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Clinical Trial Operations Manager IV
Ref No.: 18-09273
Location: Bridgewater, New Jersey
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 I-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.
Experience with Investigator Sponsored Trials.
Bachelors level degree/RN (or equivalent).

Experience: 9 to 12 years

Excellent communication skills - strong vendor managment oversight experience - global studies experience
•Ability to lead the study team and being able to efficiently work with other CTOM's in the same study
•Ability to manage and lead international meetings (e.g. Study Teams)
•Ability to anticipate, timely escalate issues and to define appropriate action plans
•Ability to lead transversal projects
•Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot.)
•Ability to work cross-functionally fostering team spirit and team motivation (team work), e.g. study team or transversal project team
•Display stakeholder management skills (e.g. ability to manage expectations