Clinical Data Specialist

Intuitive•Seattle, WA

About The Position

The Clinical Data Specialist manages, maintains, and supports clinical treatment planning for multiple clinical studies and registries. The role requires an understanding of data review, oversight, and management systems, as well as experience handling different data types, including EDC and DICOM data. The specialist supports clinical investigations in accordance with departmental operating procedures and oversees the quality and management of clinical trial digital assets. The position involves screening study candidates using medical histories, diagnostic findings, and clinical data; coordinating individualized treatment plans with physicians and clinical staff; and collecting, managing, reviewing, and cleaning study data. The specialist also oversees outsourced imaging activities and vendor deliverables, serves as a contact among sponsors, clinical teams, sites, and vendors, and supports study operations and statistical review through datasets, listings, data specifications, and transfers. The role supports multiple studies simultaneously and contributes to the development and maintenance of data-management procedures.

Requirements

Bachelor of Science or Bachelor of Arts degree in a scientific or medical field.
At least 3 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 procedures as new 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 skills.
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 other 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 updates or adjustments.
Identify opportunities to streamline treatment-planning processes and implement best practices.
Manage external vendors providing digital imaging software solutions.
Act as the sponsor's main point of contact for imaging data acquisition activities outsourced to clinical vendors, including CROs and imaging analysis vendors.
Coordinate communications among the clinical team, vendors, sponsor, and other parties regarding site activities and trial progress.
Manage timelines and deliverables and oversee outsourced image upload, transfer, and analysis activities.
Lead regular cross-functional meetings to review treatment-planning data.
Work with stakeholders to define data-quality KPIs and ensure they are met throughout studies.
Support study operations and analysis groups by helping create datasets and listings that correlate patient outcomes with treatment-planning inputs.
Prepare data specifications and/or process data transfers 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.
Independently identify solutions to address company needs and objectives, including proactively resolving significant or unique issues in critical situations.