Clinical Data Manager

Intuitive•Sunnyvale, CA

About The Position

The candidate will manage design, development, implementation, validation, maintenance, and support clinical databases related pre-market or post- market clinical studies/registries. The candidate will be responsible for adhering to the required departmental operating procedures regarding Data Management for clinical investigations. The position requires effective collaboration with clinical operation teams, supporting project goals, and ensuring high-quality research and database development.

Requirements

Minimum of 3-5 years of data management experience with a proven track record working in a medical device/pharmaceutical industry.
EDC system(s) experience (Preferably Medrio and Medidata Rave)
Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.

Nice To Haves

Experience with SAS software.
Medical knowledge as pertaining to medical devices for surgery.
Excellent Interpersonal skills
Work well in a team environment.
Work independently to carry out tasks with minimal guidance.
Effective written communication and interpersonal skills.

Responsibilities

Develop project specific data management plan that includes design, creation and lifecycle management of data collection, validation, reporting specification and usage guidelines.
Understand CRF design and interpret protocol requirements to efficient EDC design.
Create clinical databases design specifications including edit check specifications.
Experience with validation of EDCs at a study level including experience developing study requirements, test scripts, and UAT documentation.
Administration of existing EDC systems for multiple studies simultaneously.
Provide clinical data management support for study operations and analysis groups including the following.
Assist in defining and creation of data listings, including programming software to generate listings.
Data specifications and/or process data transfers in preparation for statistical review.
Training users on EDC systems. Includes create of training documentation and running training sessions for end users.
Data cleaning and review of clinical data. Including query management and data listing review.
Manage post-go live issues and requests.
Managing activities for multiple studies simultaneously in a dynamic environment.
Contribute to development and/or maintenance of departmental operating procedures for data management.
Proactive in understanding company needs/objectives and able to independently seek solutions. Works on significant and unique issues in critical situations and able to provide solutions proactively.