Director, 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 with corporate headquarters in Ontario, Canada, US headquarters in New Jersey, and additional offices in Asia and Europe.

About the role

We are seeking a committed, skilled, and customer-focused Director, Clinical Data Management to join our team. This role can be based on-site in Bridgewater, New Jersey, or remotely from a home-based office anywhere in the United States in accordance with our Work from Home policy.

Responsibilities

• Establish and control 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 budget and resource plans; perform ongoing assessment and control for the utilization of resources and budget.
• Achieve divisional objectives within the agreed-upon budget.
• Manage client project portfolios in conjunction with other corporate executives and maintain strong client relations.
• Assist in the development of project bids for new projects.
• Ensure timely availability of clinical data capture instruments and databases; contribute to their 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, data management, storage, and QC/QA.
• Integrate Clinical Data Management operations with the requirements of Quality Assurance and Compliance, Project Management, Clinical Operations, Biostatistics, Statistical Programming, and Medical Writing functional areas to assure cooperative realization of corporate objectives and optimize productivity and effectiveness.
• Perform competitive benchmarking of clinical data operations to ensure data management techniques and procedures used are best-in-class.
• Plan, direct, and follow up on the establishment of data management guidelines and procedures in line with industry good data management practices.
• Participate in corporate efforts to investigate, establish, and implement new and advanced systems, standards, and procedures to improve data capture and management effectiveness.
• Recruit, train, motivate, and develop staff to ensure high levels of performance with strong professional and technical expertise; complete annual and semi-annual performance reviews.
• Plan, implement, and oversee staff training and development processes.
• Plan, manage, and control resources to effectively fulfill unit and corporate missions, goals, and policies.

Requirements

• M.Sc. in Computer Science, Biostatistics, Mathematics, or Life Sciences. Lower academic degrees may be acceptable with proven abilities and expertise.
• At least 15 years of Clinical Data Management experience, including a minimum of 3 years of line management experience.
• Comprehensive knowledge of systems, programs, and operations required to collect, store, perform QC/QA, and process clinical data to meet international standards including 21 CFR Part 11 and ICH guidelines.
• Experience leading a team with exceptional people management skills, including the ability to interact successfully and communicate effectively with personnel at all levels.
• Experience in the design and implementation of Standard Operating Procedures for Clinical Data Management.
• Experience with client relationship management and developing future business is preferred.

Skills

• Demonstrated ability to effectively manage clinical/medical information and organize and integrate the activities of information processing personnel.
• Excellent analytical and creative problem-solving skills.
• Strong client relationship management skills.
• Commitment to process improvement.
• Ability to develop and implement strategic operations and processes to ensure peak performance and gain efficiencies.
• Providing technical expertise and ability to manage high-profile projects.
• Effective communication, both orally and in writing, with personnel at all professional and administrative levels.
• Leading or participating in the evaluation and implementation of new systems, processes, and standards.
• Leading and directing the development and implementation of new standards and procedures to improve the effectiveness and efficiency of clinical data management.

Pay

Estimated salary range: $180,000 - $210,000.