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- Aufgaben: Manage clinical research sites and ensure compliance throughout the study phases.
- Arbeitgeber: Join Syneos Health, a leader in biopharmaceutical solutions dedicated to improving patient lives.
- Mitarbeitervorteile: Enjoy a home-based role with flexible work options and opportunities for professional growth.
- Warum dieser Job: Make a real impact in healthcare while collaborating with global experts in a supportive environment.
- GewĂĽnschte Qualifikationen: Requires a B.A./B.S. in science, 2+ years of monitoring experience, and fluency in German and English.
- Andere Informationen: Diversity and inclusion are core values; transferable skills are welcomed.
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
Clinical Research Associate (II/Sr) – home based, sponsor dedicated, full-time, Germany
Updated: February 21, 2025
Location: Germany-Europe – DEU-Home-Based
Job ID: 25001898
Clinical Research Associate (II/Sr) – home based, sponsor dedicated, full-time, Germany
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world.
Here at Syneos Health we are currently recruiting for aClinical Research Associate opening,to work on a sponsor-dedicated role in Germany.The roles are part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.
Your responsibilities:
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects’ right, safety and well-being are protected
Qualifications
- Min B.A./B.S. required with strong emphasis in science and/or biology coupled with relevant work experience.
- Min. 2 years of direct onsite monitoring experience in a bio/pharma./CRO (the more you have, the role will be adjusted to your level) is required. Previous monitoring experience in Neurology and Oncology are also required.
- Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively is mandatory.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately.
- Willingness to perform 8 onsite monitoring visits per month, within Germany.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles.
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
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Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany Arbeitgeber: Syneos Health, Inc.
Kontaktperson:
Syneos Health, Inc. HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany
✨Tip Number 1
Familiarize yourself with the specific requirements of the Clinical Research Associate role, especially in Neurology and Oncology. Understanding these areas will help you demonstrate your expertise during interviews.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, particularly those who work at Syneos Health or similar organizations. Engaging with them can provide insights into the company culture and expectations for the role.
✨Tip Number 3
Prepare to discuss your experience with ICH-GCP guidelines and site management during interviews. Be ready to share specific examples of how you've ensured compliance and improved site performance in past roles.
✨Tip Number 4
Showcase your IT skills and adaptability with clinical applications. Highlight any experience you have with CTMS, eTMF, or other relevant systems, as this will be crucial for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany
Tipps für deine Bewerbung 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Clinical Research Associate position. Familiarize yourself with the specific tasks mentioned in the job description to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your direct onsite monitoring experience, especially in Neurology and Oncology. Provide specific examples of how you've managed site performance and patient recruitment to demonstrate your suitability for the role.
Showcase Language Proficiency: Since fluency in both German and English is mandatory, ensure that your application reflects your language skills. If applicable, mention any relevant certifications or experiences that highlight your communication abilities in both languages.
Tailor Your Application: Customize your cover letter to reflect your understanding of Syneos Health's mission and values. Explain why you are passionate about improving patients' lives and how your background aligns with their goals in the biopharmaceutical industry.
Wie du dich auf ein Vorstellungsgespräch bei Syneos Health, Inc. vorbereitest
✨Understand the Clinical Research Landscape
Make sure you have a solid grasp of clinical research processes, especially ICH-GCP guidelines and local regulations. Being able to discuss these topics confidently will show your expertise and commitment to the role.
✨Demonstrate Your Monitoring Experience
Prepare to share specific examples from your previous monitoring roles, particularly in Neurology and Oncology. Highlight how you've managed site performance and patient recruitment effectively.
✨Showcase Your Communication Skills
Since this role requires excellent communication with site staff and investigators, practice articulating complex information clearly. Be ready to discuss how you've navigated challenging conversations in the past.
✨Familiarize Yourself with the Company
Research Syneos Health and its mission to improve patients' lives. Understanding the company's values and how they align with your own can help you convey genuine interest during the interview.
