Clinical Data Manager

Clinical Data Manager Opportunity

We are partnering with an innovative medical device start-up, adding a Clinical Data Manager to support clinical trials for a Class III investigational device.

This is a great opportunity for someone who enjoys hands-on work, takes ownership of their work, and makes an impact in a growing organization. You'll work closely with the Principal Data Manager and cross-functional teams, supporting clinical studies from start-up and database development through data cleaning, database lock, and regulatory submissions. Unlike larger organizations, you'll have the opportunity to wear multiple hats, contribute ideas, and help shape processes as the company grows.

Your Role With The Company:

• Manage day-to-day clinical data management activities, ensuring data accuracy, integrity, and compliance with study protocols and regulatory requirements.

• Support clinical database development, including eCRF design, Data Management Plans, and related documentation.

• Oversee data cleaning, query management, validation, reconciliation, and quality control.

• Monitor data quality, study timelines, and outstanding queries, proactively resolving issues.

• Support database lock activities and preparation of clinical data for regulatory submissions.

• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, clinical sites, CROs, and external vendors.

• Support EDC system activities, including user acceptance testing (UAT), troubleshooting, and database maintenance.

• Maintain audit-ready documentation and identify opportunities to improve data management processes.

Desired Profile:

• Bachelor's degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related field.

• 3–6 years of clinical data management experience, preferably within the medical device industry.

• Hands-on experience with database development, eCRF design, data cleaning, query management, and database lock.

• Experience with EDC systems such as Medidata Rave, CatchTrials, or similar platforms.

• Familiarity with FDA regulations, ICH-GCP, 21 CFR Part 11, and ISO 14155.

• Experience supporting Class III medical device trials, IDE/PMA studies, or regulatory submissions is highly desirable.

• Knowledge of CDISC, CDASH, SDTM, SQL, SAS, or other clinical data reporting tools is a plus.

• Strong attention to detail, organizational skills, and the ability to manage multiple priorities.

• A proactive, collaborative problem-solver who enjoys working in a fast-paced start-up environment.