Apply on Employer Site

Medical Engineering Consultants (MEC) · 2 months ago

Clinical Data Specialist

Arden Hills, Minnesota

Full-time

Onsite

Entry, Mid Level

2+ years exp

Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise to enhance their productivity. The Clinical Data Specialist is responsible for ensuring the quality and integrity of clinical data through collaboration with various teams and developing necessary documentation and tools.

ConsultingMedical DevicePharmaceuticalTraining

No H1B

Responsibilities

Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan

Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP)

Provide subject matter expertise to project team members during all phases of project life cycle

Provides accurate and timely clinical data to internal and external customers upon request

Develop, test, and maintain data management systems

Provide subject matter expertise prior, during and post internal and external audits and inspections

Maintain compliance with corporate, core and study-specific learning requirements

Qualification

Clinical data reviewData management documentationClinical Practices (GCP)Medical device backgroundProgramming knowledgeCollaboration skillsProblem-solving skills