Director, Clinical Monitoring

vor 17 Stunden

Zug, Schweiz Urovant Sciences GmbH Vollzeit

**Position Description**:
**Primary Responsibilities**:

- The Director, Clinical Monitoring will be responsible for all aspects of monitoring and site management oversight for all of Urovant's CRO partners. He/she will work closely with Urovant's Clinical Operations Leads, Data Management, and QA, as well as with all involved functions and vendors (such as Contract Research Organizations [CROs]).
- She/he will act as the primary contact within Urovant for all aspects of monitoring and site management and will contribute to the preparation of study plans with the respective CROs, development and measurement of monitoring key performance indicators, ensuring delivery of quality operational results, and will be involved with the selection and oversight of applicable Clinical Operations vendors.
- She/he will be responsible to ensure consistency of process and approaches across global monitoring on all Urovant trials, and will work directly with the CRO monitoring organizations on ensuring quality monitoring deliverables through monitoring report review, observational visits, identification/mitigation of monitoring issues and compliance to study plans
- Working within the Clinical Operations organization, Director/Senior Director Global Clinical Monitoring will collaborate with Clinical Operations Leads, Clinical Development and/or Medical Affairs, Project Managers, and Finance on budgets related to monitoring oversight activities on assigned studies
- The Director/Senior Director Global Clinical Monitoring may mentor or supervise other employees or contractors within the Clinical Operations Team
- The Director/Senior Director Global Clinical Monitoring may develop/contribute to process development/improvement within Urovant in Clinical Operations, R&D, in Europe, as well as at the company level.

**Education and Experience**:

- Health or Biological Science degree required; BS or MS preferred.
- At least 10 years of experience in clinical monitoring, with at least 5 years of experience in global clinical trials, directly managing monitoring.
- Experience in monitoring all phases of clinical trials required.
- Previous experience at a sponsor/pharmaceutical company preferred.

**Essential Skills and Abilities**:

- Demonstrates leadership capabilities in cross functional teams.
- Good organizational skills.
- Good verbal and written communication skills.
- Good presentation skills.
- International travel required.
- Ability to work across locations and time zones.
- Ability to work on multiple projects and assignments at the same time.
- Ability to prioritize tasks.
- Strong financial business acumen and analytical skills.
- Strong interpersonal skills and ability to manage multiple vendors.
- #LI-hybrid_

  • Director, Clinical Monitoring

    vor 17 Stunden

    Zug, Schweiz Urovant Sciences Vollzeit

    **About Us** Urovant Sciences, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions beginning with overactive bladder. Our lead product, GEMTESA®(vibegron), is an oral, once-daily tablet for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary...

  • Associate Director

    Vor 4 Tagen

    Zug, Schweiz NonStop Consulting Vollzeit

    If you are currently performing the role for a Clinical Trial Manager or Clinical Operations Manager and looking to step into a Director position this is your chance! My Client who is an international company is looking for a Associate Director - Clinical Operations to join their team in the office in Zug, Switzerland on a 12 month contract. They are focused...

  • Clinical Operations Director

    Vor 4 Tagen

    Zug, Schweiz NonStop Consulting Vollzeit

    My Client who is an international company is looking for a Clinical Operations Director to join their team in the office in Zug, Switzerland on a 12 month contract. They are focused on small molecules and are moving to biotech meaning the work will be very specific and allow for unique collaborations! Given they have a global team it is a dynamic and...

  • Sr. Clinical Project Manager/associate Director

    vor 17 Stunden

    Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    The Senior Clinical Project Manager/Associate Director, Clinical Operations will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the...

  • Director Clinical Scientist

    Vor 4 Tagen

    Zug, Schweiz GlaxoSmithKline Vollzeit

    Site Name: UK - Hertfordshire - Stevenage, GSK HQ, Upper Providence, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53, Zug HousePosted Date: Dec 4 2024Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you!As...

  • Director Clinical Scientist

    Vor 3 Tagen

    Zug, Schweiz GSK Vollzeit

    Site Name: UK - Hertfordshire - Stevenage, GSK HQ, Upper Providence, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53, Zug HousePosted Date: Dec 4 2024Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you!As...

  • Associate Director, Study Start Up

    Vor 2 Tagen

    Zug, Schweiz Seagen Vollzeit

    Position Summary: - Up, to define vision, goals, strategies and tactics to ensure delivery of study start-up activities per project plans across the portfolio. The Associate Director will lead and a team of SSU managers to drive site activation delivery focused on quality, efficiency and expediency. This role is responsible for performance management of...

