Senior Clinical Research Associate, Site Manager
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Job Description
Senior Clinical Research Associate overseeing clinical trials in compliance with regulations. Collaborating with study centres and ensuring quality while managing study documentation and data validation.
Responsibilities:
- Standard CRA activities depending on the project and in accordance with ICH-GCP, applicable SOPs, and national and international regulatory requirements
- Support in organizing the study at investigational sites and providing support to principal investigators
- Preparation, conduct and follow-up of initiation, monitoring and close-out visits (SIV, MV, COV) — on-site or remote/online, including report writing
- Querying the study status at investigational sites (according to a predefined guide) and documenting progress
- Validation of investigator-collected study data (source data verification, SDV)
- Checking investigational sites for compliance with applicable guidelines and laws (ICH-GCP, SOPs, AMG/MPG/MDR)
- Coordination with data management and project management
- Creation of queries and oversight of the query process
- Training investigators and site coordinators on EDC software
- Conducting feasibility assessments for new projects with investigational sites
- Support in preparing study documents, including distribution and tracking
- Preparation of submission documents for regulatory authorities and ethics committees
- Support during audits/inspections at investigational sites
- Optional lead/oversight responsibilities: lead site management in national and international projects, e.g.: training of the CRA team, quality assurance through review of monitoring reports, planning and coordination of visits and regular site contacts, sponsor communication regarding monitoring/site management, contract management, feasibility/site selection, preparation of monitoring plans
Requirements:
- Degree in natural sciences or life sciences
- Study nurse qualification or equivalent
- Professional experience (>3 years) in conducting GCP-regulated clinical trials within industry (e.g., CRO, pharmaceutical or biotech) as Lead CRA required
- Independent and proactive working style in planning and implementation
- High interpersonal skills and strong team orientation
- Excellent communication and organizational skills
- Excellent German language skills
- Very good English skills (spoken and written)
- Good knowledge of Office applications
- Willingness to travel and flexibility
Benefits:
- A fair compensation package
- Permanent employment
- 30 days of annual leave (based on a 5-day week)
- Flexible working hours
- Overtime compensation / time off in lieu
- Home-based contract (home office combined with regular travel)
- Company bike (bike leasing)
- Employer contributions to capital-building savings (VWL)
- Health promotion allowance
- Regular company events and team-building activities
- Learning and development options (e.g., Babbel app)
- Monthly #WinAHappening
- Free e-car charging stations
- Complimentary fruit basket and beverage allowance
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