Staff Clinical Data Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee all clinical data management functions for designated medical device studies from the initiation phase to the closure of the database, ensuring the accuracy, integrity, and readiness for inspection of data.

• Create, develop, and sustain clinical databases, which includes drafting, reviewing, and approving both database and edit check specifications.

• Supervise the construction and updates of electronic data capture systems, including the execution and documentation of user acceptance testing.

• Formulate and implement data review strategies; lead ongoing data cleaning, query generation, and query resolution efforts in collaboration with internal teams and external partners.

• Examine and interpret data listings and metrics to support trial oversight, operational decisions, and adherence to protocols.

• Manage timelines, deliverables, and performance metrics related to data management to ensure consistency with study plans and milestones.

• Coordinate daily data management tasks with clinical operations, biostatistics, medical teams, and external vendors to guarantee timely and compliant data delivery.

• Participate in process enhancement initiatives, the development of standard operating procedures, and preparation for audits and inspections as the organization expands.

⛳️ Requirements

• A Bachelor’s degree in a technical and/or scientific field.

• More than 4 years of experience in clinical data management.

• Practical experience with Medidata Rave electronic data capture systems.

• Familiarity with clinical data standards and regulatory requirements, including Good Clinical Practice and relevant international guidelines.

• Experience in clinical data management specifically supporting medical device clinical trials (preferred).

• Familiarity with Medidata Imaging and JReview administration (preferred).

• Knowledge of Clinical Data Interchange Standards Consortium standards (preferred).

• Experience in overseeing contract research organizations or external vendors for data management activities (preferred).

🏝️ Benefits

• Equal opportunity employer.

• Opportunities for professional development.