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Clinical Research Associate, Clinical Monitor, Site Manager
Alcedis - a HUMA company. Support the organization and conduct of clinical trials at investigative sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with GCP guidelines, and effectively communicating with investigative sites and project teams. Proficient in data management and regulatory submissions, with a strong focus on organization and problem-solving.
Highest-signal resume keywords
GCP-Compliant Clinical TrialsElectronic Data Capture (EDC) SoftwareRegulatory SubmissionsStudy Data VerificationInvestigator Training
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 ManagementData VerificationFeasibility AssessmentsReport PreparationStudy Documentation
Soft Skills
Professional CommunicationPlanning and OrganizationProblem-SolvingProactive Working StyleFlexibility
Tools & Technologies
Microsoft OfficeDatabasesEDC Software
Industry Keywords
Clinical TrialsInvestigative SitesCROPharmaceuticalBiotech
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support the organization and conduct of clinical trials at investigative sites
- Manage relationships with investigators and obtain and document study status updates
- Prepare, conduct, and follow up on site initiation, monitoring, and close-out visits—on-site or remotely—including report preparation
- Conduct feasibility assessments for new projects
- Validate study data as part of source data verification
- Verify that investigative sites comply with applicable guidelines and legal requirements
- Support audits and inspections at investigative sites
- Raise study data queries, coordinate them with relevant contacts, and monitor the query process
- Work closely with Data Management and Project Management
- Train investigators and study coordinators on the use of EDC software
- Serve as the liaison between investigative sites, Project Management, and other involved teams
- Prepare study documents, including shipment and tracking, or support these activities
- Prepare documentation for submissions to regulatory authorities and ethics committees
- Independently manage the Southern Germany region
- Visit investigative sites on a regular basis; travel approximately 30–40%
Requirements
What you’ll need- University degree in natural sciences or life sciences, or qualification as a Study Nurse or comparable qualification
- At least 2 years of professional experience conducting GCP-compliant clinical trials in an industry setting (e.g., CRO, pharmaceutical, or biotech); mandatory requirement
- Excellent German language skills
- Very good written and spoken English
- Proficiency with electronic data, databases, and standard Microsoft Office applications
- Flexibility and willingness to travel approximately 30–40% of the time
- Independent, forward-thinking, and conscientious working style
- Reliable planning and organization skills, with a careful and precise approach
- Ability to maintain an overview of complex matters and find pragmatic solutions
- Confident and professional communication, including when addressing critical issues
- Initiative and a proactive working style
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 office combined with regular travel (home-based contract)
- Company bicycle leasing
- Employer contributions to capital-forming benefits
- Benefits card as a salary extra to support health and well-being
- Regular company events
- Learning and professional development opportunities
- Free electric vehicle charging stations at the company headquarters in Giessen
- 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, trust-based employee relationships
- Fruit basket and complimentary beverages