临床数据管理主管（CRO 全职远程工作，部分旅行）

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