  • Director Clinical Pharmacology Lifecycle Management

    Vor 4 Tagen

    Zug, Schweiz GlaxoSmithKline Vollzeit

    Site Name: UK - London, Belgium, Switzerland - Zug, Upper Merion, Upper ProvidencePosted Date: Dec 19 2024A fantastic opportunity is available within GSK's Clinical Pharmacology Lifecycle Management team for an experienced individual who will provide clinical pharmacology, therapeutic, and regulatory support for GSK portfolio.You will ensure optimal...

  • Director, Medical Monitor

    Vor 6 Tagen

    Zug, Schweiz Seagen Vollzeit

    Position Summary: Principal Responsibilities: - Establish and drive teams to execute the strategic long-term vision for the program - Lead clinical study teams and ensure appropriate medical monitoring for ongoing clinical studies - Lead development and maintenance of clinical documents (e.g. protocols and amendments, investigator brochures, clinical study...

  • Lead Clinical Research Associate.

    vor 5 Stunden

    Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:ResponsibilitiesCoordinates investigator/site feasibility and identification process, as well as study startup.Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.Reviews monitoring visit reports for all visit types and ensures reporting compliance of the...

  • Lead Clinical Research Associate.

    vor 9 Minuten

    Zug, Schweiz PSI Vollzeit

    Job Description Coordinates investigator/ site feasibility and identification process, as well as study startup. Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. Manages...

  • Local Clinical Operations Manager

    vor 17 Stunden

    Zug, Schweiz Johnson & Johnson Vollzeit

    Local Clinical Operations Manager - Schweiz (für Global Clinical Operations Janssen D-A-CH) Über Johnson & Johnson - Janssen Seit über 130 Jahren gehören Diversity, Equity & Inclusion (DEI) zu unserer Unternehmenskultur bei Johnson & Johnson. Sie sind ein Grundprinzip unseres täglichen Handelns. Die Würde und Vielfalt aller Menschen zu respektieren,...

  • Director, Quality

    vor 17 Stunden

    Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    Reporting to the Executive Director, Quality, as functional manager and to the Vice President, GM Zug, as disciplinary manager. The Director, Quality, is responsible for creating, monitoring, and maintaining phase-appropriate levels of compliance at Kiniksa’s CDMOs, partners and internal operations related to selected clinical and commercial...

  • Clinical Sciences Program Lead

    Vor 7 Tagen

    Zug, Schweiz GSK Vollzeit

    **Site Name**: UK - London - New Oxford Street, Stevenage, USA - Pennsylvania - Upper Providence, Waltham, Zug House **Posted Date**: Jan 17 2025 - Are you energized by a highly visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the_**_ Clinical Sciences Program Lead_**_ role could be an exciting opportunity...

  • Executive Director, Heor

    vor 17 Stunden

    Zug, Schweiz Urovant Sciences GmbH Vollzeit

    **Position Description**: The Executive Director Health Economics & Outcomes Research (HEOR) and Research and Development (R&D) International will develop the strategy and provide the internal expertise, guidance and oversight to the design, methodologies, analytic techniques and reporting of heath economic research and outcomes (HEOR). This will include...

  • Clinical Research Associate, 100%

    vor 1 Woche

    Zug, Schweiz Implantica Vollzeit

    **About Implantica Group Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica’s lead product, RefluxStop, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also...

  • Clinical Project Physician

    vor 8 Stunden

    Zug, Schweiz TN Switzerland Vollzeit

    Clinical Project Physician (Rheumatology/Autoimmune) – Based Anywhere in Europe (m/w/d)Client: ViatrisLocation: ZugJob Category: OtherJob Reference: 1c8881bda3a6Job Views: 15Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source...

  • Director, Quality Management.

    vor 6 Stunden

    Zug, Schweiz TN Switzerland Vollzeit

    Social Network You Want to Login/Join With:Facilitation of professional development and career advancement of Quality Management staffAdministrative supervision of Quality Management staff, jointly with Senior Director Quality ManagementParticipation in recruitment of Quality Management (QM) staffFacilitation of initial and ongoing training of Quality...

  • Clinical Project Physician

    vor 2 Stunden

    Zug, Schweiz Viatris Vollzeit

    Cenetogrel LLC At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of...

  • Director, Quality Management.

    vor 1 Stunde

    Zug, Schweiz PSI Vollzeit

    Job Description Resource Management and Training: Participation in QM resource allocation Resource allocation of QA auditors Facilitation of professional development and career advancement of Quality Management staff Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management Participation in...