Manager, Clinical Data Management

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 committed, skilled, and customer-focused individuals to join our winning team as Manager, Clinical Data Management for our Little Falls, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Key Accountabilities:

• Assist with establishing and controlling clinical data operations to provide complete, valid, safe, and secure databases which meet corporate and regulatory clinical data requirements.
• Develop and manage clinical data management resource plans and perform ongoing assessment and control for the utilization of resources.
• Manage client project portfolios in conjunction with other corporate executives. Maintain strong client relations. Assist in the development of project bids for new projects.
• Assure the timely availability of the clinical data capture instruments and databases, and contribute to its completeness, validity, and effectiveness for use in product development, local registration, and support by planning and directing the integration of clinical case report form design, database definition, database administration, data entry, and QC.
• Assist with integrating the operations of the Clinical Data Management with the requirements of project management, biostatistical, and medical writing groups to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management.
• Assist with performing competitive benchmarking of clinical data operations to ensure that data management techniques and procedures used in the unit are the best in the class.
• Plan, direct, and follow-up on the establishment of unit guidelines or procedures in line with industry good data management practices in case report form design, database definition, data processing, data management, and QC.
• Participate in and contribute to the corporate efforts in investigating, establishing and implementing new and advanced systems, standards and procedures to improve the effectiveness of the data capture and management.
• Recruit, train, motivate and develop staff to assure high levels of performance and of professional and technical expertise.
• Assist with planning, managing, and controlling resources to effectively fulfill unit and corporate missions, goals, and policies.

Qualifications and Experience:

• B.Sc. or higher in Biological Science, Computer Science, Biostatistics or Mathematics.
• Six years’ related experience.
• A comprehensive knowledge of the systems, programs, and operations required to collect, store, QC, and process clinical data.
• Demonstrated ability to effectively manage medical information and organize and integrate the activities of information processing personnel.
• Communicate effectively, orally and in writing, with personnel on all professional and administrative levels.

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)