Clinical Data Manager — Cardio Medical Device Startup

Custom Search Inc.; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Custom Search Inc. is partnering with a cardiovascular medical device start-up to add a Clinical Data Manager to support clinical trials for a Class III investigational device.

You'll work closely with the Principal Data Manager and cross-functional teams, supporting studies from start-up and database development through data cleaning, database lock, and regulatory submissions. The role offers hands-on ownership and an opportunity to shape processes as the company grows.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3–6 years of clinical data management experience.
• Hands-on with eCRF design, data cleaning, and database lock.
• Experience with FDA, ICH-GCP, 21 CFR Part 11, ISO 14155.
• Experience with Class III device trials or regulatory submissions is desirable.

Responsibilities

• Manage day-to-day clinical data management activities with data accuracy and compliance.
• Support database development, including eCRF design and DMPs.
• Oversee data cleaning, queries, validation, reconciliation, and QC.
• Monitor data quality and timelines, proactively resolve issues.
• Support database lock and data preparation for regulatory submissions.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, sites, CROs, vendors.
• Support EDC activities including UAT, troubleshooting, and maintenance.
• Maintain audit-ready documentation and improve data management processes.

Skills

Data management

Regulatory knowledge

Attention to detail

Project coordination

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

Medidata Rave

CatchTrials

SQL

SAS

Job description

Custom Search Inc. is partnering with a cardiovascular medical device start-up to add a Clinical Data Manager to support clinical trials for a Class III investigational device.

You'll work closely with the Principal Data Manager and cross-functional teams, supporting studies from start-up and database development through data cleaning, database lock, and regulatory submissions. The role offers hands-on ownership and an opportunity to shape processes as the company grows.