Sanofi Group Sr Clinical Trial Operations Manager in Bridgewater, New Jersey
Sr Clinical Trial Operations Manager
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health. Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.
Our extensive research and development efforts encompass a wide range of therapeutic areas that are in line with public health issues, trends and the most pressing health needs.
Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.
Commitment is our Strength. Ready to grow together.
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Sanofi US is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi US is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees.
Job Title: Senior Clinical Trial Operations Manager
The Senior CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets. The senior CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with others CSO department representatives (e.g. Medical Operations)
Provide oversight of a study to ensure progress according to study timeline - Lead the clinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study.
Bachelor's degree (advanced degree preferred) plus at least 10 years of experience in pharmaceutical industry or clinical-related discipline including at least 8 years clinical research experience. 2 years of prior management and/or supervisory experience in coordinating international clinical trials is required.
Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects.
Strong interpersonal and communication skills (verbal and written) - Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills
Strong Project Management and planning skills
Excellent decision-making and problem-solving skills
Ability to work autonomously and to efficiently & effectively provide status reports
Ability to anticipate and timely escalate issues and to define appropriate action plans
Good cross-functional team leader who fosters team spirit and team motivation (team work)
Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.)
Ability to work in an international environment with internal and/or external partners (CROs)
Strong English skills (verbal and written if English is the second language)
Ability to adapt and be flexible to change and managing internal and external impediments
Understanding of data base concepts preferred
Knowledge or ability to rapidly gain knowledge with programming/query languages
Knowledge of industry Data Management standards and practices
Job: Clinical Development
Primary Location: United States-New Jersey-Bridgewater
Job Posting: Sep 26, 2016, 8:22:14 AM
Job Type: Regular
Employee Status: Regular