Clinical Study Manager
- Job posted by Cohen Veterans Bioscience
311 West 43rd Street
Clinical Study Manager
Cohen Veterans Bioscience (CVB) is looking for an experienced full-time Clinical Study Manager to work from our NY City office (311 W 43rd St) to assist with execution of CVB-sponsored clinical trial operations strategy under the direction of the Clinical Operations Specialist.
The Clinical Study Manager (CSM) role is primarily a tactical study delivery role. The CSM will help develop an integrated study start-up plan for CRO execution in a major national clinical trial and maintain oversight of the overall study implementation by in-house staff, CRO, and other vendors.
- Participate in site selection and site qualification with study team and CRO
- Oversee site start-up activities, acting as the Sponsor contact for sites, CRO, and other vendors
- Track site start-up progress, identify potential issues and proactively recommend mitigation plans
- Track training records and qualifications, as applicable, of all site study staff
- Assist with development of site budget templates and other study documents such as delegation of authority logs, screening and enrollment logs, recruitment tracking and enrollment progress, informed consent forms, and Study manuals
- Provide updates for quarterly progress reports
- Provide content for monthly site newsletters, draft agenda and run weekly study team calls with internal and external partners, provide meeting minutes
- Track IRB submissions and required reporting
- Contribute to the evaluation, selection, and management of CROs and other clinical trial vendors
- Ensure CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc.) ahead of study start
- Review monitoring trip reports and be main contact for monitors to address data and site issues
- Participate in CRF specification development and user testing
- Oversee study site close-out and support internal team in database close and lock for interim and final analyses
- Assist with collation of data packages for periodic DMC or other safety reviews
- Ensure consistency, quality and compliance with Good Clinical Practice
- Recommend and help establish clinical trial systems and processes, including documentation, QA, partnerships with CROs, investigator sites and physicians.
- Participate in the development and implementation of other key organizational process improvement initiatives
- BS required MS preferred
- 4-5 years relevant experience in study start-up leadership
- Psychiatry or Neurology experience is preferred with a BSc, 2-3 years with a MS/MPH/PharmD, or 2 years with PhD/MD
- Phase Ib/II/III Psychiatry or Neurology trial experience strongly preferred
- PMP, CCRA certifications desired but not required
- Experience working in both sponsor and CRO organizations is a plus
- Clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or CRO
- Monitoring experience
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator)
- Thorough understanding of pharmacovigilance, GCP, ICH, and FDA codes
- Highly organized and detail-oriented
- Strong communication and relationship management skills required
Cohen Veterans Bioscience is a national, nonpartisan research 501(c)(3) organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders.
We offer a highly competitive salary commensurate with experience and a full benefit package.
Please visit https://cohenveteransbioscience.applicantpro.com to apply. Please include resume, cover letter, and salary requirements. CVB is an Equal Opportunity Employer.
Minimum Education Required