Clinical Trial Operations Manager III
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Clinical Trial Operations Manager III
Ref No.: 17-00828
Location: Bridgewater, New Jersey
Start Date / End Date: 04/01/2017 to 09/30/2017
- Review and quality control of study documents for PAI
-Use developed tools to supervise and follow the PAI progress and quality
- Review monitoring visit reports and issue logs for selected sites, implement and follow corrective actions
- Check/compile needed documents in case of inspection (e.g.: training logs)
- QC of CSF and LSF when available
- Prepare PAI maps and prepare some answers to potential question in case of inspection
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: 6 to 9 years.

- Excellent organization skills
- Able to provide regular status updates
- Ability to lead PAI activities
- Knowledge and undertanding of updating multiple tracking tools (e.g. microsoft excel)
- Knowledge of Microsoft applications
- Clear communication
- Ability to interact and communicate with large teams effectively
-Global clinical trial experience
- Good follow-up