Registry Manager

About CorEvitas

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. Providing curated data while leveraging a cloud-based secure technology platform enables the company to aggregate and process longitudinal data at scale and handle a broad spectrum of clinical and patient reported outcomes. Leveraging these data and analytic services, CorEvitas helps biopharmaceutical companies demonstrate the value of their products to clinicians, patients, payers, and regulators.

We operate eight major autoimmune and inflammatory registries across the US, Canada, and Japan, collecting data from nearly 500 clinical sites. In addition to our registry operations, we consist of additional specialty teams: HealthiVibe, the patient experience unit, complements and strengthens our disease registries by providing market-leading expertise in supporting innovative, evidence-based patient engagement initiatives across the entire product lifecycle. Our HealthUnlocked technology platform hosts over 1.4 million patients in hundreds of condition-specific communities and significantly enhances the depth and breadth of patient experiential data. Through our Health iQ division, CorEvitas has access to a broad range of UK-based and international data sets enabling us to understand market access issues, including clinical utilization, capacity planning, and cost optimization. Vestrum Health, a leader in data analytics of retinal practice EHR, provides insightful views of retinal diseases across the drug life cycle. CorEvitas is an Audax Private Equity portfolio company.

Your Responsibilities Will Include:
Responsible for day-to-day operations at assigned participating sites

Your Key Strengths Include

• 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 Mgt. of 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.

Additional Experience and Qualifications

• Demonstrated ability to write clear and complete assignments with attention to detail and high degree of accuracy. Strong interpersonal skills.
• Requires knowledge and utilization of MS Office, Salesforce, REDCap Cloud platforms
• Requires GCP and HSP training certificate per company policies and procedures.
• Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
• Must be able to manage multiple study sites

Required:

• 4 years’ experience in a clinical research setting.
• Bachelor’s degree, preferably in life sciences, public health, health services research or related area and or equivalent experience. Preferred:
• Advanced degree, Research, and regulatory certifications, i.e.., RAPS or ACRP certificates
• 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, 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.

Work Environment

• Remote position
• Must be able to remain in a stationary position for an extended period.
• Must be able to travel in the US 15% of the time

CorEvitas is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply