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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.
