Senior Clinical Database Designer I

Everest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Senior Clinical Database Designer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.

Key Accountabilities:

• Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities.
• Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
• Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline. Maintain database design timelines and promote good project management practices.
• Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities.
• Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trials.
• Author and review the Data Validation Specifications for assigned projects.
• Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers. Coordinate and oversee the UAT process for clinical databases.
• Design and review patient Case Report Forms and database schema. Test data capture/entry screens through UAT.
• Participate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetings.
• Participate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes.
• Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems.
• Provide input to all data management procedural documents.
• Plan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements.
• Review the Data Management Plan (DMP) for assigned projects.
• Review data, issue and resolve queries. Assist the Lead Data Manager, sponsor or Investigative Site with resolving queries.
• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
• Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team members.
• Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines.
• Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.
• Participate in and contributes to Clinical Data Management initiatives.
• Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports.

Qualifications and Experience:

• B.Sc. in Biological Sciences or Computer Science.
• Five years' related experience.
• Two to three years developing Inform and/or Medidata Rave (or similar) clinical data bases. Previous Clinical Data Management experience in both paper based and electronic data capture systems.
• Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
• Proven leadership and interpersonal skills in complex team situations.
• Excellent presentation skills and the ability to build relationships with both internal and external clients.
• Must be well organized and able to work independently and manage multiple projects/tasks appropriately.
• Demonstrated ability to effectively organize and integrate the activities of information processing personnel.

Benefits & Compensation:

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $ 90,000 - $130,000.