Clinical Trial Operations Manager in Bridgewater, NJ

Provides input into identifying implications of study progress on overall timeline goals and conduct plans. Provides input into content and execution of investigator meetings and may present selected topics. With oversight, develops informed consent form and coordinates input. With oversight, provides point of contact for site questions relating to study conduct issues. Participates in the implementation of key organizational process improvement initiatives. Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases II-IV). Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation. Lead the multi-disciplinary team responsible for study completion. Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings. experience in Clinical Trials or Clinical Project management. 

Required:

experience in pharmaceutical industry or clinical-related discipline including years clinical research experience, including years of trial operations management.

Capable of interacting effectively with scientists and managers within and outside Trial Operations Department

- Leadership / Vendor Management skills

- Project Management skills

- 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 etc)

- 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

- Knowledge or ability to rapidly gain knowledge with programming/query languages

- Knowledge of industry data management standards and practices

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