Senior Clinical Research Associate

Alira Health Group; München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global healthcare consultancy is seeking a Senior Clinical Research Associate to conduct site monitoring for clinical trials remotely from Munich. This role involves ensuring compliance, guiding the CRA team, and managing study budgets. Applicants should hold a relevant degree and have clinical monitoring experience. Join a vibrant team dedicated to innovating healthcare and life sciences.

Leistungen

Professional development

Global travel

Flexible work programs

Qualifikationen

• Minimum 2 years of clinical monitoring experience.
• Ability to manage monitoring activities independently.
• Fluent in local language and English.

Aufgaben

• Conduct site monitoring responsibilities for clinical trials.
• Ensure compliance and quality during trials.
• Manage study budgets and prepare monitoring visit reports.

Kenntnisse

Detail-oriented

Strong organizational skills

Analytical skills

Negotiation skills

Fluency in English

Ausbildung

BS in Biology, Biotechnology, Life Sciences, or Pharmacy

Tools

Clinical trial systems

Electronic data capture

Jobbeschreibung

Senior Clinical Research Associate page is loaded

Senior Clinical Research Associate

Apply remote type: Remote | locations: Munich-Remote | time type: Full time | posted on: Posted Yesterday | job requisition id: JR000421

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. We value all contributions and new ideas, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

Job Description Summary

Job Description

Role

The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials, providing oversight, leadership, and guidance to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Key Responsibilities

• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed.
• Ensure appropriate and timely investigator site visits.
• Coordinate with cross-functional departments to facilitate negotiation and issue resolution related to clinical trial monitoring.
• Assist in developing study-specific Monitoring Plans and training presentations.
• Assist in setting up and collecting site-specific ethics documents and site contract negotiations.
• Provide monthly billing information to the finance team.
• Manage study budgets and act as a referent for the sponsor for monitoring stand-alone projects.
• Perform qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation.
• Prepare accurate and timely monitoring visit reports.
• Ensure data integrity through meticulous source document review and verification.
• Perform quality control and verification of documents at sites for eTMF/TMF.
• Conduct investigational product accountability.
• Review site regulatory binders for required documents.
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual, and respond to sponsor requests.
• Comply with ICH GCP guidelines, FDA regulations, and SOPs.
• Participate in internal, client/sponsor, scientific, and other meetings.
• Facilitate adverse event reporting and reconcile SAE reports.
• Work with in-house CRAs/CTC and data management to resolve data queries.
• Identify site issues proactively and develop solutions.
• Prepare for audits at study sites as needed.
• Collaborate with other CRAs to maintain consistency and team collaboration.
• Assist in CRA new hire training and onboarding.
• Mentor CRAs.
• Contribute to the development and maintenance of the Clinical Trial Management System (CTMS).
• Manage conflicting priorities to meet commitments.
• Perform additional duties as assigned.

Desired Qualifications & Experience

• US: BS/BA in life sciences or related field; 3 years in pharma/biotech/CRO, with 2 years in clinical monitoring and 1 year in management.
• EU: Minimum 2 years of clinical monitoring experience and ability to manage monitoring activities independently.

Technical Skills & Soft Skills

• Detail-oriented with a focus on quality.
• Strong organizational skills; ability to multitask in a fast-paced environment.
• Ability to manage priorities, organize time, and solve problems.
• Strong analytical, negotiation, leadership, and team skills.
• Ability to travel and manage stress effectively.
• Professional, trustworthy, disciplined.
• Problem-solving skills for unstructured challenges.
• US: Fluent in English; EU: Fluent in local language and English.
• Excellent communication and interpersonal skills.
• Proficient with clinical trial systems and electronic data capture.
• Self-starter with collaborative mindset.
• Knowledge of clinical research, ICH GCP, and local regulations.
• Ability to build positive relationships with sponsors, sites, and teams.
• US: Authorization to work in the US; EU: Certified Monitor in Italy or relevant qualifications.

Languages: English

Education: BS in Biology, Biotechnology, Life Sciences, or Pharmacy

Contract Type: Regular

About Us

Alira Health is a global advisory firm providing consulting, research, and clinical development services, dedicated to humanizing healthcare and life sciences through innovative technologies and expert guidance. We support Pharma, Biotech, and MedTech clients across their solutions lifecycle.

Why Work at Alira Health?

We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work programs, and more. We value passion, talent, entrepreneurial spirit, service, and teamwork.

Join Our Team

Our team includes over 800 scientists, strategists, economists, clinicians, and biostatisticians from over 30 nationalities, providing a broad global perspective. Apply to our open positions or send a spontaneous application.