Clinical Research Associate Germany (remote, 0.8-1.0 FTE)

P95; Deutschland; On-site; EUR 63,000 - 90,000; Full time

Job summary

P95 and Julius Clinical have recently joined forces to advance global health through epidemiological research and clinical trials. The Senior Clinical Research Associate (CRA) will own monitoring across assigned trials, ensuring quality, safety and data integrity, with a focus on ICH-GCP and regulatory compliance.

Based in Germany, you will lead site visits, SDV/SDR, and risk-based monitoring, collaborating with investigators, sponsors, and internal teams.

Qualifications

• A Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, Biomedical Sciences, or a related field.
• 3+ years' experience as a CRA on clinical trials (IP preferred).
• Solid knowledge of ICH-GCP, clinical trial regulations, and monitoring practices.
• Experience conducting independent monitoring visits across multiple sites.

Responsibilities

• Independently perform and lead Site Selection, Site Initiation, Monitoring and Close-Out Visits across trials.
• Oversee site conduct with protocol, ICH-GCP and sponsor expectations.
• Perform SDV/SDR and ensure accurate study documentation and monitoring reports.
• Apply risk-based monitoring to identify trends and escalate issues.
• Identify and manage protocol deviations, safety information, and site performance concerns.
• Maintain relationships with investigators, sponsors, and internal teams, and assist with inspections and CAPA.
• Support start-up, recruitment, maintenance, and close-out activities, including regulatory submissions.
• Contribute monitoring insights to study teams and improve monitoring tools and processes.
• Ensure compliant use of CTMS, eTMF, and EDC systems.

Skills

Fluent English

Fluent German

Strong communication

Organizational skills

Education

Bachelor's or Master's in Life Sciences

Tools

CTMS

eTMF

EDC

MS Office

Job description

About us

P95 and Julius Clinical have recently joined forces, bringing together two highly complementary organizations with a shared mission: advancing global health through high‑quality epidemiological research and clinical trials.

About us

P95 and Julius Clinical have recently joined forces, bringing together two highly complementary organizations with a shared mission: advancing global health through high‑quality epidemiological research and clinical trials. P95, founded in 2011 and headquartered in Belgium, is a global leader in epidemiology, vaccines, and infectious disease research. With offices across Europe, North America, South America, Africa, and Southeast Asia, P95 supports public health agencies, pharmaceutical companies, academic institutions, and global organizations such as WHO and the European Commission. Our work focuses on generating timely, pragmatic, and actionable insights to improve access to safe and effective vaccines. Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a leading clinical CRO known for its strong scientific leadership and operational excellence. With more than 400 clinical trials conducted and over 300,000 participants enrolled worldwide, Julius Clinical specializes in central nervous system, cardio‑metabolic, renal, and rare diseases, working closely with biotech and mid‑sized pharma partners. Together, we form a global, science‑driven organization offering an integrated portfolio of epidemiological and clinical research services. Our teams combine deep scientific expertise, operational excellence, and a shared passion for improving healthcare outcomes. P95 and Julius Clinical (JC) are part of the Ampersand Capital Partners portfolio, a healthcare‑focused private equity firm. We are united by a commitment to scientific rigor, innovation, and meaningful impact and we are excited to welcome new colleagues who share our ambition to improve global health.

Responsabilities

As a Senior Clinical Research Associate (CRA), you will take ownership of monitoring activities across assigned clinical trials, ensuring high standards of quality, compliance, and site performance. Your key responsibilities will include:

• Independently perform and lead Site Selection, Site Initiation, Monitoring and Close-Out Visits, including complex protocols and higher-risk sites.
• Oversee site conduct and compliance with the study protocol, ICH-GCP, regulatory requirements, and sponsor expectations, with a strong focus on patient safety and data integrity.
• Perform Source Data Verification (SDV) and Source Data Review (SDR) and ensure accurate, complete, and timely study documentation and monitoring reports.
• Apply a risk‑based monitoring approach, identifying trends and risks, prioritising activities, and driving appropriate follow‑up and resolution.
• Proactively identify and manage protocol deviations, compliance issues, safety information, site performance concerns, and other study risks, escalating where appropriate.
• Maintain strong relationships with investigators, site teams, sponsors, and internal study teams, providing expert guidance and acting as an escalation point for complex site and monitoring matters.
• Drive site and study inspection readiness, supporting audits and inspections and contributing to CAPA development and follow‑up where required.
• Support study activities throughout the start‑up, recruitment, maintenance, and close‑out phases, including regulatory and Ethics Committee activities where applicable.
• Contribute monitoring insights and recommendations to study teams and investigator meetings and support continuous improvement of monitoring tools, processes, and approaches.
• Ensure high‑quality and compliant use of clinical trial systems, including CTMS, eTMF and EDC, and maintain strong standards for documentation and follow‑up.

Experience

The ideal candidate will have

• A Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, Biomedical Sciences, or a related field.
• A minimum of 3 years' experience as a CRA on clinical trials (preferably with IP).
• Solid knowledge of ICH-GCP, clinical trial regulations, and monitoring practices.
• Experience conducting independent monitoring visits across multiple sites.
• Demonstrated ability to thrive under pressure and manage multiple priorities effectively.
• Advanced problem‑solving skills and a proactive approach to challenges.
• Proven ability to plan and organize complex tasks with precision.
• Strong collaboration skills, resolving issues in a constructive and team‑oriented manner.
• A track record of maintaining high standards and accuracy in all deliverables.
• Exceptional flexibility and adaptability in dynamic environments.

Experience - you must also have these skills

• Fluency in German and English (written and spoken).
• Residence in Germany.
• Willingness and ability to travel regularly within Germany and occasionally internationally.
• Strong communication and interpersonal skills.
• Ability to work independently while being an effective team player.Flexible and adaptable approach to work.
• Excellent organizational skills with attention to detail and a “getting the job done” mindset.
• Client‑focused attitude and commitment to delivering high‑quality results on time.
• Proficiency in Microsoft Office and willingness to learn new software and systems.
• Cultural sensitivity and ability to collaborate across diverse international teams.