Position Details

Type Full-Time

Experience mid

Exp. Years 5+ years

Education Not specified

Category System Administration

About this role

This role involves leading local study teams in clinical research, ensuring compliance with international guidelines, managing site qualification and monitoring, and coordinating regulatory submissions.

Key Responsibilities

Lead local study teams
Manage site qualification
Coordinate regulatory submissions
Oversee study start-up and closure
Ensure compliance with ICH-GCP

Technical Overview

Focus on clinical trial operations, ICH-GCP compliance, site qualification, CTMS systems, and regulatory documentation.

Ideal Candidate

The ideal candidate is a mid-level clinical research professional with experience leading local study teams, managing site qualification and monitoring, and ensuring compliance with ICH-GCP guidelines. They should be skilled in regulatory submissions and study coordination.

Must-Have Skills

Experience leading local study teamsKnowledge of ICH-GCP guidelinesSite qualification and monitoring experienceRegulatory submission experienceBudget and documentation management

Nice-to-Have Skills

Experience with CTMS systemsExperience in clinical research operationsKnowledge of local regulations

Tools & Platforms

CTMSRegulatory Submission Platforms

Required Skills

clinical trial managementICH-GCPsite qualificationregulatory submissionsbudget managementsite monitoringstudy coordinationCTMSregulatory affairsdocumentation management

Hard Skills

Clinical Trial ManagementICH-GCPSite QualificationRegulatory SubmissionsBudget ManagementSite MonitoringStudy CoordinationCTMSRegulatory AffairsDocumentation Management

Soft Skills

LeadershipOrganizationCommunicationProblem-solvingAttention to detailTeam coordination

Industry & Role

Industry Pharmaceuticals & Clinical Research

Job Function Clinical research study management and site oversight

Role Subtype System Administration

Tech Domains Active Directory, Microsoft 365, Regulatory Affairs, Clinical Trial Management

Keywords for Your Resume

clinical trial managementICH-GCPsite qualificationregulatory submissionsbudget managementsite monitoringstudy coordinationCTMSregulatory affairsdocumentation managementclinical researchstudy deliverylocal study teamsite qualification visitsstudy start-upstudy closure

Deal Breakers

Lack of experience with clinical trial management, No knowledge of ICH-GCP, No site monitoring experience, Lack of regulatory submission experience

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