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Biologe (m/w/d) Clinical Science (m/w/d) IRT Specialist (m/w/d) - Job Opportunity at agento Personal Management GmbH

Biberach an der Riß, Germany
Full-time
Senior
Posted: June 23, 2025
Hybrid
EUR 68,000 per year

Benefits

Employment with one of the world's top pharmaceutical companies providing exceptional career stability and growth opportunities
Equal monthly gross salary as permanent employees from day one, ensuring fair compensation without probationary period disadvantages
Annual salary of approximately 68,000 EUR including yearly bonus, positioning competitively in the German pharmaceutical market
Personal support through dedicated contact persons, ensuring smooth integration and ongoing professional development
Secure long-term employment with excellent prospects for permanent placement, reducing career uncertainty
Fair and trustful working environment fostering collaboration and professional respect
Hybrid work model allowing 2-3 days remote work per week, providing optimal work-life balance and flexibility
Comprehensive on-site training program ensuring thorough preparation for independent work

Key Responsibilities

Lead autonomous management of all IRT-related activities across the complete lifecycle from evaluation and planning through implementation to maintenance and decommissioning, directly impacting study success and regulatory compliance
Function as independent IRT specialist within cross-organizational study and project teams, driving technical implementation of IRT concepts while ensuring alignment with clinical study design requirements
Contribute to continuous advancement of IRT concepts through expert knowledge of complex study designs, positioning the organization at the forefront of clinical trial technology
Ensure all work maintains highest standards of patient safety while adhering to GMP, GCP, and international regulatory guidelines across US, EU, and global markets
Develop comprehensive operational process descriptions and work instructions independently, establishing standardized procedures that enhance organizational efficiency and compliance

Requirements

Education

Completed Master's degree in natural sciences with several years of relevant professional experience or completed Bachelor's degree in natural sciences with extensive relevant professional experience

Experience

Several years of relevant professional experience for Master's degree holders or extensive experience for Bachelor's degree holders

Required Skills

Complex task completion independently, efficiently and responsibly under consideration of applicable regulations, economic efficiency and time requirements Negotiation-level proactive and targeted communication skills in German and English, both written and oral Quick comprehension ability and capability to develop processes and workflows independently Ability to develop new strategies, innovations, methods and work concepts to increase standardization and efficiency Initiative for non-routine processes and independent execution Implementation of complex project requirements, complex study designs including associated IRT requirements and technical specifications
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented digital transformation with Interactive Response Technology (IRT) becoming critical for clinical trial efficiency and patient safety. Organizations are increasingly investing in advanced IRT systems to streamline randomization, drug supply management, and patient visit scheduling, making IRT specialists highly valuable in the current market. Regulatory complexity continues to intensify across global markets, with harmonized GCP and GMP requirements driving demand for professionals who can navigate multi-regional compliance frameworks. The convergence of US FDA, EMA, and other international regulatory standards requires specialized expertise that commands premium compensation. Clinical trial digitalization and patient-centric approaches are reshaping study design methodologies, with hybrid and decentralized clinical trials becoming mainstream. This shift creates substantial opportunities for IRT specialists who can design and implement flexible, technology-enabled solutions that improve patient experience while maintaining regulatory compliance.

Salary Evaluation

The offered salary of EUR 68,000 annually positions this role competitively within the German pharmaceutical market for senior-level IRT specialists. This compensation level reflects the specialized nature of the position and aligns with industry standards for experienced clinical science professionals in the Baden-Württemberg region, where Biberach is located.

Role Significance

Typically operates within cross-functional teams of 8-15 professionals including clinical operations, biostatistics, regulatory affairs, and data management specialists, with potential to lead IRT-specific sub-teams of 3-5 members.
This is a senior-level position requiring autonomous decision-making, cross-functional leadership, and strategic contribution to clinical trial design and implementation. The role carries significant responsibility for patient safety and regulatory compliance across international markets.

