Clinical Database Designer, Toronto/Markham, Ontario, Canada or Little Falls, New Jersey, USA (on-site) Location
Everest Clinical Research ("Everest") is a full-service 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. Operating primarily in North America, with headquarters located in Markham (Greater Toronto Area), Ontario, Canada and an office in Little Falls (Greater New York City Area), New Jersey, USA, 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 Clinical Database Designer for our Toronto/Markham, Ontario, Canada or Little Falls, New Jersey, USA, (on-site) location.
Assists Clinical Data Management in planning, directing, and managing the clinical data management operations for database design and study start-up. These tasks are performed in a timely and accurate manner to ensure a high level quality and productivity in Clinical Database Design.
- Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
- Review the protocol and associated reference material and contribute to the development of the 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 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 databases designed by other designers. Coordinate and oversee the UAT process for clinical databases.
- 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:
- Minimum Bachelor’s degree in Biological Sciences or Computer Science.
- At least 5 years’ experience in a clinical research capacity.
- At least 2 to 3 years' experience 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.
- Knowledge of clinical trial processes and procedures.
- Excellent analytical and creative problem solving, conflict resolution, communication, organizational, and multi-tasking skills.
- Comprehensive skills in MS Office applications.
How to Apply:
Please send your application along with cover letter to the applicable country email address:
Toronto, Ontario, Canada: [email protected]
Little Falls, New Jersey, USA: [email protected]
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.