Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany
Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany

Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany

Vollzeit 43200 - 72000 € / Jahr (geschätzt) Kein Home Office möglich
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Auf einen Blick

  • Aufgaben: Manage clinical research sites and ensure compliance throughout all study phases.
  • Arbeitgeber: Join Syneos Health, a leading biopharmaceutical company dedicated to improving patient lives globally.
  • Mitarbeitervorteile: Enjoy a comprehensive benefits program focusing on your physical, mental, and financial health.
  • Warum dieser Job: Be part of a diverse team where your unique contributions make a real difference in healthcare.
  • Gewünschte Qualifikationen: Requires a B.A./B.S. in science, 2+ years of monitoring experience, and fluency in German and English.
  • Andere Informationen: Work remotely while conducting site visits across Germany, with opportunities for professional growth.

Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.

Description

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. Because to us, a patient isn\’t just a number, they\’re our family, friends, and neighbors.

Here at Syneos Health we are currently recruiting for a Clinical 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.

Why Syneos Health

  1. #SyneosHealthLife means we\’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person\’s unique contributions make a difference.
  2. We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That\’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
  3. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we\’re able to create a place where everyone feels like they belong.

Your responsibilities:

  1. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
  2. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
  3. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  4. Gains an in-depth understanding of the study protocol and related procedures.
  5. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
  6. Participates & provides inputs on site selection and validation activities.
  7. Performs remote and on-site monitoring & oversight activities using various tools to ensure:
  1. Data generated at site are complete, accurate and unbiased
  2. Subjects\‘ right, safety and well-being are protected
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.
  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
  • Supports and/or leads audit/inspection activities as needed.
  • Qualifications

    1. Min B.A./B.S. required with strong emphasis in science and/or biology coupled with relevant work experience.
    2. 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.
    3. Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively is mandatory.
    4. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
    5. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
    6. Hands on knowledge of Good Documentation Practices.
    7. Proven Skills in Site Management including management of site performance and patient recruitment.
    8. Demonstrated high level of monitoring skill with independent professional judgment.
    9. 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.
    10. Ability to understand and analyze data/metrics and act appropriately.
    11. Willingness to perform 8 onsite monitoring visits per month, within Germany.

    #J-18808-Ljbffr

    Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany Arbeitgeber: Syneos Health Careers

    At Syneos Health, we pride ourselves on being an exceptional employer, offering a vibrant work culture that champions diversity and inclusion. Our Total Self culture empowers you to bring your authentic self to work while providing comprehensive benefits that support your physical, mental, and financial well-being. With endless opportunities for professional growth and the chance to make a meaningful impact on patients' lives, joining our team as a Clinical Research Associate in Germany means becoming part of a dedicated community committed to excellence and innovation in clinical research.
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    Kontaktperson:

    Syneos Health Careers HR Team

    StudySmarter Bewerbungstipps 🤫

    So bekommst du den Job: Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany

    ✨Tip Number 1

    Make sure to highlight your experience in onsite monitoring, especially in Neurology and Oncology. These specific areas are crucial for this role, so be prepared to discuss your relevant experiences in detail during the interview.

    ✨Tip Number 2

    Familiarize yourself with ICH-GCP guidelines and local regulations. Being able to demonstrate your knowledge of these standards will show that you are well-prepared for the responsibilities of a Clinical Research Associate.

    ✨Tip Number 3

    Network with current or former employees of Syneos Health. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach during the application process.

    ✨Tip Number 4

    Prepare to discuss your IT skills and experience with clinical applications. Since the role requires good IT proficiency, being able to articulate your comfort with various tools will set you apart from other candidates.

    Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany

    Clinical Research Knowledge
    Site Management Skills
    Monitoring Experience in Neurology and Oncology
    Fluent in German and English (verbal and written)
    Excellent Communication Skills
    Understanding of ICH-GCP Guidelines
    Knowledge of Regulatory Documentation
    Good Documentation Practices
    Data Analysis Skills
    IT Proficiency (MS Office, Clinical IT Applications)
    Problem-Solving Skills
    Ability to Work Independently
    Team Collaboration Skills
    Adaptability to New Technologies
    Time Management Skills

    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. Tailor your application to highlight relevant experiences in site management and monitoring.

    Highlight Relevant Experience: Emphasize your direct onsite monitoring experience, especially in Neurology and Oncology. Provide specific examples of how you've successfully managed sites and ensured compliance with GCP and ICH guidelines.

    Showcase Communication Skills: Since excellent communication skills are mandatory, include examples of how you've effectively communicated with investigators and site staff. Mention your fluency in both German and English, as this is crucial for the role.

    Tailor Your CV and Cover Letter: Customize your CV and cover letter to reflect the job description. Use keywords from the job posting and demonstrate how your skills and experiences align with Syneos Health's values and the Total Self culture.

    Wie du dich auf ein Vorstellungsgespräch bei Syneos Health Careers vorbereitest

    ✨Understand the Role and Responsibilities

    Make sure you have a clear understanding of the responsibilities of a Clinical Research Associate. Familiarize yourself with the phases of clinical trials, ICH-GCP guidelines, and the specific requirements mentioned in the job description.

    ✨Showcase Your Monitoring Experience

    Be prepared to discuss your previous monitoring experience, especially in Neurology and Oncology. Highlight specific examples where you successfully managed site performance and patient recruitment.

    ✨Demonstrate Communication Skills

    Since excellent communication skills are mandatory, practice articulating complex information clearly and concisely. Be ready to explain how you would communicate with investigators and site staff regarding protocol conduct and compliance issues.

    ✨Prepare for Technical Questions

    Expect questions related to Good Documentation Practices and your familiarity with clinical IT applications. Brush up on your IT skills and be ready to discuss how you adapt to new technologies in your work.

    Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany
    Syneos Health Careers
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    • Clinical Research Associate (II/Sr) - home based, sponsor dedicated, full-time, Germany

      Vollzeit
      43200 - 72000 € / Jahr (geschätzt)

      Bewerbungsfrist: 2027-03-31

    • S

      Syneos Health Careers

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