Biovectra is seeking a Sr. Clinical Trials Manager to oversee the execution of clinical trials for in vitro diagnostics and medical devices. This fully remote position requires strong experience in clinical study management and adherence to regulatory requirements
Job Summary
The Clinical Trial Manager (CTM) will support successful and timely start-up and completion of clinical trials for in vitro diagnostics (IVDs) and medical devices (MDs) ensuring Good Clinical Practice (GCP) and adherence to all applicable regulations.
Primary responsibilities include managing the design and implementation of all clinical operational aspects of IVD clinical trials, serving as the main point of contact for stakeholders, and overseeing study-related work of Clinical Research Associates (CRAs).
The full-time equivalent pay range for this position is $127,680.00 - $213,465.00/yr plus eligibility for bonus, stock and benefits.
Matching Summary
Match Score: 85
Biovectra is seeking a Sr. Clinical Trials Manager to oversee the execution of clinical trials for in vitro diagnostics and medical devices. This fully remote position requires strong experience in clinical study management and adherence to regulatory requirements.
Salary
Base: $127,680.00 - $213,465.00/yr; Bonus/Equity: eligibility for bonus, stock; Benefits: eligibility for benefits
Skills & Requirements
Must-have
GCP and ICH guidelines adherence
Clinical study design and implementation
Investigator and site qualification
Trial Master File (TMF/eTMF) maintenance
Cross-functional team collaboration
Nice-to-have
Mentorship of junior team members
Process development and improvement
Diplomacy and respect for others
Key Requirements
5+ years clinical study management experience
Bachelor's degree or higher
Knowledge of GCP, ICH guidelines, and regulatory requirements
Experience in line management of CRAs and CTMs preferred