Description

Clinical Operations Specialist - die Schweiz

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

Für eine unserer Single Sponsor Partnerschaften hier in der Schweiz suchen wir derzeit einen Clinical Operations Specialist.

Dies ist eine hybride Rolle, in der Sie 2 bis 3 Tage pro Woche von unserem Büro in Luzern aus arbeiten werden.

Die Verantwortlichkeiten sind:

• Verantwortlich für die Aktivitäten in Übereinstimmung mit den geltenden Corporate und Clinical Operations Policies, Standard Operating Procedures und Arbeitsanweisungen
• Unterstützt das Clinical Monitoring Personal bei Site Managment aktivitäten, einschließlich der Vertretung des Sponsors für Sites bei zugewiesenen Studien und der Kommunikation mit Sites, um die Compliance der Protokollanforderungen, Studienverfahren und relevanten Richtlinien sicherzustellen
• Erstellt und unterstützt bei der Pflege der Trial Master File (TMF) und Projektakten, einschließlich der Teilnahme an Audits
• Bereitet Site Manuals, Referenzwerkzeuge und andere Dokumente vor und pflegt diese
• Hält klinische Verfolgungsinformationen in Datenbanken aktuell, aktualisiert und gibt sie ein
• Verfolgt eingehende und ausgehende klinische und regulatorische Dokumente und Aktualisierungen für Investigator Sites, Studien, Projektteams oder Kunden
• Verwalte das gemeinsame Mailbox, bearbeitet Site fragen und leitet die Korrespondenz entsprechend weiter
• Koordiniert die Bestellung, Verpackung, den Versand und die Nachverfolgung von Site vorräten und Materialien
• Unterstützt die Koordination von Teammeetings, nimmt an Meetings teil und erstellt genaue Protokolle und Aktionspunkte
• Kann den Empfang, die Nachverfolgung und die Behandlung von Case Report Forms and Queries übernehmen
• Hält sich im Bereich der klinischen Forschung auf dem neuesten Stand, indem alle erforderlichen und zugewiesenen Schulungen absolviert werden.

Wir suchen einen neuen Kollegen mit den folgenden Qualifikationen:

• Hohe Schulbildung oder gleichwertig
• Gute Kommunikations- und zwischenmenschliche Fähigkeiten
• Fähigkeit, neue Technologien zu übernehmen
• Ein Hintergrund in klinischer Forschung wäre willkommen
• Fließend in Englisch und Deutsch

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.

Summary

Roles within Clinical Operations at the S11 level are responsible for ensuring the safe and effective operations of clinical research studies. This includes safeguarding the wellbeing of research subjects in a medical capacity, reviewing study protocols, and executing procedures in alignment with protocols and regulatory, health, and safety standards. These roles involve recruiting and coordinating communication with clinical trial volunteers and patients, and following applicable regulations globally and by region. Collaboration with cross-functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study is also a key aspect of these roles.Impact and ContributionRoles within Clinical Operations at the S11 level significantly contribute to the success of clinical research studies by ensuring that all operations are conducted safely and effectively. By safeguarding the wellbeing of research subjects and adhering to regulatory standards, these roles help maintain the integrity and reliability of clinical trials. The coordination and communication with clinical trial volunteers and patients ensure smooth and efficient study progress. Collaboration with cross-functional teams enhances the development of study materials and the resolution of any issues, ultimately contributing to the advancement of medical research and the development of new treatments.Core Focus•Safeguarding the wellbeing of research subjects in a medical capacity•Reviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standards•Recruiting and coordinating communication with clinical trial volunteers and patients•Following applicable regulations globally and by region•Collaborating with cross-functional teams to develop study materials•Monitoring trial progress and addressing any issues that arise during the study•Providing organizational related support or service, typically under supervision•Performing routine tasks with some deviation from standard practice•Utilizing broad knowledge of operational systems and practices gained through extensive experience and/or education