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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research data management, ensuring compliance with regulatory guidelines and Good Clinical Practice (GCP) standards. Proficient in electronic data capture systems and skilled in generating reports and presentations for stakeholders.
Highest-signal resume keywords
Clinical Research ExperienceData Management SkillsKnowledge of Good Clinical Practice (GCP)Proficiency in MS Office (Word, Excel)Bilingual in German and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data MonitoringData Quality AssuranceData Discrepancy ResolutionElectronic Data Capture SystemsReport GenerationData Management Plans ReviewProcess OptimizationSOP RevisionMedical Data CollectionRegulatory Compliance
Soft Skills
Attention to DetailAnalytical SkillsExcellent CommunicationInterpersonal SkillsTeam Collaboration
Certifications & Qualifications
Training in Healthcare SectorCertification as a Monitor
Industry Keywords
Clinical ResearchRegulatory GuidelinesPharmacovigilanceInterdisciplinary TeamsQuality Standards
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Monitor and review clinical research data for accuracy, completeness, plausibility and consistency
- Ensure compliance with study protocols and regulatory guidelines
- Identify and resolve data discrepancies or issues in a timely manner
- Verifying the accuracy of all rules within the data capture system by entering test data
- Communicate with study sites and data managers to address data quality concerns
- Review data management plans
- Assist in the development and implementation of data quality assurance processes
- Support in generating reports and presentations on data monitoring activities for internal and external stakeholders
- Resource planning and co-ordination of all monitors in consultation with head of project management
- Manage site administration activities and maintain records
- Work in interdisciplinary teams with (but not limited to) project management, data management, data operations, medical advisor, pharmacovigilance
- Support in training monitors (in conjunction with PM, DM and Medical Advisor)
- Support in setting up and testing electronic questionnaires /documentation forms
- Support in pharmacovigilance related activities
- Management of participants in medical data collection surveys
- Assisting adherence to quality standards, project requirements, and compliance regulations throughout the project lifecycle
- Support in process optimization and revision of SOPs and work instructions
Requirements
What you’ll need- Completed training in the healthcare sector; further certification as a monitor or similar is desirable
- Experience working in clinical research, data management, or related field
- Strong attention to detail and analytical skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Knowledge of electronic data capture systems
- Very good knowledge of MS Office, especially in Word and Excel
- Knowledge of regulatory guidelines and Good Clinical Practice (GCP) standards
- Team spirit, flexibility and excellent communication required
- Very good written and spoken German and English skills
Benefits
Comp & perks- Health insurance
- Professional development opportunities
- Flexible working hours