Study Database Manager – Data Management

ACL Digital; Maple Grove (MN); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Medical Device industry experience

Clinical data management system

Edit check programming

CRF design review

Herramientas

Oracle Clinical

Oracle Clinical Inform

Oracle Clinical One

Descripción del empleo

Role: Study Database Manager-Data Management - Medical Devices (on-site)

Location: Maple Grove, MN (Open to Relocate)

Mode: On-site (5days)

Experience: Minimum 5 years

Responsibilities

• Study Database Manager-Data Management - Medical Devices (on-site)
• The Study Database Manager is responsible for clinical database development and maintenance; validation of deliverables; adherence to processes, systems, standards, and best practices with attention to quality and regulatory compliance.
• Through cross-functional collaboration, the Study Database Manager will review Case Report Form (CRF) design, study protocol review, and provide input.
• They will review database specification functional requirements and Edit Check specifications and provide feedback.
• They will lead and/or participate in set-up of clinical study databases in a clinical data management system, including programming of edit checks.
• Ensure that standards and conventions are followed and data structure is fit for purpose for downstream reporting.
• Follow the company software development lifecycle to design, code, configure, test, debug, and document clinical study databases using a clinical data management system.
• Collaborate with other development staff to achieve quality and consistency.
• Problem solver and decision maker with the ability to handle multiple tasks simultaneously.
• Actively participates in the escalation of live errors and service problems to limit downtime and resolve problems.
• Team player who develops high-level design for solutions.
• Debugs, troubleshoots, and isolates clinical data management systems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development.
• Ability to work creatively and productively with minimal supervision.
• Participate in the review of clinical research protocols, reports, and statistical analysis plans.

Qualifications

• Required 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.

Required Skills

• 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.

Preferred Skills

• Preferred Qualifications Prior experience in study-specific database configuration utilizing Oracle Clinical, Oracle Clinical Inform, or Oracle Clinical One or other data management systems.
• Experience in adherence to FDA 21 CFR Part 11 and Guidance for Good Clinical Practices (GCP) data-handling procedures and guidelines.