Clinical Operations Coordinator

Vor 2 Tagen

Zurich, Schweiz Alvotech Vollzeit

**Overview of Role**

**Scope and responsibility (Job description 50skillls)**
- Ensure all assigned trial deliverables are met according to timelines, budget, operational procedures and quality / GCP standards.
- Oversee and maintain Trial Master File (TMF) in strict compliance with ICH/GCP and internal SOPs
- Assist with setting up sponsor Oversight and Risk Management documentation according to Alvotech Standard Operating Procedures (SOPs)
- Review Green Light Approval documentation including Competent Authority and Ethics Committee approvals
- Review Informed Consent Form (ICF), Data Privacy terms and other patient facing material and ensure consistent with study protocol
- Review study documents and plans developed by the CRO (e.g. Pharmacy Manual, Communication Plan, study training material)
- Ensure regular reporting of important trial issues, status and progress of the trial, timely escalating any (urgent) issues to the Clinical Operations Lead
- Perform co-sponsor visits to clinical sites and write sponsor Site Visit Reports
- Review Monitoring Visit Reports
- Prepare Transfer of Regulatory Obligation documents
- Obtain Clinical Trial Insurance

**Job requirements**
- Education: (Minimum) Bachelor of Sciences or equivalent.
- Experience: 2+ years in relevant functions in the Pharmaceutical Industry, or equivalent.
- Previous experience participating in clinical trials in a Pharma/Biopharmaceutical company, a CRO or Clinical Site, along with a basic knowledge of the EMA and FDA clinical/regulatory environment.
- Basic knowledge of GCP and other relevant ICH/regulatory guidelines.
- Proficient in use of IT systems, databases and common software packages such as Word, Visio, Excel, Powerpoint, MSProject, Sharepoint, MSTeams.

**What we offer**:

- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Internet at home for full-time employees.

**Why Alvotech**

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

  • Study Nurse

    vor 7 Monaten

    Zurich, Schweiz Universitätsspital Zürich Klinik für Plastische Chirurgie und Handchirurgie Vollzeit

    Universitätsspital Zürich_ - Klinik für Plastische Chirurgie und Handchirurgie_ **Study Nurse / Clinical Research Coordinator** **80-100% **:Das UniversitätsSpital Zürich ist eines der grössten Spitäler in der Schweiz. Unsere über 8000 Mitarbeitenden setzen sich täglich für das Wohl unserer Patient:innen ein. Bei uns finden Sie ein attraktives und...

  • Clinical Operations Manager

    vor 12 Stunden

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a **Clinical Operations Manager in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** Lead study operational strategy and planning and oversee execution of clinical studies for an assigned...

  • Clinical Trial Manager

    Vor 4 Tagen

    Zurich, Schweiz Numab Therapeutics AG Vollzeit

    Numab Therapeutics AG, with its US subsidiary Numab US LLC, is an expanding, clinical stage Swiss biotech company based in Horgen, canton of Zürich. The company is focused on the discovery and development of novel, antibody fragment-based therapeutics. With our breakthrough antibody-discovery and multi-specifics engineering platform, we engage in...

  • Clinical Operation Manager:in

    Vor 6 Tagen

    Zurich, Schweiz UniversitätsSpital Zürich Vollzeit

    **per sofort oder nach Vereinbarung**: **Ihre Hauptaufgaben**: - Sie arbeiten in einem multidisziplinären Team, um den Bereich Clinical Operations in einem Next Generation Sequencing (NGS) Labor Labor im routinemässigen Einsatz und für klinische Studien zu unterstützen - Dabei arbeiten Sie eng mit der operativen Leitung zusammen und übernehmen...

  • Clinical Director, Clinical Research

    vor 8 Monaten

    Zurich, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ‘follow the science’ and that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference...

  • Care Coordinator

    vor 12 Stunden

    Zurich, Schweiz Handup Foundation Vollzeit

    We are seeking a dedicated care coordinator to assist us with patients enrolled at our facility **Responsibilities**: - Consult with patients and family members to discuss their health problems. - Educate patients about their condition, medication, and give them specific instructions. **Requirements**: - At least 3 years' experience in care coordination...

  • Clinical Trial Manager

    Vor 6 Tagen

    Zurich, Schweiz Denali Therapeutics Vollzeit

    **Clinical Trial Manager** ***Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. **The Opportunity** The Clinical Trial Manager (CTM) is responsible managing the day-to-day operations of assigned clinical studies...

  • Associate Director of Strategy, Vault Clinical Ops

    vor 1 Woche

    Zurich, Schweiz Veeva Systems Vollzeit

    Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more...

