Senior 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 Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

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 Principal Clinical Data Manager for our Bridgewater, 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:

1. Assist with establishing and controlling clinical data operations to provide complete, valid, safe, and secure databases which meet corporate and regulatory clinical data requirements.
2. Develop and manage clinical data management resource plans and perform ongoing assessment and control for the utilization of resources.
3. Manage client project portfolios in conjunction with other corporate executives. Maintain strong client relations. Assist in the development of project bids for new projects.
4. 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 CRF design, database definition, database administration, data entry, and QC.
5. 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.
6. 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.
7. 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.
8. 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.
9. Recruit, train, motivate and develop staff to ensure high levels of performance and of professional and technical expertise.
10. Assist with planning, managing, and controlling resources to effectively fulfill unit and corporate missions, goals, and policies.

Qualifications and Experience:

1. A B.Sc. or higher in Biological Science, Computer Science, Biostatistics or Mathematics.
2. Twelve (12) years’ related experience.
3. A comprehensive knowledge of the systems, programs, and operations required to collect, store, QC, and process clinical data.
4. Demonstrated ability to effectively manage medical information and organize and integrate the activities of information processing personnel.
5. Communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
6. Contribute to the investigation and implementation of new systems.
7. Lead and direct the development and implementation of new standards and procedures to improve the effectiveness of the data management process.
8. Participate in and contribute to the corporate efforts in establishing and implementing new systems and standards (preferred).

 

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 sele