Pivotal IDE Trial | Cardiovascular Device | Start-Up Environment

Our start-up client is hiring a Senior Clinical Data Manager to lead all data management activities for a pivotal IDE trial.

This is not a maintenance role.
You will own the data strategy from study startup through database lock — ensuring submission-ready quality for FDA and global regulatory authorities.

Your role with the company:

• Lead the full data lifecycle for the IDE trial

• Oversee data cleaning, query management, reconciliation, and lock

• Ensure submission-ready datasets for PMA, IDE, and 510(k) filings

• Partner closely with Regulatory to build defensible data packages

• Manage EDC systems (Rave / CatchTrials) and oversee UAT

• Mentor one Clinical Data Manager (programming support in place)

• Proactively identify trends and risks to protect data integrity

This role is a step up — you’ll shape how the data management function operates, not just execute tasks.

Desired Profile:

• 5–10 years in device clinical data management

• 3–5 years in senior/lead capacity

• IDE/PMA submission experience

• Strong FDA knowledge (OUS exposure a plus)

• Cardiovascular or structural heart preferred

Work Model

Remote flexibility with monthly travel to Minnesota (more frequent initially).

If you want ownership, visibility, and real impact on a pivotal submission, this is a meaningful seat at the table.