Clinical Data Manager

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

We are partnering with a cardiovascular medical device start-up as they add 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, 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.