Registry Manager
Thermo Fisher
Summary
As a Registry Manager, you will serve as a key member of the team and will be responsible for the day-to-day operations at assigned participating sites.
Job description
A Day in the Life
- Works on site problems of moderate scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
- Interface with sites participating in assigned registry.
- Communicate appropriately to registry management all site concerns or issues that may arise.
- Implement and facilitate protocol execution and regulatory compliance during site initiation and throughout sites participation in the registry.
- Identify and support site staff with data queries in a timely manner.
- Conduct SIV and Remote Site Management and Metric Review visits.
- Maintain registry Master File documentation and performance.
- Identify and communicate poor performing sites in a timely yet appropriate manner.
- Provide input to the development of registry timelines, procedures, forms, registry support materials, manuals, and tracking systems as requested by manager.
Keys to Success
Education
- Bachelor's degree, preferably in life sciences, public health, health services research or related area and or equivalent experience
- Advanced degree, Research, and regulatory certifications, i.e., RAPS or ACRP certificates preferred
Experience
- 4+ years' experience in a clinical research setting.
- Requires knowledge and utilization of MS Office, Salesforce, REDCap Cloud, Zelta EDC platforms.
- Requires GCP and HSP training certificate per policies and procedures.
Knowledge, Skills, Abilities
- Demonstrated ability to write clear and complete assignments with attention to detail and high degree of accuracy. Strong interpersonal skills.
- Must be able to manage multiple study timelines, sites, and subscriber's commitments.
- Experience analyzing and interpreting written material and quantitative data to draw conclusions and make recommendations based on that data preferred
- Demonstrated proficiency in accessing information stored in large data systems.
Requirements
- Bachelor's degree, preferably in life sciences, public health, health services research or related area and or equivalent experience
- 4+ years' experience in a clinical research setting
- Knowledge and utilization of MS Office, Salesforce, REDCap Cloud, Zelta EDC platforms
- GCP and HSP training certificate per policies and procedures
- Demonstrated ability to write clear and complete assignments with attention to detail and high degree of accuracy
- Strong interpersonal skills
- Must be able to manage multiple study timelines, sites, and subscriber's commitments
- Demonstrated proficiency in accessing information stored in large data systems
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.