Senior Clinical Research Associate II

This is a fully remote position, open to applicants in Germany.

📋 Description

• Take charge of and oversee assigned clinical trial sites throughout the complete study lifecycle—from initiation to close-out.

• Ensure that clinical trials are executed in compliance with the study protocol, Monitoring Plan, regulatory standards, and internal quality benchmarks.

• Assume responsibility for the timely achievement of study milestones and maintain high quality standards at the site level.

• Act as the main point of contact for clinical trial sites during the study's progression.

• Foster and sustain trusted relationships with investigators and study personnel.

• Collaborate closely with Site Care Partners, Study Leads, and global study teams.

• Assist in recruitment and site activation efforts to enhance patient enrollment.

• Perform onsite, remote, and electronic monitoring, which includes Site Initiation Visits, routine monitoring visits, and Close-Out Visits.

• Proactively identify, evaluate, and address study and quality risks.

• Develop and monitor Corrective and Preventive Actions (CAPAs).

• Ensure accurate documentation within study systems and Trial Master Files.

• Monitor Adverse Events (AEs) and Serious Adverse Events (SAEs) while collaborating with Safety functions.

• Guarantee compliance with regulatory obligations, data privacy laws, and Good Clinical Practice (GCP) standards.

• Assist with audits, inspections, and quality initiatives.

• Mentor and guide Clinical Research Associates and Senior Clinical Research Associates I.

• Provide subject-matter expertise for CRA-related processes.

• Contribute to or lead regional and global process improvement efforts.

⛳️ Requirements

• A university degree in Life Sciences or a comparable field, such as nursing, pharmacy, medicine, or a related discipline.

• A minimum of 5 years of pertinent experience in clinical trial monitoring.

• Experience in conducting global clinical trials.

• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical research methodologies.

• Strong analytical and problem-solving capabilities.

• A solid orientation towards quality and compliance.

• Ability to operate effectively and influence within a complex matrix organization.

• Exceptional communication and presentation skills.

• Experience in providing subject-matter support and mentoring colleagues.

• Proficiency in both German and English, written and spoken.

• Experience in oncology, vaccines, internal medicine, or infectious diseases is a plus.

🏝️ Benefits

• Equal treatment and equal opportunities throughout the entire application process.

• Reasonable accommodations to support applications, interviews, and future career development for candidates with disabilities.