Clinical Data Specialist

Job Description

Primary Function of Position:

The candidate will manage, maintain and support clinical treatment planning for multiple clinical studies/registries. The candidate will have an understanding of data review, oversight, and management systems. The candidate will be responsible for adhering to the required departmental operating procedures for clinical investigations. The candidate will have experience managing a variety of different data types, including EDC data and DICOM data, etc. Ideal candidates will have had operational experience managing clinical trial digital assets, as well as oversight and QC of the data. This role demands excellent organizational skills, attention to detail, and the ability to communicate effectively with stakeholders and medical staff.

Roles and Responsibilities:

• Assess patient or subject medical histories, diagnostic findings, and clinical data to screen and identify eligible patients for ongoing studies, ensuring proper documentation of inclusion/exclusion criteria
• Collaborate with physicians, clinical staff, and other stakeholders to facilitate the creation and revision of individualized treatment plans for patients or study subjects.
• Collect, record, and manage study data as required, ensuring accuracy, completeness.
• Track the execution of treatment plans, identify potential issues or deviations, and coordinate timely updates or adjustments as needed.
• Identify opportunities to streamline treatment planning processes and implement best practices for improved patient care or study outcomes.
• Management of outside vendor(s) providing digital imaging software solutions. Serve as the Sponsor main point of contact for all imaging data acquisition activities outsourced to external clinical vendors (i.e. CROs and Imaging Analysis Vendors).
• Serve as a point of contact between the clinical team, vendors, sponsor, and other involved parties regarding site activities and trial progress.
• Manage timelines and deliverables. Oversee outsourced activities including image upload, transfer and analysis imaging clinical trials.

• Lead regular cross functional meetings to review treatment planning data. Collaborate with stakeholders to identify key performance indicators (KPIs) for data quality and ensure they are met throughout the study. Provide clinical data management support for study operations and analysis groups including the following.

• Assist in creating of datasets and listings to correlate patient outcomes to treatment planning inputs
• Data specifications and/or process data transfers in preparation for statistical review.

• Data cleaning and review of clinical data. Including query management and data listing review.
• 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

Qualifications

Skill, Experience, Education, Training:

• Minimum BSc/BA in a scientific or medical field
• Minimum of 3-5 years of data management experience with a proven track record working on a medical device focused on COPD.
• 3+ years experience with interventional pulmonology studies required.
• Experience with CT Imaging required
• Experience both adhering to set operating procedures and creating new procedures as new needs arise
• Excellent Interpersonal skills
• Work well in a team environment
• Work independently to carry out tasks with minimal guidance
• Effective written communication and interpersonal skills.
• Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Desired to have experience with statistical software.
• Required to have medical knowledge as pertaining to medical devices for lung interventions.
• Expertise with the collection and review of medical images and procedure videos and radiology reports required.

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.

Mandatory Notices

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. …