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.