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

* 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.