Director, Clinical Data Management

Everest-Clinical-Research; Bridgewater Township (NJ); On-site; USD 180,000 - 210,000; Full time

Job summary

Everest Clinical Research seeks a Director, Clinical Data Management for our Bridgewater, New Jersey on-site location, or remotely from a home-based office anywhere in the United States under our Work from Home policy.

You will establish and control clinical data operations to deliver complete, valid, and secure databases, while managing budgets, resources, and client projects; ensuring data capture instruments and databases are timely and compliant with 21 CFR Part 11 and ICH guidelines.

Qualifications

• A MSc in Computer Science, Biostatistics or Mathematics, or Life Sciences.
• At least 15 years of Clinical Data Management experience including a minimum of 3 years line management.
• Comprehensive knowledge of systems, programs, and operations to collect, store, QC and QA clinical data to meet international standards including 21 CFR Part 11 and ICH guidelines.
• Proven ability to lead a team and interact with personnel at all levels; strong analytical and problem-solving skills.

Responsibilities

• Establish and control clinical data operations to provide complete, valid, safe, and secure databases meeting regulatory requirements.
• Develop and manage CDM budget and resource plans; achieve divisional objectives within budget; manage client project portfolios and relations.
• Ensure timely availability of data capture instruments and databases; integrate CDM with QA/Compliance, PM, Clinical Operations, Biostatistics, and other functions.
• Lead development and implementation of SOPs for Clinical Data Management and pursue continuous process improvements.

Job description

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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

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 Director, Clinical Data Management for our Bridgewater, New Jersey on-site location, or remotely from a home-based office anywhere in the United States in accordance with our Work from Home policy.

ACCOUNTABILITIES:

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 and 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. Maintain strong client relations. Assist in the development of project bids for new projects.

Ensure timely availability of the clinical data capture instruments and databases, and 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 and QA.

Integrate the operations of Clinical Data Management with the requirements of the Quality Assurance and Compliance, Project Management, Clinical Operations, Biostatistics, Statistical Programming, and Medical Writing functional areas to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management.

Perform competitive bench marking of clinical data operations to ensure that data management techniques and procedures used are the best in the class.

Plan, direct, and follow up on the establishment of data management guidelines and procedures which are in line with industry good data management practices.

Participate and contribute to the corporate efforts, in investigating, establishing, and implementing new and advanced systems, standards, and procedures to improve the effectiveness of data capture and management.

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 process.

Plan, manage, and control resources to effectively fulfill unit and corporate missions, goals, and policies.

QUALIFICATIONS:

A M.Sc. in Computer Science, Biostatistics or Mathematics, or Life Sciences. Lower academic degrees will be acceptable with proven abilities and the level of expertise required for the job.

At least 15 years’ of Clinical Data Management experience including a minimum of 3 years line management experience.

A comprehensive knowledge of the systems, programs, and operations required to collect, store, perform QC and 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 in dealing with the various functional areas within the company including the ability to interact successfully and communicate effectively with personnel at all levels within the organization.

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.

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; excellent client relationship management skills; commitment to process improvement; ability to develop and implement strategic operations and process to ensure peak performance and gain efficiencies; providing technical expertise and ability to manage high profile projects; communicating effectively, 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.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com .

Estimated Salary Range: $180,000 - 210,000.

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
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.