Clinical Operations Manager
vor 14 Stunden
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 program(s), supporting clinical strategy defined in Clinical Development Plan.
- Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
- Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
**ACCOUNTABILITIES**:
- Accountable for planning and operational strategy and execution for assigned clinical trials
Challenges study team to ensure operational feasibility, inclusive of patient and site burden
- Validates budget and ensures impacts are adequately addressed
- Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
- Challenges study team to ensure timelines meet the needs of the clinical development plan
- Ensure new team members and vendors are appropriately onboarded
- During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
- Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
- Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
- Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;
- Specific areas of sponsor oversight include, but are not limited to:
- Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
- Review and endorsement of relevant study plans, as applicable
- Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes
- Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
- Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
- In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
- Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.
- Represent the Clinical Operations Manager role in functional initiatives or working groups.
- Help with onboarding and mentoring of new or junior COMs.
**EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS**:
- Bachelor’s Degree or international equivalent required, Life Sciences preferred.
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Excellent communication skills and stakeholder management
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Fluent business English (oral and written)
- Experience in conducting non-interventional studies is preferred
- 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management. Experience should include non-interventional, post-approval studies. Experience in more than one therapeutic area is advantageous.
**WHAT TAKEDA CAN OFFER YOU**
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-chang
-
Clinical Trial Manager
Vor 7 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...
-
Clinical Trial Manager
Vor 4 Tagen
Zurich, Schweiz Numab Therapeutics AG VollzeitNumab 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 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...
-
Clinical Evaluation Manager
vor 1 Woche
Zurich, Schweiz Proclinical VollzeitProclinical are recruiting a Clinical Evaluation Manager for a medical technology devices organisation on a permanent basis. As a Clinical Evaluation Manager, you will be handling the development of clinical strategies and submission documentation for first in ma, regulatory submission and post market trials for their class III...
-
Clinical Project Manager
vor 7 Monaten
Zurich, Schweiz SIVA Health AG VollzeitSIVA 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 Affairs Manager
vor 7 Monaten
Zurich, Schweiz Sonova VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Clinical Affairs Manager
vor 7 Monaten
Zurich, Schweiz Sonova AG VollzeitWho we are In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced...
-
Clinical Studies Manager
vor 6 Monaten
Zurich, Schweiz Sonova VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Clinical Studies Manager
vor 6 Monaten
Zurich, Schweiz Sonova AG VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Clinical Affairs Manager
Vor 2 Tagen
Zurich, Schweiz Sonova VollzeitWho we are In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Hansaton, Advanced...
-
Clinical Operation Manager:in
Vor 7 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 VollzeitWe 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...
-
Clinical Evaluation Expert
vor 7 Monaten
Zurich, Schweiz Klenico Health VollzeitKlenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness. In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders. We are...
-
Clinical Research Associate Ii
Vor 7 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...
-
Clinical Trial Associate
vor 2 Wochen
Zurich, Schweiz Proclinical VollzeitA leading Immunology company are recruiting for an experienced Clinical Trial Assistant to join their growing team on a 6 month contract with option to become a permanent employee after the initial assignment. This is a great opportunity to join a busy clinical team working across a variety of highly complex trials whilst taking on a wide range of...
-
Zurich, Schweiz Veeva Systems VollzeitVeeva 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...
-
Medical Information Operations Manager
Vor 7 Tagen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**Job Overview**: - Support and lead operational development, implementation and maintenance of Global Medical Information (GMI) processes and related procedural and guidance documents in EMEA region - Ensure adherence and compliance to GMI processes in EMEA region - Support the GMI participation in internal or 3rd party audits impacting EMEA Medical...
-
Hq Manager
vor 1 Woche
Zurich, Schweiz European Academy of Allergy and Clinical Immunology (EAACI) VollzeitThe European Academy of Allergy and Clinical Immunology (EAACI) is an association of clinicians, researchers and allied health professionals, dedicated to improving the health of people affected by allergic diseases. With more than 14,000 members from 125 countries and over 50 National Allergy Societies, EAACI is the primary source of expertise in Europe...
-
Sales Operations Manager
vor 7 Monaten
Zurich, Schweiz Orange VollzeitKey Accountabilities: Manage all aspects of Sales operations activities, including sales performance and associated KPI, sales compensation, planning cycles together with Finance, reporting and analysis, and special projects. In details: - Support Sales Manager / Country Manager to drive efficiently their organization with, pipeline and order evolution and...
