Manager, Clinical Data Management

Manager, Clinical Data Management Maintains overall responsibility for the quality and completion of all projects within Data Management.Staffing, employee relations and establishment of performance goals and objectives to ensure the accurate and timely processing of data.Defines departmental standards in reference to corporate processes, procedures and guidelines related to Data Management. Approving all final databases and database documentation. Developing criteria for data validation, data presentation, edit specifications and discrepancy resolutions. Participate on interdepartmental protocol teams and function as an advisor on all protocols and tasks assigned to the organizational units under supervision and review standard operating procedures for Clinical Data Management functions. Aid in finalizing and implementing CDM Standing Operating Procedures (SOPs), templates and forms. Participate in comprehensive training and education of clinical data management policies, SOPs, templates and forms. Guide the development of CRF standards with focused effort on Adverse Event and Serious Adverse Event (SAE) information. Play a role in gathering and developing user and functional requirements for Clinical Data Management systems.

Minimum Education & Experience Requirements:  BS/MS degree with 6-8 years experience or equivalent experience.Demonstrated knowledge of the data management and programming aspects of the pharmaceutical, biotechnology, and/or clinical research service industries. Advanced knowledge of DB management methodologies, specifically EDC Direct line management experience

Knowledge/Skills Needed: Excellent written and oral communication skills, interpersonal skills and proven team building techniques. Must be highly organized and demonstrate close attention to detail. Must also possess a working knowledge of medical terminology, and have the ability to provide solutions to complex issues and work with minimal supervision. Compliance with regulatory, protocol requirements, Standard Operating Procedures (SOP) and Good Clinical Practices (GCP). Excellent oral, written, and presentation skills. Excellent negotiation skills and ability to work through difficult conversations/situations.

Personal Attributes Needed: Self-motivated, flexible, independent thinking, problem solver, ability to work in a fast paced/demanding environment, ability to prioritize and/or multi-task, collaborative team member