Clinical Study Manager – FSP
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Accountable for achieving clean data as specified in the study protocol
- Manages all clinical operational and quality aspects of allocated studies
- Develops clinical tools in conjunction with the Data Quality Plan
- Ensures timely set up, organization, content, and quality of Trial Master File
- Collaborates with project manager for client meetings and presentations
- Regularly communicates with team and leads team meetings
- Responsible for training in standardized clinical monitoring processes
- Communicates with study sites regarding protocol and participation issues
Requirements
- Bachelor's degree or equivalent
- 8+ years of relevant experience
- Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916
- Strong planning and organizational skills
- Strong interpersonal and problem-solving skills
- Solid understanding of change management principles
- Comprehensive understanding of clinical monitoring practices
- Strong judgment, decision-making, and risk management skills
- Effective oral and written communication skills, including English proficiency
- Strong financial acumen
Benefits
- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical monitoring practicesdata quality planTrial Master File managementchange management principlesrisk management
Soft skills
planning skillsorganizational skillsinterpersonal skillsproblem-solving skillsjudgmentdecision-makingeffective communicationfinancial acumen
Certifications
Bachelor's degreeIVDRISO20916