Senior Registry Manager - CorEvitas

Thermo Fisher Scientific • Waltham, MA

4d • 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 CorEvitas 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. CorEvitas is the built-for-purpose gold-standard provider of real-world evidence. CorEvitas provides a holistic approach to capturing real-world data through patient-centered solutions including clinical registries, patient insight studies, biospecimen solutions and specialty electronic health record (EHR) data. We operate 13 major autoimmune and inflammatory registries across the US, Canada, Europe, and Japan, collecting data from nearly 600 clinical sites.

Requirements

• Master’s degree, preferably in life sciences, public health, health services research or related area or bachelor’s degree and equivalent experience.
• 6 + years’ experience in a clinical research setting.
• Requires GCP and HSP training certificates per policies and procedures.
• Experience analyzing and interpreting written material and quantitative data to draw conclusions and make recommendations based on that data.
• Demonstrated proficiency in accessing information stored in large data systems.
• Demonstrated experience using computer applications, including Microsoft Word, Excel spreadsheet and PowerPoint presentation programs, REDCap, Zelta, Salesforce
• Requires GCP and HSP training certificate per company policies and procedures.
• Must be able to manage multiple study timelines, sites, and subscriber's commitments.

Nice To Haves

• Advanced degree, Research, and regulatory certifications, i.e., RAPS or ACRP certificates

Responsibilities

• Responsible for full oversight and management of day-to-day activities within the entire registry, while utilizing key metrics on execution and performance in its entirety
• Direct and oversee assigned registry and registry team
• Maintain strong relationships with participating sites
• Enforce appropriate execution of IRB approved protocol, ensure full regulatory compliance is followed with each site.
• Ensure and monitor data queries within assigned registries are resolved in a timely manner
• Strategize new business development in expansion of participating providers, sites and or registries
• Supervising to include Organizing workflow to accomplish established objectives; delegating responsibilities; training, mentoring, and evaluating team member development.
• Appraise performing sites in a timely yet appropriate manner
• Submit by the 1st of each month key performance indicators of sites participation and enrollment for assigned registry to the Director of Registry Mgt.
• Work alongside key CorEvitas departments to build out strategies that increase provider and subscriber participation in existing registries and create new opportunities in additional therapeutic areas
• Participate in all interactions with current subscribers to appropriately communicate status of enrollment per subscriber agreement.
• Drive and lead input to desired changes as related to the CorEvitas Registry protocol, questionnaires, site performance metrics and assessments and EDC systems
• Work alongside key leadership to balance resource allocation against achievement of company goals.
• Design and implement recruitment strategies for sites and investigators; work with principal investigators to overcome enrollment barriers and suggest best practices

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: Senior