  • City Operations Coordinator

    vor 2 Wochen

    Zurich, Schweiz Kooky CEBS AG Vollzeit

    Wir sind kooky, ein innovatives Startup welches Einwegverpackungen den Kampf ansagt. Zusammen mit dir wollen wir die Take-Away Industrie mit einer simplen, nachhaltigen Alternative - dem wiederverwendbaren kooky Becher - revolutionieren. Bereits seit Juli 2021 ist unser Mehrwegsystem inklusive eigener Rückgabeinfrastruktur in Zürich und Basel zu finden....

  • Technical Coordinator

    vor 7 Monaten

    Zurich, Schweiz SR Technics Vollzeit

    Technical Coordinator The Technical Coordinator helps the customer in solving technical problems on his fleet. He is the customers entry point into SR Technics operation / organisation. Technical Coordinator is also responsible for maintaining records of customer interactions and collaborating with 3rd parties. Main Tasks - To promote a positive Safety...

  • Clinical Research Associate Lead

    vor 12 Stunden

    Zurich, Schweiz Translational Research in Oncology Vollzeit

    If you are an experienced CRA Lead who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate...

  • Clinical Project Manager

    vor 7 Monaten

    Zurich, Schweiz SIVA Health AG Vollzeit

    SIVA Health AG is a digital health startup company in the field of sound-based respiratory diagnostics, located in Zurich, Switzerland. Through collaboration with global corporate partners, clinics, and researchers, we at SIVA Health have developed a novel device to continuously measure cough (24/7). This innovation is currently being used in global clinical...

  • Clinical Scientist, Late Stage Development

    vor 1 Woche

    Zurich, Schweiz Denali Therapeutics Vollzeit

    **Clinical Scientist,** Late Stage Clinical Development** **The Opportunity** Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative and rare diseases through our deep commitment to degeneration biology and principles of translational medicine. In anticipation of the Company's growth plans, Denali Therapeutics is...

  • Facilities Coordinator

    vor 1 Woche

    Zurich, Schweiz JLL Vollzeit

    About JLL - We’re JLL—a leading professional services and investment management firm specializing in real estate. We have operations in over 80 countries and a workforce of over 91,000 individuals around the world who help real estate owners, occupiers and investors achieve their business ambitions. As a global Fortune 500 company, we also have an...

  • Export Coordinator

    Vor 6 Tagen

    Zurich, Schweiz HUBER+SUHNER Vollzeit

    Every second our fiber optic and electrical systems connect societies, companies and individuals, all around the world. **Export Coordinator**: **m/w/d** | **Pfäffikon (ZH)** | **100 %** | **Unbefristet** **Ihr Aufgabengebiet**: Unser Team Order Fulfillment, welches dem Segment Transportation im Bereich Low Frequency angehört, ist die zentrale...

  • Business Operations Manager

    vor 7 Monaten

    Zurich, Schweiz Experis Switzerland Vollzeit

    Experis Switzerland Zurich, SwitzerlandPosted 7 minutes ago Flexible Contract Negotiable Business Operations Coordinator A very well-known IT company is looking for a Business Operations Manager. Location: Zurich Duration: 18 months As an Operations Manager / Coordinator, you will play a pivotal role in ensuring the seamless functioning of the marketing...

  • Clinical Research Associate Ii

    Vor 6 Tagen

    Zurich, Schweiz Clinipace Vollzeit

    **Job Title**:Clinical Research Associate II **Job Location**:Zurich, Switzerland (Home-based in Switzerland) **Job Overview**: **Job Duties and Responsibilities**: - Provides support to Project Team and Clinical Operations Team. - Maintains working knowledge of protocols and Monitoring Plans for assigned projects. - Demonstrates strong written and verbal...

  • Clinical Research Associate Ii

    Vor 2 Tagen

    Zurich, Schweiz Clinipace Vollzeit

    **Job Title**:Clinical Research Associate II **Job Location**:Zurich, Switzerland (Home-based in Switzerland)** **Job Overview**: **Job Duties and Responsibilities**: - Provides support to Project Team and Clinical Operations Team. - Maintains working knowledge of protocols and Monitoring Plans for assigned projects. - Demonstrates strong written and...

  • Contract Coordinator

    vor 12 Stunden

    Zurich, Schweiz EF Education First Vollzeit

    Position: Contract coordinator The Contract Coordinator will be a part of a team whose goal is to help source and contract with applicants for our online teaching platform. On our small team, flexibility and entrepreneurial spirit are key - priorities constantly change, and our goals are ambitious. If you are always ready to roll up your sleeves and do...

  • People & Office Coordinator

    vor 7 Monaten

    Zurich, Schweiz BIG (Bjarke Ingels Group) Vollzeit

    **Job Area**: People**Application Deadline**: As soon as possible**Location**: Zurich **Join BIG!** BIG is a group of 700+ architects, engineers, urbanists, inventors, researchers and business minds from all over the world who are based in our Copenhagen, New York, London and Barcelona offices. Our built work ranges from the most diverse urban playground...