Clinical Data Specialist

Intuitive•Seattle, WA

4d•$124,900 - $179,700•Remote

About The Position

The Clinical Data Specialist manages, maintains, and supports clinical treatment planning for multiple clinical studies and registries. The role requires understanding data review, oversight, and management systems, and adherence to departmental operating procedures for clinical investigations. The specialist manages varied data types, including EDC and DICOM data, and supports operational management and quality control of clinical-trial digital assets. Strong organization, attention to detail, and effective communication with stakeholders and medical staff are essential. The specialist assesses patient or subject records and clinical data to identify eligible study participants, supports individualized treatment-plan development and revision, and collects, manages, and reviews study data. The role also coordinates external vendors providing imaging software and services, oversees outsourced imaging activities and deliverables, and serves as a contact among clinical teams, vendors, sponsors, and other parties. Additional work includes supporting data specifications and transfers, preparing datasets and listings, data cleaning and query management, contributing to procedures, and managing activities across multiple studies.

Requirements

Bachelor of Science or Bachelor of Arts degree in a scientific or medical field.
3–5 years of data management experience, with a proven track record working on a medical device focused on COPD.
At least 3 years of experience with interventional pulmonology studies.
Experience with CT imaging.
Experience adhering to established operating procedures and creating new procedures as needs arise.
Knowledge of Good Clinical Practices, clinical research, clinical-trial processes, and related regulatory requirements and terminology.
Medical knowledge related to medical devices for lung interventions.
Expertise in collecting and reviewing medical images, procedure videos, and radiology reports.
Excellent interpersonal skills and effective written communication.
Ability to work well in a team and independently with minimal guidance.

Nice To Haves

Experience with statistical software.

Responsibilities

Assess patient or subject medical histories, diagnostic findings, and clinical data to identify eligible participants and document inclusion and exclusion criteria.
Collaborate with physicians, clinical staff, and stakeholders to create and revise individualized treatment plans.
Collect, record, and manage study data, ensuring accuracy and completeness.
Track treatment-plan execution, identify potential issues or deviations, and coordinate timely updates or adjustments.
Identify opportunities to streamline treatment-planning processes and implement best practices.
Manage external vendors providing digital imaging software solutions and serve as the sponsor’s main contact for outsourced imaging-data acquisition.
Serve as a point of contact among clinical teams, vendors, sponsors, and other parties regarding site activities and trial progress.
Manage timelines and deliverables and oversee outsourced image upload, transfer, and analysis activities.
Lead cross-functional meetings to review treatment-planning data and collaborate on data-quality KPIs.
Support study operations and analysis groups by creating datasets and listings that correlate patient outcomes with treatment-planning inputs.
Develop data specifications and/or process data transfers in preparation for statistical review.
Clean and review clinical data, including query management and data-listing review.
Manage activities for multiple studies simultaneously.
Contribute to the development and maintenance of departmental operating procedures for data management.
Proactively identify solutions to significant and unique issues in critical situations.