Salary Range: $65,000 - $80,000. Compensation offered will reflect the skills and experience of the candidate.
Classification: Exempt
CovarsaDx is a clinical research organization (CRO) dedicated to supporting IVD (in vitro diagnostic) and medical device clinical studies. We partner with clients to deliver thoughtful study strategies, expert consultation, and flexible support as clinical trial needs evolve. Our team values collaboration, curiosity, accountability, and high-quality work that contributes to regulatory success and meaningful clinical research outcomes.
We are looking for a detail-oriented and collaborative Data Management Associate I to join our Data Management team. In this remote role, you will help support clinical data management activities across IVD and medical device studies, including EDC builds and maintenance, data review, query resolution, protocol review, and study documentation. You will work closely with experienced data management leaders and cross-functional study teams in an environment that values learning, clear communication, and continuous improvement. This is a great opportunity for someone who enjoys working with clinical data, solving problems, and contributing to research that supports high-quality study outcomes.
Key Responsibilities
- Support clinical data management activities, including protocol review, CRF development, database set-up, data validation, AE tracking, reconciliation, and database lock.
- Coordinate with clinical teams and statistical associates to support data review, safety updates, and related deliverables.
- Coordinate data validation activities, including transfer specifications, reconciliation, query generation, and resolution.
- Perform EDC user acceptance testing, support eCRF design, and contribute to data management standards and documentation.
- Resolve data issues with clinical, SDTM, and biostatistics teams.
- Support department standards, process improvements, and data management initiatives.
Education / Experience Qualifications
- Bachelor’s degree, ideally in a scientific discipline; equivalent experience. At least 3 years of demonstrated data management knowledge, may also be considered.
- At least 2 years of demonstrated knowledge and use of data management techniques.
- Up to 1 year of industry experience in pharmaceutical, medical device, combination product/device, in vitro diagnostics, research and development, clinical research, quality systems, regulatory, or comparable environments.
- Master’s degree in data science, data analytics, Computer Science, Computer Engineering, Statistics, Business Administration, or a related field, with at least 2 years of demonstrated data management experience.
Competencies
- Strong understanding of data management techniques, EDC programming, edit checks, queries, and related tools.
- Adaptable, resourceful, and comfortable working independently while contributing to shared team goals.
- Curious learner with strong problem-solving skills and a solutions-oriented mindset.
- Strong organizational skills with the ability to manage multiple priorities and timelines.
- Clear, concise communicator who seeks and provides meaningful feedback.
- Understanding of clinical trial regulatory requirements for IVD and medical device studies.
- Working knowledge of ICH, GCP, and FDA regulatory requirements.
- Effective interpersonal, collaboration, and presentation skills.
- Ability to assess data integrity risks and provide thoughtful data management input.
- Able to make thoughtful decisions in a fast-paced environment.
- Comfortable adapting to evolving priorities, timelines, and study needs.
Work Environment / Physical Demands
- Remote home-based office position with working conditions suitable for focused, effective work.
- Availability consistent with established business practices; occasional additional time may be needed to meet critical deadlines.
- Occasional travel may be required by conventional means, including aircraft or motor vehicle, and may include trips of 5 or more consecutive days.
Featured Benefits:
- Medical insurance
- Vision insurance
- Dental insurance
- 401K Plan and company match
If you do not meet every listed qualification but believe your experience and strengths align with this role, we encourage you to apply. We value diverse perspectives, transferable skills, and a willingness to learn.
We are proud to be an equal opportunity employer. We select and employ candidates only in accordance with their merits, qualifications, and abilities to perform the duties of the job regardless of gender, marital status, race, religion, color, age, disability, sexual orientation, military or veteran status. If you require an accommodation as part of the application and/or interview process, please contact [email protected].