Key Projects

Implementation of complex adaptive clinical trial designs with sophisticated randomization algorithms Multi-regional clinical trial launches requiring harmonized IRT systems across different regulatory jurisdictions Development and validation of innovative IRT solutions for rare disease studies and personalized medicine trials Integration of IRT systems with electronic data capture (EDC) and clinical trial management systems (CTMS)

Success Factors

Deep understanding of clinical trial methodology combined with strong technical acumen in IRT system configuration and validation enables effective translation of complex study designs into functional technology solutions Proactive communication and stakeholder management skills are essential for coordinating across multiple functional areas and ensuring alignment between clinical, regulatory, and operational requirements Regulatory expertise spanning GCP, GMP, and international guidelines provides the foundation for ensuring compliant implementation while managing risk across diverse global markets Strategic thinking and innovation capabilities allow for continuous improvement of IRT processes and contribution to competitive advantage in clinical development timelines

Market Demand

High demand driven by increasing clinical trial complexity, regulatory requirements, and industry digitalization initiatives requiring specialized IRT expertise.

Important Skills

Critical Skills

GCP and GMP regulatory compliance expertise is absolutely essential as any deviation from these standards can result in study delays, regulatory sanctions, and significant financial impact. The ability to ensure compliant implementation across multiple international jurisdictions directly affects patient safety and organizational risk management. Complex study design understanding combined with IRT technical implementation skills represents the core value proposition of this role. The ability to translate sophisticated clinical protocols into functional technology solutions determines study feasibility and execution success. Cross-functional communication and project management capabilities are vital for coordinating across diverse stakeholder groups including clinical operations, biostatistics, regulatory affairs, and technology teams. Success depends on building consensus and driving alignment among competing priorities and perspectives.

Beneficial Skills

Advanced knowledge of emerging clinical trial technologies such as artificial intelligence, machine learning, and predictive analytics enhances ability to contribute to next-generation IRT solutions and positions for leadership in digital clinical trials Experience with decentralized and hybrid clinical trial models provides competitive advantage as the industry continues shifting toward patient-centric approaches and virtual trial components Regulatory affairs expertise beyond GCP/GMP, including knowledge of digital health regulations and data privacy frameworks like GDPR, becomes increasingly valuable as clinical trials incorporate more digital technologies and patient data collection methods

Unique Aspects

The position offers immediate salary parity with permanent employees, eliminating the typical compensation disadvantage associated with temporary staffing arrangements and demonstrating the client company's commitment to attracting top talent
Hybrid work model with 2-3 days remote flexibility represents progressive approach to work-life balance in the traditionally conservative pharmaceutical industry, indicating the client organization's adaptability to modern work preferences
Direct involvement in cutting-edge IRT concept development provides opportunity to influence the future direction of clinical trial technology and contribute to industry best practices
Cross-functional team leadership role offers substantial visibility and networking opportunities within a global pharmaceutical organization, accelerating career development potential

Career Growth

Progression to management roles typically occurs within 3-5 years given the specialized nature of IRT expertise and strong demand for experienced leaders in clinical operations.

Potential Next Roles

Senior IRT Manager with oversight of multiple IRT specialists and strategic responsibility for organizational IRT capabilities Clinical Operations Director focusing on digital clinical trial technologies and patient-centric study design Regulatory Affairs Director specializing in digital health technologies and clinical trial innovation Independent consultant providing IRT expertise to biotechnology companies and clinical research organizations

Company Overview

agento Personal Management GmbH

Agento Personal Management GmbH operates as a specialized staffing and personnel management company focusing on pharmaceutical and life sciences sectors. The company serves as an intermediary connecting highly qualified professionals with leading pharmaceutical organizations, particularly in the German market.

Established as a recognized player in pharmaceutical staffing with strong relationships among major pharmaceutical companies in Germany, enabling access to exclusive opportunities with global industry leaders.
Strong presence in the Baden-Württemberg region, particularly around pharmaceutical hubs like Biberach, with deep understanding of local market dynamics and compensation standards in the German pharmaceutical sector.
Professional staffing environment emphasizing long-term career development and successful permanent placement, with focus on matching qualified candidates to roles that align with their career objectives and growth potential.
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