Job Description
Job Description: Job Description / Summary The Manager, Clinical Data Management is a full-time exempt position reporting to the Director, Clinical Data Management. PLEASE NOTE: Candidates must have a valid Green Card or U.S. citizenship. No visa sponsorship is available now or in the future. Must Have • 12+ years of hands-on data management experience. • 6-7 years of managerial experience, managing a team of at least 5 people. • 4+ years of experience in the CRO environment. • Excellent oral and written communication skills. • Ability to work in the PST time zone (flexible). • Willingness to travel 2-3 times a year when necessary. Responsibilities • Provide data management expertise to project teams, clients, and CROs, including study startup documents, data cleaning, DCF/query tracking, database QC, and SAE/AE reconciliation. • Oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and User Acceptance Testing. • Conduct cross-functional data reviews, identify issues, and track resolutions. • Innovate and implement new technologies for process improvements. • Ensure adherence to quality control procedures. • Write and update SOPs/training guidelines. • Facilitate internal study team, client, and CRO meetings. • Review study data quality, provide metrics, and report out-of-scope activities. • Manage timelines and resources to meet deadlines. • Identify and recommend solutions for process inefficiencies. • Assist in preparing proposals and budgets for new and ongoing projects. • Direct and manage team members, including training, resource assignment, and performance reviews. Education and Experience Requirements • 12 years of hands-on data management experience. • 6-7 years of managerial experience, managing a team of 5+ people. • B.S./B.A. in a science or technical discipline with 8 years of data management experience, or MS degree with 6 years of data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment. • Proficiency in SQL or SAS is desirable but not required. • Experience with various data collection and EDC systems. Knowledge & Skills Requirements • Excellent oral and written communication skills. • Ability to work collaboratively in a multi-disciplinary environment. • Good knowledge of FDA, EMA, ICH guidelines, and GCPs, especially related to data handling and processing. Salary and Benefits • Market rate compensation as base salary with all the benefits. Required Skills: • Biotechnology • Data Cleaning • Project Teams • Data Quality • SAS • User Acceptance Testing • Resolutions • Data Collection • Data Management • Salary • Checks • Communication Skills • Compensation • Timelines • Reviews • Metrics • Travel • Quality Control • Specifications • Education • Testing • SQL • Science • Training • Communication • Management Apply tot his job