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Clinical Project Manager EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED
As a key member of the Clinical Development team, you will be responsible for all aspects of the execution and conduct of one or more Phase 1-2 clinical studies. Successful candidate will be responsible for the management and coordination of clinical operational activities including the resolution of study and vendor issues to ensure that key study milestones are met. 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:
Independently oversees the day to day management of activities associated with assigned clinical trials from concept to completion of final study report; runs internal and external study team meetings
Assumes project management responsibilities for assigned clinical studies for project planning, budgeting and expense analysis; manages study budget
Maintains and ensures the quality and completeness of study master files across programs in compliance with GCP
Function as primary liaison with vendor and/or CRO regarding project activities and deliverables, including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities.
Participates in vendor selection process and management, and interact with vendors regarding invoices, preparation and management of work plans and issue resolution
Reviews and prepares various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure
Performs on-site monitoring as needed by GCP and reviews monitoring reports
Participates in Investigator selection, recruitment and training and provides final recommendations; Interacts with study sites during study conduct and evaluates performance; identifies opportunities for training
Requirements
BA/BS; Life Science degree a plus
Work experience to include a minimum of 4-6 years clinical trial experience with a solid understanding of functional area responsibilities associated with the clinical development process; monitoring experience a plus
Good working knowledge of GCP/ICH guidelines and regulatory requirements for clinical trial management.
Must have proven experience in all facets of clinical project management with strong 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.
| Location: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
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THIS JOB HAS EXPIRED
EnVivo Pharmaceuticals
Investors: BCM Technologies, Fidelity BiosciencesAll Jobs: at EnVivo Pharmaceuticals
| Web Site: | www.envivopharma.com |
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| Headquarters: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
| Industry: | Biotechnology |
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