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Clinical Research Associate – Clinical Monitor – Site Manager
Alcedis - a HUMA company. Support the organization and conduct of clinical trials at investigational sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting GCP-compliant clinical trials, including site management, data verification, and regulatory submissions. Proficient in training stakeholders and maintaining compliance with applicable guidelines while effectively communicating with investigators and study staff.
Highest-signal resume keywords
GCP-Compliant Clinical TrialsStudy Data VerificationRegulatory SubmissionsElectronic Data Capture (EDC) SoftwareStakeholder Coordination
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementFeasibility AssessmentsSource Data VerificationStudy Document PreparationMonitoring and Close-Out Visits
Soft Skills
Reliable PlanningOrganizational SkillsProfessional CommunicationProblem-SolvingProactive Approach
Tools & Technologies
Electronic Data Capture (EDC) SoftwareMicrosoft Office ApplicationsDatabases
Certifications & Qualifications
Degree in Natural SciencesDegree in Life SciencesQualification as a Study Nurse
Industry Keywords
Clinical TrialsInvestigational SitesCROPharmaceuticalBiotech
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support the organization and conduct of clinical trials at investigational sites
- Provide support to investigators
- Request and document study status updates
- Prepare, conduct, and follow up on initiation, monitoring, and close-out visits, either on-site or remotely
- Prepare visit reports
- Conduct feasibility assessments for new projects
- Validate study data collected by investigators through source data verification
- Verify that investigational sites comply with applicable guidelines and legal requirements
- Support audits and inspections at investigational sites
- Create and monitor queries related to study data
- Coordinate with relevant stakeholders and work closely with Data Management and Project Management
- Train investigators and study coordinators on the use of EDC software
- Serve as the interface between investigational sites, Project Management, and other involved teams
- Support the preparation, distribution, and tracking of study documents
- Prepare documents for submissions to regulatory authorities and ethics committees
- Regular on-site work at investigational sites, with approximately 30–40% travel
- Independently manage the Southern Germany region
Requirements
What you’ll need- Degree in natural sciences or life sciences, qualification as a Study Nurse, or comparable qualification
- Initial professional experience conducting GCP-compliant clinical trials in an industry setting (e.g., CRO, pharmaceutical, or biotech) is essential
- Independent, forward-thinking, and conscientious approach to work
- Reliable planning and organizational skills, combined with a careful and precise working style
- Ability to maintain an overview even in complex situations and find pragmatic solutions
- Confident and professional communication, including when addressing critical topics
- Ability to clearly communicate requirements and build trusting working relationships with investigators and study staff
- Initiative and proactive approach to work
- Excellent German and very good written and spoken English skills
- Confident handling of electronic data, databases, and standard Microsoft Office applications
- Flexibility and willingness to travel approximately 30–40% of the time
Benefits
Comp & perks- 30 days of annual leave based on a five-day working week
- Flexible working hours
- Time off in lieu for overtime
- Home-based contract combining remote work with regular travel
- Company bicycle leasing
- Employer-funded benefits (VWL)
- Benefits card as a salary extra for health and wellness initiatives
- Regular company events
- Learning and professional development opportunities
- Free electric vehicle charging stations at the company’s Gießen headquarters
- Meaningful work in the field of clinical research
- Pleasant working atmosphere and strong team spirit
- Modern and open corporate culture with flat hierarchies and no dress code
- Future-oriented and secure working environment
- Long-term, trusting employee relationships
- Fresh fruit basket
- Free beverages