Registry Manager

Thermo Fisher Scientific • Waltham, MA

23h • Remote

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. As part of our clinical research portfolio, our evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on – now and in the future. Location - Remote Based 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.

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.
• Requires knowledge and utilization of MS Office, Salesforce, REDCap Cloud, Zelta EDC platforms.
• Requires 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.

Nice To Haves

• Advanced degree, Research, and regulatory certifications, i.e., RAPS or ACRP certificates preferred
• Experience analyzing and interpreting written material and quantitative data to draw conclusions and make recommendations based on that data preferred

Responsibilities

• 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.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level