Location: Northern, NJ
Salary: With Experience
About the Opportunity:
A brand new opening has come available for a Clinical Trial Manager to join an established Pharmaceutical company based in Northern New Jersey. My client is a small to mid-sized company who offer their employees a positive working environment with a collaborative and tight knit team. They value their employees and want to further their growth by adding more talented Clinical Research professionals onto their team. You will be working on global clinical trials from study start up to close in the Pain therapy area. As a smaller company, you will have the ability to really own the study and work closely with the senior management team.
The Clinical Trial manager will be responsible for clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local requirements and company standard operating procedures. This includes writing and/or reviewing protocols, site selection, start up, study conduct, data cleaning, data review and study close-out for one or more clinical trials.
- Manage all of the clinical operations activities from study start up to close out.
- Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.
- Support study design. Review and/or writing of protocols, ICFs, CSRs, etc.
- Contribute to the development of Case Report Forms.
- Reviews regulatory packages for trial-related submissions to IRB/IECs.
- Plan timelines, conduct risk assessment/management and contingency planning. Ensure timelines are communicated to all functional areas (including vendors)
- Plan and/or conduct site evaluation, initiation routine monitoring visits. Develop and maintain effective relationships with clinical study sites.
- Plan and present at investigator meetings
- Act as primary contact for the CRO and other clinical vendors.
- Review monitoring visit reports; liaise with monitors to understand any trends on data management issues or other site issues to develop solutions
- Review clinical trial data. Monitor data quality and ensure appropriate quality measures are in place.
- Provide oversight and accountability of all third party vendors.
- Regular review of the Trial Master File (TMF) and ensure inspection readiness.
- BA/BS or higher in a scientific field. Five years of industry-sponsored clinical trial management experience required. Strong knowledge of clinical operations and the regulatory process – experience independently running/managing multiple clinical trials
- 5 years of Clinical Trial Management experience required
- Education: Bachelor’s degree required (scientific discipline preferred)