Senior CRA/CRA II in oncology trials

Syneos Health Germany GMBH; Deutschland; Remoto; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Syneos Health Germany GmbH invites applications for a Senior CRA/CRA II in oncology trials. You will oversee on-site monitoring across trial phases, ensuring ICH/GCP compliance, data integrity, and timely reporting. Strong CTMS experience and multilingual capabilities (English/German) are essential.

Join a global life sciences services leader focused on delivering clinically meaningful results. You’ll work in a fast-paced, collaborative environment with a mission-driven mindset and opportunities

Competenze

• Experience in oncology trials across phases, including fast-paced environments.
• Proven on-site monitoring, source data verification and IP accountability.
• Strong communication, teamwork and problem-solving in a regulated setting.

Mansioni

• Monitor clinical trial sites to ensure data integrity and patient safety.
• Prepare and submit comprehensive visit reports and CTMS documentation.
• Collaborate with sponsors, sites and internal teams to resolve issues.

Conoscenze

Oncology expertise

Solid tumor knowledge

CTMS proficiency

Monitoring on-site

English & German

Collaboration & adaptability

Strumenti

Siebel CTMS

Veeva Vault CTMS

Medidata CTMS

Oracle Clinical/Clinical One

Descrizione del lavoro

Senior CRA/CRA II in oncology trials

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

We are continuously building the company we all want to work for and our customers want to work with.

Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

For one of our clients we are looking for a well-qualified CRA with a strong background in oncology clinical trials across all phases of development, including early phase/first in human studies, safety, PK/PD, and dose escalation designs. The ideal candidate will have hands on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer, and will be comfortable operating in fast paced development environments where quality execution supports accelerated timelines and regulatory submissions. Prior exposure to investigational products involving Toll Like Receptor (TLR) pathways, PARP1 inhibitors, or Werner helicase protein is desirable but not required. This role requires demonstrated proficiency in traditional on site monitoring models, including full source data verification, investigational product accountability, and strict adherence to ICH/GCP and regulatory requirements. Candidates must have a proven track record of managing visit activities efficiently while producing accurate, comprehensive, and timely monitoring visit and trip reports. Extensive experience working within CTMS platforms such as Siebel CTMS, Veeva Vault CTMS, Medidata CTMS, Oracle Clinical/Clinical One, or similar systems is expected. Multilingual capabilities, particularly fluency in English German are strongly preferred. Successful candidates will bring a mission driven and intellectually curious mindset, with a strong sense of ownership and a collaborative, adaptable approach to clinical operations. We value individuals who demonstrate professionalism, attention to detail, reliability, and ethical decision making, along with strong communication and teamwork skills. The ability to thrive in a high urgency environment, leverage digital tools effectively, maintain a customer focused approach with sites and stakeholders, and proactively identify and resolve issues is essential to ensuring trial integrity and success.

Required Technical Skills

• Oncology Expertise: all phases of development
• Indication‑Specific Knowledge: solid tumor
• Traditional Monitoring Model: Solid skills and proficiency in on‑site monitoring, full source data verification, IP accountability and regulatory compliance.
• Trip Report Writing: Proven track record in producing accurate, comprehensive, and timely monitoring visit reports, with extensive experience using any CTMS platform (such as Siebel CTMS, Veeva Vault CTMS, Medidata CTMS, Oracle Clinical/Clinical One, or similar systems)
• Additional Skills: multilingual - English and German
• Culture‑Specific & Desired Soft Skills: Mission‑focused & intellectually curious: a collaborative mindset with a passion for pushing boundaries and tackling complex challenges to create solutions that matter.
• Collaborative and adaptable mindset: strong professionalism (ethics, detail focus, reliability) with excellent collaboration (communication, teamwork, building trust) and adaptability to a fast‑paced environment (sense of urgency for the mission), emphasizing quality, digital fluency (CTMS, eTMF, remote tools) and customer service to sites and sponsors, all while maintaining a proactive, problem‑solving mindset to ensure trial integrity and success.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment.

Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our Syneos Health colleagues already know: work here matters everywhere.

Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting… Secured job ensures a career …

Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.