Manager of Clinical Data Standards, Toronto/Markham, Ontario, Canada or Little Falls, New Jersey, USA Location (on-site or remote)
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. 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 Manager of Clinical Data Standards for our Toronto/Markham, Ontario, Canada or Little Falls, New Jersey, USA location (on-site or remote).
- Ensure the Statistical Programming organization’s awareness of and compliance with the latest published electronic regulatory submissions standards, including, but not limited to:
- CDISC Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML.
- Controlled Terminology (CT) published by CDISC, National Cancer Institute (NCI), and other organizations for use in clinical trials.
- Electronic Common Technical Document (eCTD), Study Data Standards documents, and any other relevant electronic submissions guidance issued by regulatory agencies such as United States Food and Drug Administration (FDA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), and others.
- Develop and maintain a library of metadata specification templates and tools to enable the efficient production of regulatory submission-compliant databases.
- Participate in ongoing review of departmental processes to ensure that deliverables are produced efficiently while remaining in compliance with regulatory submission standards.
- Review and approve the draft of SDTM and ADaM specifications prior to release of the specifications to clients and prior to production of SDTM and ADaM databases.
- Develop and deliver trainings on CDISC and regulatory submissions topics.
- Identify, train, and supervise (directly or indirectly) Clinical Data Standards experts within the Statistical Programming organization to contribute as Subject Matter Experts (SMEs) to the Clinical Data Standards objectives of the Statistical Programming organization.
- Actively participate and contribute to the Everest management team activities/function, including but not limited to the following:
- Perform strategic planning and carry out plans for the continued development and improvement of overall Everest performance.
- Discuss and set annual corporate level goals/objectives, enable or contribute to the achievement of these goals/objectives.
- Contribute to the up-keeping of the positive, professional, high performing, and productive work environment.
- Monitor and ensure compliance/adherence to corporate governing documents (policies, SOPs, Work Instructions, working Templates and Checklists).
- Continue to build client relationships and grow Everest brand with them.
- Perform business analysis and benchmarking in each business area as well as at the corporate level, find room for continuous improvement.
Qualifications and Experience:
- Must have a M.Sc., M.A. or higher in Statistics, Computer Science, or relevant fields with 6 years of clinical research experience.
- Requires demonstrated experience implementing CDISC standards to specify, program, and validate SDTM and ADaM-compliant databases for numerous therapeutic areas.
- Requires demonstrated experience supporting electronic regulatory submissions of clinical trial data for individual studies and integrated safety and efficacy analyses.
- Experience with multiple regulatory agencies preferred (FDA, PMDA, etc.).
- Experience with developing and delivering training curricula and governing documents (Standard Operating Procedures, Work Instructions, Templates, etc.) preferred.
- Must have an in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.
- Exceptional people management skills with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts.
- Exceptional written communication and presentation skills.
- Travel level specification: this position may require up to 10% business travel.
How to Apply:
Please send your application along with cover letter to the applicable country email address:
To find out more about Everest Clinical Research and to review other opportunities, please visit our WEB site 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.