Intuitive Surgical, Inc

Clinical Data Manager

Intuitive Surgical, Inc$100K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 3-5 years of data management experience in medical device/pharmaceutical industry
  • Experience with EDC systems, preferably Medrio and Medidata Rave
  • Strong knowledge of Good Clinical Practices and clinical trial processes
  • Bachelor's degree in a scientific or medical field
  • Effective interpersonal and written communication skills

Responsibilities

  • Develop project-specific data management plans covering design and lifecycle management
  • Interpret protocol requirements for efficient electronic data capture (EDC) design
  • Create design specifications for clinical databases and edit checks
  • Validate EDCs at study level, developing requirements and test scripts
  • Provide clinical data management support for study operations and statistical analysis
  • Train users on EDC systems, including creating documentation and conducting sessions
  • Manage post-go live issues for multiple studies in a dynamic environment

Benefits

  • Market-competitive compensation packages including base pay, incentives, and equity
  • Opportunity for professional development and team collaboration
  • Supportive work environment focused on high-quality research
  • Access to training and resources for skill enhancement
  • Engagement in meaningful projects related to medical devices and clinical studies
Full Job Description
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. • 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. o Assist in defining and creation of data listings, including programming software to generate listings. o 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 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 possess in order to successfully perform in job) • 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. 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. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

About Intuitive Surgical, Inc

Intuitive Surgical, Inc. is an American corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System. The company is part of the NASDAQ-100 and S&P 500. Intuitive Surgical has installed more than 5,000 surgical systems worldwide, and has more than 4,000 employees.
Learn more about Intuitive Surgical, Inc
Size
9,793 employees
Market Cap
$93.6 billion
Industry
Net Income
$1 billion
Founded
1999
5 Year Trend
+16.1%
Revenue
$4.3 billion
NASDAQ

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