A mid-sized, multi-national Biotechnology company headquartered in Massachusetts is looking to bring an experienced Clinical Trial Manager onto its team. This company focuses on unmet medical needs and combating Rare Diseases.
This company is working on a proprietary drug platform, with a pipeline boasting studies in Phases 1-4. To support their growth and abundance of studies, they are looking to add a talented, experienced Clinical Trial Manager to their team.
Responsibilities will include but are not limited to:
- Planning, executing, management, and oversight of Clinical Trials
- Leading vendor selection/site selection processes
- Oversees creation of study budget, monitoring, recruitment, and timeline plans
- Supervise, oversee, and maintain communication with CRO and other third-party vendors
- Lead the development of study protocols, study SOPs, ICF forms, CRFs, etc.
- Lead a cross-functional team including clinical operations, data management, regulatory affairs, pharmacovigilance, biostatistics, etc.
- Execute clinical studies according to ICH/GCP guidelines, FDA regulations, from startup through closeout
- Keep stakeholders informed of and up to date with study progress/advancement
- Bachelor's degree (life sciences preferred)
- Rare Disease Trial Management experience in an industry sponsor setting is REQUIRED
- 5+ years clinical research experience, must be in an industry sponsor setting, not only CRO or healthcare experience
- 3+ years Clinical Trial Management experience, in an industry setting
- An understanding of cross-functional clinical processes
- Ability to juggle multiple complex tasks at any given time