Job
Description
Lead Data Manager - ERT Legacy In addition to ensuring high quality data is provided to the Sponsors, the Lead Data Manager takes an active role in developing employees by providing mentoring and training on Clario processes and systems, and oversight and support to ensure DM staff successfully perform their daily duties. ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee assigned team: Direct the hiring, orientation, and training for the Clinical Data Management team members. Perform routine employee evaluations. Mentor and develop employees to prepare them for future growth opportunities within the company. Provide mentoring and organize training on new equipment, processes, or systems, including new hire orientation and introduction. Organize the process to ensure that the team s data management files are current and complete. Support routine status meetings with Sponsor/CRO and internal teams for your staff. Monitor the productivity and quality of the Clinical Data Management team: Develop method to track and report key quality indicators, productivity, successful data delivery, and query metrics. Conduct routine reviews with Managers, Supervisors and staff on production and key quality indicators. Support the assigned employees in setup of edit checks and proper auctioning of edit check output Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns. Define the Data Management Plan (DMP) through collaboration with clients, Project Management and Account Management. Through interactions with the Sponsor and Clinical Data Programming department, provide support to the DM team members in development, review, and finalization of data transfer requirements. Ensure the quality of study set-ups by participating in the review and approval process for all Data Management owned modules. Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times. Assist in the preparation of monthly reporting by providing metrics as required Develop, review and revise Standard Operating Procedures, Standard Work Instructions, Job Descriptions, and Departmental Training as needed. Create and or/review and approve SOPs and SWIs to ensure best practices are defined and followed during the lifecycle of a study. Assist Business Development and Quality Assurance with internal and external client meetings and audits and support Clinical Data Management team at such meetings. OTHER DUTIES AND RESPONSIBILITIES: Support clear and effective communication with Sponsor and other Clario departments in the single projects (e.g. Project status, timelines, etc.) Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation Job Profile Job Description Lead in resolving Quality Event issues related to study-specific data management activities Work with the Director to develop training programs Administer training as needed QUALIFICATIONS AND SKILLS NEEDED: Education : BS/BA degree in Life Sciences or related field preferred Experience : 5 + years Data Management related experience Prior leadership experience a plus Proficient in Microsoft Office applications Strong organizational, interpersonal, time-management, and problem-solving skills with good leadership abilities Ability to manage multiple priorities Strong attention to detail Previous SAS or SQL exposure or experience a plus Excellent communication skills and ability to work well with others Ability to communicate effectively in English We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
