Our client is looking to fill the role of Clinical Manager. This job will be fully remote.
Responsibilities:
- Plan, execute, project manage and complete clinical trials according to applicable regulations and guidance; ICH, GCP and company SOPs
- Manager and oversee development of all pertinent clinical study documents including (protocols, informed consent forms, case report forms, study plans, study recruitment plans, monitoring plans, etc.)
- Assist with evaluating and selection CROs and other outside vendors (labs, IVRS, etc.), as well as investigative sites
- Collaborate closely with other internal departments to ensure timelines and study objectives are adhered to
- Assist with recruitment efforts to meet study enrollment timelines
- Will be involved with forecasting of study expenditures and resources to adhere to study budgets
- Maintain strong communication with CRO and investigative sites for study protocol compliance
Required Qualifications:
- 8+ years related clinical study oversight experience in a pharmaceutical environment
- 3+ years of successful clinical trial management within pharmaceuticals
- Bachelors Degree at a minimum (scientific degree) with a Master’s Degree preferred
- Prior CNS experience within Pediatrics is a huge +
- Global trial oversight is strongly preferred
- Prior clinical site monitoring experience is highly preferred
- Strong working knowledge of ICH, GCP, clinical trial management with exposure to Phase I-IV, start-up through closeout), scientific methods, research design, regulatory compliance, and clinical data management
- Prior protocol writing and development is highly desired
- Strong MS Office proficiency
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.