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Clinical Trial Operations Manager V Clinical Trial Operations Manager V
Ref No.: 17-14871
Location: Bridgewater, New Jersey
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 GCP's, 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).

Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned areas and liaise with external organizations on projects.
- Solid experience of CRO Oversight
- Strong interpersonal and communication skills (verbal and written)
- Ability to handle multiple task and to prioritize, strong organizational and presentation skills
- Leadership 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