Data Management Associate I

About CovarsaDx

CovarsaDx is a clinical research organization specializing in supporting clinical studies for in vitro diagnostics (IVD) and medical devices. The company collaborates closely with clients to design effective study strategies, provide expert advice, and offer adaptable support throughout the clinical trial process. The team strongly values collaboration, curiosity, accountability, and high-quality work that drives regulatory success and meaningful clinical research outcomes.

Role Overview

We are seeking a meticulous and collaborative Data Management Associate I to join our team remotely. This role involves supporting various clinical data management tasks for IVD and medical device studies, such as EDC (Electronic Data Capture) build and maintenance, reviewing data, resolving queries, protocol analysis, and managing study documentation. The position offers an excellent environment for learning, clear communication, and continual enhancement in partnership with experienced data management leaders and cross-functional teams.

Responsibilities

• Assist with clinical data management duties including protocol review, case report form (CRF) development, database setup, data validation, adverse event (AE) tracking, reconciliation, and preparation for database lock.
• Collaborate with clinical and statistical teams to support data review, safety updates, and other study-related outputs.
• Manage data validation tasks including transfer specifications, reconciliation activities, and query generation and resolution.
• Conduct user acceptance testing for electronic data capture systems, help design electronic CRFs, and support the creation and maintenance of data management standards and documentation.
• Address data discrepancies with clinical, SDTM, and biostatistics teams efficiently.
• Contribute to department initiatives, process optimizations, and adherence to data management best practices.

Qualifications and Experience

• Bachelor’s degree preferably in a scientific field or equivalent practical experience.
• Minimum of 3 years of proven data management expertise or at least 2 years hands-on experience with data management techniques and tools.
• Up to 1 year of industry exposure in pharmaceutical, medical device, combination product/device, IVD, research and development, clinical research, quality systems, or regulatory settings.
• Alternatively, a Master’s degree in data science, analytics, computer science, engineering, statistics, business, or related fields along with 2 years of demonstrated data management experience is acceptable.

Core Competencies

• Deep knowledge of data management methods, EDC programming, edit checks, and query processes.
• Self-motivated and adaptable with strong problem-solving capabilities and a solution-driven approach.
• Excellent organizational skills, capable of juggling multiple priorities and deadlines.
• Effective and clear communication skills, fostering constructive feedback.
• Understanding of clinical trial regulatory frameworks, particularly for IVD and medical device studies.
• Working familiarity with ICH guidelines, Good Clinical Practice (GCP), and FDA regulatory requirements.
• Strong interpersonal, collaboration, and presentation capabilities.
• Ability to evaluate data integrity risks and contribute insightful data management perspectives.
• Competence in making sound decisions under fast-paced conditions and adapting to changing priorities.

Work Environment and Physical Requirements

• This is a home-based remote position with a work setup conducive to focused and productive work.
• Work hours align with standard business practices; additional hours may occasionally be necessary to meet crucial deadlines.
• Travel may be required occasionally, including trips lasting five or more consecutive days by plane or ground transport.

Compensation and Benefits

• Annual salary range between $65,000 and $80,000, commensurate with skills and experienced levels.
• Medical, vision, and dental insurance coverage.
• 401(k) retirement plan with company matching contributions.

Equal Opportunity and Accessibility

We encourage applications even from candidates whose experience may not perfectly fit every listed qualification but who possess strong related skills and a learning attitude. We are committed to equal opportunity in employment, selecting candidates based on merit, qualifications, and ability without discrimination based on gender, marital status, race, religion, color, age, disability, sexual orientation, or veteran status. Accommodation requests during application or interview can be addressed by contacting HR directly.