Support GCP compliance for clinical operations to ensure regulatory adherence.
Assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity.

Requirements

Bachelor’s degree in a scientific or related discipline, or 5 years of equivalent experience.
3-5 years of eTMF experience, including study start-up, maintenance, and quality reviews.
3+ years of experience in pharmaceutical industry roles related to clinical trials (e.g., clinical operations, project management).
Experience in quality assurance or quality management activities. GCP Specialist
Experience with GCP vendor and site audits preferred.
Ability to manage projects and tasks in a fast-paced environment.
Analytical and critical thinking skills for quality review decision-making.
Knowledge of pharmaceutical industry standards, including ICH/GCP guidelines.
Experience with BIMO inspections preferred; EMA/MHRA/PDMA experience a plus.
Communication skills, both verbal and written.
Leadership and problem-solving skills.
Ability to translate strategy into operations and manage multiple priorities.
Ability to work independently with limited supervision.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

eTMFquality assurancequality managementGCP complianceclinical trial integrityproject managementanalytical skillscritical thinkingBIMO inspectionsICH/GCP guidelines

Soft Skills

communication skillsleadershipproblem-solvingability to manage multiple prioritiesindependent workcollaborationfast-paced environment managementdecision-making

Certifications

GCP Specialist