Clinical Data Manager - Medical Device

Planet Pharma; Minnesota; Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Planet Pharma, a leading Medical Device company, is seeking an experienced Study Database Manager (EDC) to join our on-site Minneapolis team.

You will develop and maintain clinical databases, validate deliverables, review CRF designs, and collaborate across cross-functional teams to ensure quality and regulatory compliance.

The role requires 5+ years in medical device/pharma, expertise with Oracle Clinical or similar systems, and strict adherence to FDA 21 CFR Part 11 and GCP.

Formación

• Minimum 5 years’ experience in Medical Device/Pharmaceutical/Biopharmaceutical companies.
• Minimum 2 years’ experience using a clinical data management system for study database setup and edit check programming.
• Experience with Oracle Clinical/Inform/OCI cloud or similar systems is preferred.
• Knowledge of FDA 21 CFR Part 11 and GCP data-handling procedures is desired.

Responsabilidades

• Develop and maintain study databases; validate deliverables.
• Review CRF design and study protocol; provide input.
• Lead/set up databases in a clinical data management system with edit checks.
• Ensure data structures support downstream reporting and regulatory standards.
• Follow SDLC to design, code, configure, test, and document databases.
• Collaborate with development staff and escalate live errors to limit downtime.

Conocimientos

Clinical data management

Regulatory compliance

Cross-functional collaboration

Problem solving

Database setup

Herramientas

Oracle Clinical

Oracle Clinical Inform

Oracle Life Sciences Cloud

Descripción del empleo

***Please Note: We are only accepting local candidates in the Minneapolis area - this is a fully onsite role***

Our client, a leading Medical Device company, is seeking an EDC Database builder for their growing team. See below for details!

Responsibilities:

• 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 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 that 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.

Requirements:

• 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 Qualifications:

• Prior experience in study specific database configuration utilizing Oracle Clinical, Oracle Clinical Inform, or Oracle Life Sciences Cloud 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.