Note: The job is a remote job and is open to candidates in USA. Everest Clinical Research is a full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. The Director, Clinical Data Management will lead clinical data operations, budgets, resources, client portfolios, data systems, quality processes, and staff development while ensuring regulatory and corporate requirements are met.
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 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
Skills
- 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
- 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
- Experience with client relationship management and developing future business is preferred
Benefits
- Remote work from a home-based office anywhere in the United States in accordance with the Work from Home policy
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