Study Start-up Manager

vor 6 Monaten

Rotkreuz, Schweiz Novartis Vollzeit

**Summary**:
The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team.

**About the Role**:
**Your responsibilities include, but are not limited to**:

- Supports and collaborates with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio in country SSU strategy and global study team to ensure SSU timelines and deliverables are met according to country commitment
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable and also ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms
- Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders as well as reportable events and notifications to IRB/IEC and Health Authorities as applicable
- Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness and ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- Implements innovative and efficient processes which are in line with Novartis strategy and supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.
- Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned and in satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
- Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light” and oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
- Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required and leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead

**Required Experience & Qualifications**:

- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
- Fluent in both written and spoken English and German
- Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills and communicates effectively in a local/global matrixed environment

**Commitment to Diversity and Inclusion**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Division

Development

Business Unit

Pharmaceuticals

Location

Switzerland

Site

Rotkreuz (Office-Based)

Company / Legal Entity

C018 (FCRS = CH018) Novartis Pharma Schweiz AG

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regulär

Shift Work

No

  • Global Study Lead

    Vor 7 Tagen

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Global Study Lead. **Background**: The Global Study Lead for Investigator Initiated Studies is responsible for ensuring that all studies are evaluated, overseen, closed out and documented in an appropriate manner within the planned...

  • Global Study Lead

    vor 3 Wochen

    Rotkreuz, Schweiz F. Hoffmann-La Roche AG Vollzeit

    Global Study Lead - Diagnostics (m/f/d)Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a...

  • Global Study Lead

    vor 3 Wochen

    Rotkreuz, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Global Study Lead

    vor 24 Stunden

    Rotkreuz, Schweiz Work Selection Vollzeit

    For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Global Study Lead for one year with option for extension.he Global Study Lead for Investigator Initiated Studies is responsible for ensuring that all studies are evaluated, overseen, closed out and documented in an appropriate...

  • Global Study Lead

    vor 3 Stunden

    Rotkreuz, Schweiz Work Selection Vollzeit

    For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Global Study Lead for one year with option for extension.he Global Study Lead for Investigator Initiated Studies is responsible for ensuring that all studies are evaluated, overseen, closed out and documented in an appropriate...

  • Global Study Lead

    Vor 4 Tagen

    Rotkreuz, Schweiz Work Selection Vollzeit

    For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Global Study Lead for one year with option for extension.he Global Study Lead for Investigator Initiated Studies is responsible for ensuring that all studies are evaluated, overseen, closed out and documented in an appropriate...

  • Clinical Contract Manager

    vor 2 Wochen

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Clinical Contract Manager (M/F/d) **Background**: **Tasks & Responsibilities**: - The CDMA Contract Manager proactively drives the process and continuous improvement of all contractual agreements across CDMA, including facilitation of...

  • International Product Manager

    vor 3 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **International Product Manager (M/F/d) - customer insights / In Vitro Diagnostics products / pharmaceuticals development / complex matrix environment / senior leadership interactions/ Result driven /Agile / English** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified International...

  • Digital Marketing Manager

    Vor 7 Tagen

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Project**: For our customer Roche Diagnostics Schweiz AG based in Rotkreuz we are looking for a qualified Digital Marketing Manager (M/F/d) **Background**: The Digital Marketing Manager oversees the strategic planning, development, and coordination of the digital marketing strategy, execution, and optimization to promote the sale of regulated IVD products...

  • Clinical Contract Manager

    vor 2 Wochen

    Risch-Rotkreuz, Schweiz FLEXSIS Vollzeit

    INTRODUCTION: Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting. For our client Roche Diagnostics in Rotkreuz we are looking for a reliable Clinical Contract Manager The...

  • Clinical Contract Manager

    vor 1 Woche

    Risch-Rotkreuz, Schweiz Flexsis Vollzeit

    Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.For our client Roche Diagnostics in Rotkreuz, we are looking for a reliable Clinical Contract Manager.The perfect...

  • Solution Manager

    vor 2 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Solution Manager **Background**: Within the „RDS Marketing & Customer Insights“ team, the „Customer Experience & Solution Design“ chapter aims to elevate and scale customer experience across Diagnostics to further differentiate...

  • International Product Manager

    vor 1 Monat

    Rotkreuz, Schweiz ITech Consult Vollzeit

    International Product Manager (m/f/d) – Customer Insights / In Vitro Diagnostics Products / Pharmaceuticals Development / Complex Matrix Environment / Senior Leadership Interactions / Result Driven / Agile / English Project:For our customer Roche Diagnostics International AG based in Rotkreuz, we are looking for a highly qualified International Product...

  • Clinical Development Leader

    vor 2 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Clinical Development Leader (M/F/d) - Neuroscience /** **Neurology /** **IVDR/FDA / Clinical study Design/ Clinical Science /** **Agile / English** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Clinical Development Leader (M/F/d). **Background**: Within Clinical Development...

  • International Product Manager in Personalized

    vor 6 Monaten

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated **International Product Manager in Personalized Healthcare Solutions** for one year with option for extension. Roche Diagnostics International Ltd in Rotkreuz is one of the world’s leading providers of...

  • Clinical Development Leader

    vor 2 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    Clinical Development Leader (m/f/d) – Neuroscience / Neurology / IVDR/FDA / Clinical study Design/ Clinical Science / Agile / English Project:For our customer Roche Diagnostics International AG based in Rotkreuz, we are looking for a highly qualified Clinical Development Leader (m/f/d). Background: Within Clinical Development, clinical expertise and...

  • Solution Manager

    vor 1 Monat

    Rotkreuz, Schweiz ITech Consult Vollzeit

    Project:For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Solution Manager. Background:Within the „RDS Marketing & Customer Insights“ team, the „Customer Experience & Solution Design“ chapter aims to elevate and scale customer experience across Diagnostics to further differentiate from...

  • Clinical Research Associate

    vor 5 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Clinical Research Associate I (M/F/d) GCP / FDA / IVD directives / clinical studies / English** **Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Clinical Research Associate I (M/F/d)** **Background**: The Clinical Research Associate will design, plan, coordinate, and conduct all activities...

  • Product Manager

    vor 3 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Product Manager in the Core Lab Reagents Lifecycle Team (M/F/d) - Medtech / Pharma/biotech / IVD market / commercialization / Stakeholder management /Agile / English** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Product Manager in the Core Lab Reagents Lifecycle Team...

  • Training Manager

    vor 1 Monat

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Training Manager **Background**: The Training Management team is part of the Compliance Support at the Diagnostic Operations Rotkreuz and is responsible for implementing the training process in the global Learning Management System...