Senior Clinical Research Associate – homebased

🕒 March 17

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Alcedis - a HUMA company

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1992

🧬 Biotechnology

💊 Pharmaceuticals

☁️ SaaS

Biotechnology • Pharmaceuticals • SaaS

Alcedis - a HUMA company is a global contract research organization (CRO) that organizes and executes data-driven clinical studies and advances digital clinical research through proprietary technologies. It combines end-to-end clinical services — including project management, data management, monitoring, regulatory affairs, biostatistics, medical writing and pharmacovigilance — with software platforms (adaptive eCRFs, mobile apps, integrations) and AI/data-science capabilities to support biotech and pharmaceutical development from early-phase trials through regulatory approval and real-world evidence. Alcedis emphasizes technology-first, SaaS-style platforms to improve efficiency, data quality and patient-centric outcomes.

📋 Description

• Support with study organization at investigational sites • Support and oversight of site investigators • Preparation, conduct and follow-up of site initiation, monitoring and close-out visits (SIV, MV, COV) • Querying the study status at sites and documenting findings • Validation of study data collected by site investigators • Checking sites for compliance with applicable guidelines and laws • Coordination with Data Management and Project Management • Creation of queries and oversight of the query process • Training investigators and site staff on EDC software • Conducting feasibility assessments • Support in preparing study documentation • Preparation of submission documents for regulatory authorities and ethics committees • Support during audits/inspections at study sites • Optional: Lead site management in national and international projects

🎯 Requirements

• Degree in natural sciences or life sciences or comparable qualification • Professional experience (>3 years) in conducting GCP-regulated clinical trials within industry (e.g., CRO, pharmaceutical or biotech) as a Lead CRA • Independent and proactive working style • Strong interpersonal skills and pronounced 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

• 30 days of vacation (based on a 5-day workweek) • Flexible working hours • Overtime compensation / time off in lieu • Home-based contract (remote work combined with regular travel) • Company bike (bike leasing) • Employer contributions to capital-building savings (VWL) • Additional salary allowance for health promotion • Regular company events and team-building activities • Learning and development options (e.g., Babbel app) • Free electric vehicle charging stations • Fruit basket and free beverage allowance