Clinical Data Manager

Role Description

The candidate will manage design, development, implementation, validation, maintenance, and support clinical databases related to 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

• 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.

Qualifications

• 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.

Requirements

• BSc/BA in a scientific or medical field.

Preferred Skills and Experience

• 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.

Additional Information

• Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
• Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
• We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
• Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

Compensation

• Max. Salary Region 2: 152700 USD
• Max. Salary Region 1: 179700 USD
• Min. Salary Region 1: 124900 USD
• Min. Salary Region 2: 106200 USD

Ways of Working

• Remote - This job will be remote and/or the job is designed to be performed outside of the office. Employees will come onsite when requested by the leader.