Clinical Trial Manager EnVivo Pharmaceuticals
As a key member of the Clinical Development team, you will provide project support to program team members by participating in the daily management of clinical trials. Successful candidate will be working closely with the Program Managers and will be responsible for completion of study start-up activities in the preparation and implementation of various clinical trials as well as ongoing maintenance through study completion.
This position provides an opportunity to join a growing Clinical Development department and contribute substantially to the successful implementation of CNS trials in the area of cognitive deficits, namely Alzheimer?s disease and Schizophrenia. In addition, there is an opportunity to expand your knowledge in the science of research as well as CNS through day-to-day activities and close interactions with the Research and Discovery groups within EnVivo.
Duties will include but are not limited to the following:
Review monitoring reports and interact with CRO to ensure the quality of monitoring and site management for clinical studies; Co-monitor clinical sites as needed.
Work with team to ensure query management and data retrieval is taking place in a timely manner.
Review site audit reports and work with team to resolve site issues (eg., staff retraining, additional resources)
Work with Program Managers to review and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure.
Maintain and ensure the quality and completeness of study master files across programs in compliance with GCP
Coordinate with the Program Managers and interface with the CRO as needed regarding follow-up of status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities)
Participate with the project team in weekly meeting with the CRO
Assist in planning and participate in conduct of investigator meetings
BA/BS; Life Science degree a plus
Work experience to include a minimum of 2 years clinical trial experience with a solid understanding of functional area responsibilities associated with the clinical development process.
Good working knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
Must have strong project management, communication (oral and written), and analytical skills.
Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required.
Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment.
Must be able to travel.
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Watertown, MA 02472