Study Physician

Study Physician / Principal Investigator (m/f/d)

analyze & realize GmbH

Position Overview

To strengthen our study center, we are seeking a licensed Study Physician / Principal Investigator (PI). In this role, you will assume medical responsibility for study participants and lead the medical aspects of the study team. As PI, you play a key role in the execution and quality of our clinical trials.

The Study Physician / PI reports directly to the Managing Director of a&r GmbH.

Responsibilities

Medical Responsibilities (PI Role)

• Provide medical care and supervision of study participants throughout all study phases
• Conduct medical histories, physical examinations, and risk assessments
• Decide on the inclusion and exclusion of study participants according to the study protocol
• Review and assess laboratory results, vital signs, and clinical findings
• Evaluate and document AEs/SAEs in compliance with ICH-GCP requirements
• Ensure adherence to all medical, regulatory, and ethical standards
• Fulfil all responsibilities of the Principal Investigator as defined in the study protocol and GCP

Medical Leadership of the Study Center

• Provide medical leadership to the study team, including Study Nurses and other clinical staff
• (Study Nurses report to the PI)
• Ensure high-quality and compliant execution of clinical trial procedures
• Oversee accurate study documentation and medical data collection
• Support the continuous improvement and optimization of clinical workflows at the study center
• Serve as the primary medical contact for monitors, sponsors, and regulatory authorities

Cross-Functional Collaboration

• Close collaboration with Clinical Operations:
• Head of Clinical Operations Germany
• Director Clinical Operations Europe
• Collaboration with Consulting, Strategy & Innovation:
• Director Consulting, Strategy and Innovation
• Provide medical input on study design, feasibility assessments, and protocol adjustments
• Participate in project meetings and strategic planning sessions

Requirements

Professional Qualifications

• Valid medical license to practice in Germany
• Clinical experience in general medicine, internal medicine, pharmacology, or related fields
• Experience as PI or Sub-Investigator is an advantage
• Solid understanding of GCP guidelines and regulatory requirements
• Experience in clinical trials (Phase I–IV), ideally within an investigative site
• Proficiency in medical documentation, EDC systems, and SOP structures

Language Skills

• Excellent German skills
• Good English skills
• French language skills are an advantage

Personal Competencies

• Strong sense of medical responsibility and accuracy
• Clear and professional leadership style toward clinical staff
• Structured, independent, and reliable way of working
• Strong communication skills and solution-oriented mindset
• Interest in innovation and modern clinical trial operations

We Offer

• A key medical leadership position within a growing study center
• Active contribution to the redesign and strategic development of the study center, including:
• Digitalization of processes and workflows
• Implementation of AI-driven tools and automation
• Influence on spatial planning, infrastructure, and future operational models
• Close collaboration with international Clinical Operations teams
• Work in a committed, interdisciplinary environment
• Solid infrastructure with ongoing modernization and development
• Support from an experienced team of Study Nurses and recruitment staff
• Attractive opportunities for professional growth within the company

contact person:
Anna Lubicz-Stojanowska

E-Mail: -r.com