On-Site Study Database Manager — Clinical Data & Compliance

ACL Digital; Maple Grove (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

ACL Digital in Maple Grove, MN seeks a Study Database Manager-Data Management for on-site work in medical devices. You will manage clinical databases, validate deliverables, and ensure regulatory compliance through cross-functional collaboration.

Responsibilities include CRF design input, database setup with edit checks, and adherence to data standards. Candidates should have 5+ years in the medical device/pharma space and 2+ years with a CDMS.

Qualifications

• Minimum 5 years' experience working for a Medical Device, Pharmaceutical, or Biopharmaceutical Company.
• Minimum 2 years' experience using a clinical data management system performing clinical study database setup, including edit check programming.

Responsibilities

• Oversee clinical database development and maintenance ensuring quality and regulatory compliance.
• Review CRF design and study protocol input through cross-functional collaboration.
• Lead setup of clinical study databases in a clinical data management system, including edit checks.
• Define and verify database specifications and Edit Check specifications.
• Follow SDLC to design, configure, test and document databases.
• Collaborate with development staff to ensure data integrity and consistency.
• Escalate live errors and service problems to minimize downtime and resolve issues.
• Provide high-level design recommendations for data management solutions.
• Review clinical research protocols, reports, and statistical analysis plans.

Skills

Medical Device industry experience

Clinical data management system

Edit check programming

CRF design review

Tools

Oracle Clinical

Oracle Clinical Inform

Oracle Clinical One

Job description

ACL Digital in Maple Grove, MN seeks a Study Database Manager-Data Management for on-site work in medical devices. You will manage clinical databases, validate deliverables, and ensure regulatory compliance through cross-functional collaboration.

Responsibilities include CRF design input, database setup with edit checks, and adherence to data standards. Candidates should have 5+ years in the medical device/pharma space and 2+ years with a CDMS.