Senior Clinical Research Associate, Site Manager

🕒 March 24

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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

• 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