Senior Clinical Trial Manager - Remote
As the Sr. Clinical Trial Manager, you’ll have the opportunity to:
- Plan and execute clinical trial programs for assigned area of focus for registrational trials and non-registrational and research studies for both US and outside US.
- Provide technical expertise to staff for the development of clinical trial documents and records (protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct.
- Oversee complex and significant studies.
- Represent the department at cross functional project teams and Business Unit level.
- Implement global study support strategies and initiatives.
- Regularly interact with executive management on work of area(s) that impacts larger organizational goals.
- Serve as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
You'll need this to be considered:
- Bachelor's degree in scientific discipline or related field or equivalent along with 7+ years' experience in clinical trials in biotechnology, pharmaceutical, or CRO, including responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
- Must have experience with inspection readiness and NDA submissions
- Strong knowledge of ICH-GCP guidelines and other regulatory requirements clinical of trial management