Clinical Trial Coordinator - single sponsor

Syneos Health Germany GMBH; Deubach; Hybrid; EUR 42.000 - 64.000; Vollzeit

Zusammenfassung

Syneos Health Germany GMBH is seeking a Clinical Trial Coordinator to support one sponsor across sites, ensuring adherence to protocol, ICH/GCP, and regulatory requirements. You will assist monitoring staff with site management and maintain project documentation.

The role emphasizes strong organizational skills, attention to detail, and effective communication with investigators and cross-functional teams. Minimal travel up to 10% may be required; associates degree or equivalent preferred.

Qualifikationen

• Experience in clinical research/pharma/biotech or related field; degree optional in lieu of experience
• Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
• Ability to prioritize and manage multiple tasks with strong organizational skills
• Excellent communication, presentation, and interpersonal skills
• Ability to embrace new technologies and adapt to changing processes
• Minimal travel up to 10% may be required

Aufgaben

• Perform activities in compliance with Corporate and Clinical Operations Policies, SOPs and Work Instructions
• Assist Clinical Monitoring staff with site management and Sponsor communications
• Create and maintain project files and correspondence
• Participate in file audits and maintain site manuals and reference tools
• Input and update clinical tracking information in databases
• Track regulatory documents for investigator sites and project teams
• Coordinate site supplies ordering, packaging, shipping and tracking
• Assist with team meetings and record accurate minutes and actions
• Provide training or mentorship to junior COS where applicable
• Maintain field awareness through required trainings

Kenntnisse

Clinical research experience

Medical terminology

ICH/GCP knowledge

Prioritization

Attention to detail

Communication skills

Adaptability to new technologies

Travel willingness

Ausbildung

Associates degree or equivalent

Jobbeschreibung

Clinical Trial Coordinator - single sponsor Syneos Health® is a leading fully 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. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. 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 accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 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.

Job Responsibilities

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of project files, handles project correspondence
• Participates in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

Qualifications

• Associates degree preferred or equivalent
• Experience in clinical research/pharma/biotech or related field considered In lieu of degree
• Good knowledge of medical terminology, clinical data, and ICH/GCP preferred
• Ability to successfully prioritize and work on multiple tasks
• Strong attention to detail, accuracy and organizational skills
• Excellent communication, presentation, and interpersonal skills
• Ability to embrace new technologies
• Minimal travel up to 10% may be required

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 us as an employer secures a career in which you’re guaranteed to: 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.

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