed to their group. Discusses and validates the operational strategy including allocated resources and timelines and provides input on budgets for clinical program implementation. Analyses and reports on productivity, quality and risk-assessment for projects.
Qualifications
Required Education/Experience
Bachelor’s degree and 15+ years of laboratory or medical experience (or equivalent), including 10 + years of clinical research experience in the pharmaceutical industry (or equivalent) is required.
Experience in direct and indirect people management in global setting
Experience in project and program management in clinical operations
At least 4 years of project management experience in clinical operations is required.
People effective management skills and leadership
Efficient communication and collaboration with project teams, departmental associates, internal and external partners, managers from various disciplines
Excellent organizational, interpersonal and communication skills (verbal and written); flexibility, diplomacy, efficient in matrix organisation
Project Management skills and ability to oversee several projects simultaneously
Ability to work effectively in a global environment
Self-motivation, attention to detail while overseeing and connecting with cooperating departments; results driven in terms of timelines and quality
Customer & quality focused
Experienced with clinical trial management and clinical data management systems and has an adequate level of understanding of database and programming concepts, database structures, file structures; good understanding of current trends in data management technology; thorough understanding of applicable regulations and inspection readiness
Competent in International Regulations / Guidelines / Good Practices pertaining to the pharmaceutical industry standards and practices for clinical / epidemiological trials conduct
Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions
Preferred Education
Advanced Degree
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