Clinical Trials Manager
EnVivo is developing its broad pipeline of diverse programs with a focus on leveraging novel mechanisms of action to treat CNS diseases like schizophrenia and Alzheimer’s disease in new ways and from multiple angles. Our approach is multi-target and multi-program by design - with no therapies currently available to treat the underlying causes and mechanisms of many CNS diseases, the scientific expertise and drug discovery ability to pursue a variety of disease targets is key. EnVivo has created a diverse pipeline of promising drug programs with mechanisms that could alter the progression of disease or provide sustained improvement in function to patients with serious CNS disorders, including Alzheimer’s disease, schizophrenia and others.
We are well financed and strongly positioned to develop and commercialize our own programs. Our primary goal is to rapidly and effectively translate our promising research and development programs into safe and effective CNS therapies for patients. As we also work to build an integrated drug company, our strategy is to retain a meaningful lead role in development and commercialization of our programs in certain indications and geographies, while also seeking to strategically partner our programs in order to fully realize the promise and potential of our pipeline.
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.
Please send resumes to one of the following:
Via fax: 617-225-4267
Via email: firstname.lastname@example.org
EnVivo Pharmaceuticals, Inc.
500 Arsenal Street
Watertown, MA 02472
EnVivo is proud to be an equal opportunity employer