Clinical Data Manager at Intuitive — Sunnyvale, CA

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

Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the

role. Additional job duties may be determined by functional people manager)

• 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.
• Program/Configure eCRFs, Edit Checks, Visits and Schedule of Events in EDC system.
• 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

Required Skills and Experience (Specific skills, knowledge, and experience that an individual must

possess in order to successfully perform in job)

• 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.

Required Education and Training (As applicable - Specific education and training that an individual must

• BSc/BA in a scientific or medical fiel

Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state “none”)

None

Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not

required to perform the job, but are desirable to have)

• Desired to have experience with SAS software.
• Desired to have 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.

Mandatory Notices