Job Details
Description
The Clinical Research Data Manager is responsible for all clinical research data management activities while following Good Clinical Practice (GCP) and applicable regulations. This role works collaboratively with study team members and other internal and external partners to ensure high quality data collection, data management, and data processes.
Responsibilities
- Manage all aspects of clinical research data through all trial phases including selection of appropriate clinical data, processes to review data, reporting of data metrics to stakeholders, and site closeout activities.
- Establish timelines for trial milestones such as database go-live, interim analyses, database lock, and archiving of data.
- Contribute to Case Report Form (CRF) design using data collection best practices and standards.
- Assist with the configuration of the Electronic Data Capture (EDC) System to align with study requirements.
- Maintain project-specific data management plans that define processes such as data coding, reporting, transfers, database locks, and data workflows.
- Define and implement data review strategies to ensure consistency, integrity and accuracy based on project specific guidelines.
- Generate data extracts, metrics, and summaries for cross-functional partners.
- Identify and resolve data issues by reviewing for consistency, completeness, and trends.
- Collaborate with clinical partners to ensure appropriate oversight and quality of data collection.
- Contribute to clinical protocol development, study reports, regulatory submissions, or other controlled documentation.
- Conduct data management meetings with study team partners.
- Participate in User Acceptance Testing (UAT) to ensure study requirements are met.
- Assist with database revisions when required and minimize impact to existing data.
- Maintain current data management documentation using the quality and document management systems.
- Track the flow of data including EDC entry and external transfers.
- Perform quality control audits to ensure accuracy, completeness, and proper usage of clinical systems and data.
- Train study personnel on data management systems and processes.
- Perform other duties as assigned.
Qualifications - Bachelor's degree in Life Sciences.
- Minimum of 4 years relevant clinical research experience.
- Experience with Good Clinical Practice (GCP).
- Able to work independently and in remote settings.
- Ability to thrive in a fast-paced and dynamic company work environment.
- Detail oriented with ability to deliver high quality output consistently and on time.
- Ability to thrive in times of change while adhering to cultural focus on People and Patients.
- Requires the ability to interact with others in complex situations while preserving
- relationships.
- Applies knowledge to align with other stakeholders on desired departmental outcomes.
- Proficient with electronic databases used for clinical trials.
- Strong clinical process acumen.
Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $115,000 - $150,000 A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.