Director, Clinical Monitoring

vor 2 Wochen


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_



  • Zug, Schweiz Seagen Vollzeit

    Position Summary: The Director, Regional Clinical Trial Operations is a critical role responsible for leading the Regional Clinical Trial Operations (RCTO) team in trial execution of all trials within a molecule or therapeutic area and in helping build the strategic vision of the European team. This position will take a primary role in providing leadership...

  • Clinical Research Associate II.

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz PSI Vollzeit

    Job Description As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will: Conduct and report all types of onsite monitoring visits Be involved in study startup and feasibility research ...


  • Zug, Schweiz Urovant Sciences Vollzeit

    **About Us** Urovant Sciences 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...

  • Director, Publications

    vor 20 Stunden


    Zug, Schweiz GSK Vollzeit

    **Site Name**: USA - Pennsylvania - Philadelphia, Switzerland - Zug, UK - London **Posted Date**: Feb 7 2024 The Director, Publications will lead the establishment of a Strategic Publication Plan in alignment with Global Medical Plans, medical/scientific communication strategy and objectives. In addition, the Global Publications Director will ensure that...


  • Zug, Schweiz GSK Vollzeit

    **Site Name**: UK - London - Brentford, Baar Onyx, Switzerland - Zug, USA - Pennsylvania - Upper Providence **Posted Date**: Apr 4 2024 **Medical Director, Global Medical Affairs - Hematology**: The Global Medical Director role is a unique opportunity for an experienced, innovative, and proactive medical professional to facilitate the understanding of the...

  • Medical Monitor

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz PSI Vollzeit

    Job Description PSI Medical Monitors  provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in the United States Responsibilities: Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party...

  • Medical Monitor

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz PSI Vollzeit

    Job Description PSI Medical Monitors  provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Canada.  Responsibilities: Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on...

  • Director, Quality Management.

    Gefunden in: Talent CH C2 - vor 1 Woche


    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...

  • Associate Medical Writer.

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz PSI Vollzeit

    Job Description Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives Collects and tracks documents for CSR appendices, in support of the Quality Control...

  • Director, Therapeutic Strategy.

    Gefunden in: Talent CH C2 - vor 3 Stunden


    Zug, Schweiz PSI Vollzeit

    Job Description Therapeutic Oversight Is involved in indication-specific strategy planning and implementation across the assigned therapeutic area Develops best practices based on lessons learned Mentors, trains, and assists Operations staff in strategies and best practices within their assigned therapeutic area Participates in external executive...


  • Zug, Schweiz Seagen Vollzeit

    Position Summary: The Regulatory Affairs Associate Manager will report to and support the Regulatory Affairs Director/Associate Director by leading the preparation and submissions of regulatory dossiers to European and Swiss competent authorities, in line with the global regulatory plan for one or more Oncology products. Principal Responsibilities: -...

  • Lead Data Manager.

    Gefunden in: Talent CH C2 - Vor 6 Tagen


    Zug, Schweiz PSI Vollzeit

    Job Description The Lead Data Manager is responsible for all data management activities in assigned clinical trials under supervision. Acts as primary communication point for project teams and company departments regarding clinical data management Acts as primary communication point for clients/vendors for all data management aspects of clinical...


  • Zug, Schweiz SHL Medical AG Vollzeit

    **Job Overview** The position of the Director global Quality of SHL Medical AG holds overall responsibility for compliance to all applicable regulations pertaining to all operations functioning on the assigned site as well as corporate compliance to all applicable regulations including cGMP pertaining to all the markets currently being served by the...

  • KEY ACCOUNT DIRECTOR

    Gefunden in: Talent CH C2 - vor 2 Wochen


    Zug, Schweiz IQVIA Vollzeit

    Life Science HQs (Switzerland) At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The unique portfolio of analytics, consulting, data, technology solutions, and commercial services we provide to the life sciences industry is made...

  • Legal Director

    Vor 3 Tagen


    Zug, Schweiz MET Group Vollzeit

    Company Description **MET Group **is an integrated European energy company, headquartered in Switzerland, with activities in natural gas and power, focused on multi-commodity wholesale, trading and sales, as well as energy infrastructure and industrial assets. **MET Group **is represented in 13 European countries, with 700+ permanent staff in France,...

  • Legal Director

    vor 19 Stunden


    Zug, Schweiz MET Group Vollzeit

    Company Description **MET Group **is an integrated European energy company, headquartered in Switzerland, with activities in natural gas and power, focused on multi-commodity wholesale, trading and sales, as well as energy infrastructure and industrial assets. **MET Group **is represented in 13 European countries, with 700+ permanent staff in France,...


  • Zug, Schweiz ITech Consult Vollzeit

    **International Product Manager Point-of-Care (f/m/d) - Medical Device /Marketing / product & customer segment strategy Management / solution-oriented mindset / adapt to change / English** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified International Product Manager Point-of-Care...

  • Sales Director of Engineering Services

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz Daxx Vollzeit

    Key Responsibilities: ・Responsible for expanding Grid Dynamics’ business across DACH region, own the P&L responsibilities for new logo acquisition. ・Responsible for focused Go-To-Market strategy to drive sustained demand, accelerate growth and increase territory/regional revenue. ・Build a sizable pipeline of qualified digital engineering...

  • Regional Communications Senior Specialist

    Gefunden in: Talent CH C2 - vor 1 Woche


    Zug, Schweiz SHL Group Vollzeit

    Job Overview The Senior Specialist in Regional Communications, you are responsible for internal and external communications, public relations, and internal/external events at SHL within the specified region. The Senior Specialist in Regional Communications will create and nurture a positive public image and reputation of SHL and represent our interests...