Manager, Clinical Data Management in a CRO - Full Time REMOTE, some travel

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. Originally posted on Himalayas