Clinical Data Manager

4 C Medical Technologies•Maple Grove, MN

1d•$100,000 - $120,000

About The Position

The Clinical Data Manager supports execution of clinical data management activities for investigational structural heart device studies. Working closely with the Principal Data Manager and cross-functional partners, the role helps ensure clinical trial data is accurate, complete, reliable, and ready for study milestones and regulatory submissions. The position owns day-to-day data management activities across the clinical trial lifecycle, from study start-up and database development through data cleaning, database lock, and regulatory submission. It also contributes to the quality and integrity of clinical evidence supporting development of the company’s transcatheter mitral valve replacement technology.

Requirements

Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related technical field.
3–6 years of experience in clinical data management, preferably within the medical device industry.
Experience supporting clinical trials across the data management lifecycle, including database development, data cleaning, query management, and database lock.
Working proficiency with Electronic Data Capture (EDC) systems, such as Medidata Rave or CatchTrials, and familiarity with CRF/eCRF design.
Knowledge of clinical data validation, reconciliation, quality control, and data integrity requirements.
Familiarity with clinical research regulations and standards, including ICH-GCP, FDA 21 CFR Part 11, and ISO 14155.
Strong analytical, organizational, and problem-solving skills, with excellent attention to detail.
Effective written and verbal communication skills and ability to collaborate across functional teams.
Ability to manage multiple priorities, meet deadlines, work independently, and recognize when issues require escalation.

Nice To Haves

Experience supporting investigational medical device trials, particularly structural heart or other Class III devices.
Familiarity with IDE, PMA, 510(k), CE Mark, or post-market clinical study requirements.
Knowledge of CDISC, CDASH, and SDTM standards and their application to clinical trial data.
Familiarity with SQL, SAS, or other clinical data reporting and analysis tools.
Experience configuring, maintaining, testing, or troubleshooting clinical databases and electronic data capture systems.
Experience coordinating data deliverables, resolving discrepancies, and maintaining data quality with clinical research sites, CROs, and external vendors.
Familiarity with data protection requirements, including GDPR where applicable.
Takes initiative, follows through on commitments, and proactively addresses data quality issues.
Comfort managing competing priorities in a fast-paced environment while identifying opportunities to improve processes and outcomes.
Clinical data management or industry certifications, such as CCDM or CDISC-related credentials.

Responsibilities

Manage day-to-day clinical data activities for assigned studies in alignment with protocols, Data Management Plans, regulatory requirements, and company procedures.
Support development and maintenance of clinical databases, electronic Case Report Forms (eCRFs), data management documentation, and related guidelines.
Perform data cleaning, query management, data validation, reconciliation, and quality control.
Monitor data quality, outstanding queries, discrepancies, and study timelines; communicate risks and escalate issues as needed.
Support database lock preparation and execution, including data cleaning, reconciliation, documentation review, and resolution of outstanding issues.
Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Affairs, clinical research sites, and external vendors to support timely data collection, review, and delivery.
Support electronic data capture (EDC) system activities, including user acceptance testing, troubleshooting, and coordination with system vendors.
Prepare and review clinical data listings, reports, data transfers, and other deliverables supporting clinical study reports and regulatory submissions.
Maintain accurate, traceable, audit-ready documentation and support internal audits, regulatory inspections, and quality reviews.
Support compliance with applicable FDA regulations, 21 CFR Part 11, ICH-GCP, ISO 14155, EU MDR, and relevant clinical data standards.
Identify opportunities to improve data management processes, strengthen data quality, and promote consistency across clinical studies.