Clinical Trial Manager / Phase 1 (CNS) – Remote/US Based (Top $$)- Direct Hire
Our client, an NC-based Contract Research Organization that is undergoing tremendous growth, is actively recruiting for a highly skilled and knowledgeable candidate to assume the Clinical Trial Manager role on its Phase 1 CNS Team.
This is a home-based role (US) overseeing 2-5 CRAs in the delivery of site management clinical operations activities. We seek an experienced CTM who enjoys site management, driving monitoring teams and interacting with clients, site staff and investigators.
This CRO is building its Phase 1 CNS team and is seeking those with expertise in this therapeutic area – targeting those with Phase 1 experience.
Once travel opens up, it is expected to be 25% domestic to investigator meetings, team meetings, CRA training and site escalation activities. For now, most of these tasks are handled virtually.
Duties will include:
- Act as the Clinical Trial Manager for assigned studies, to include study specific management of 2-5 CRAs
- Primary point of contact from study start up through close out for CRA’s, inhouse support and clinical site teams
- Drafting / Finalizing the Clinical Monitoring Plan (CMP) and other clinical monitoring documents (monitoring visit report/letter templates, site/monitoring tools)
- Assist in designing and developing study-related documents (Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plan)
- Training and managing of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and Sponsor as needed
- CRA resourcing to meet demands for assigned studies / projects
- Involved in developing and implementing recruitment strategies
- Work with Project Management to assure the quality of the site data, addressing and identifying action plans as needed
- Responsible for regional monitoring strategy and accountable for forecasting and trending of site visits w/CRA team
- Reviewing/finalizing trip reports
The ideal candidates will offer a BS / BA or nursing degree and 8+ years of monitoring experience (2+ years as a Clinical Trial Manager or Lead CRA), including substantial Phase 1 experience and experience monitoring CNS trials. Further, we seek those with excellent organizational skills, strong communication skills and those who are interpersonally savvy. The success of this position requires the collaboration of many internal and external partners. We seek a natural leader, those who can create a sense of shared mission.
Longevity in work history will be important to this client, seek those who are looking for the long term.
Company will pay an excellent wage to attract and retain excellent people (to include a sign on bonus, unlimited PTO and great benefits). Many more details are available.