Clinical Study Manager, Early Phase, Pharma

Vor 5 Tagen

Baden, Schweiz CTC Resourcing Solutions Vollzeit

**_The Life Science Career Network_**

Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms.

For the next possible date we are looking for a Clinical Study Manager to step in a permanent position.

**Clinical Study Manager (f/m/d)**

**Responsibilities**:

- Implement and execute to a high standard all aspects of assigned clinical studies from designing and planning through to conducting and reporting
- Oversee and manage the day-to-day clinical trial activities internally, as well as externally with the CRO, vendors and external partners to monitor progress, timelines, and budget, and ensure study execution is of high quality
- Lead clinical trial team meetings with the CRO/vendor, proactively identify and manage risks, and ensure study deliverables (timelines, milestones, etc.) are on track and of good quality
- Manage, oversee, and build effective relationships with external vendors (e.g. CROs and other third party vendors) to ensure adequate service provision in clinical trial execution; this includes the evaluation, auditing, comparison of cost proposals and final selection of service providers
- Oversee performance of CROs and other third-party vendors, to ensure compliance with the protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate as appropriate
- Oversee the management of clinical trial sites during the planning and execution of the trial: prepare training materials, train sites, ensure ongoing adherence to clinical study protocol and procedures, perform ongoing study staff training (e.g. site initiation visits, ongoing training)
- Identify potential sites and investigators, oversee site qualification to ensure suitability and readiness of investigators and trial sites
- Review clinical trial documents (e.g. protocols, amendments, protocol information sheet / informed consent forms, Investigator Brochures, DSURs, clinical study reports, publications) in collaboration with the medical monitor and other members of the clinical development team; and review/approve study related documents (e.g. eCRF, cohort management plans, and clinical monitoring plans)
- Develop supportive documents such as pharmacy manuals, lab manuals, study worksheets and/or other documents needed for trial execution, and coordinate input from team members
- Support budget planning and management of assigned clinical trial(s) and/or work packages
- Review and approve invoices from sites, CROs and other service providers for work completed and prepare accruals

**Requirements**:

- University degree in life sciences or a healthcare related field, Master Degree or Ph. D. will be preferred
- At least 2-3 years of experience in clinical trial management, ideally on international/global level
- Experience in Early phase (I-II) drug development
- Background and experience in Oncology will be preferred
- Experience in cell therapy studies will be preferred
- In depth experience with study planning, site feasibility, study conduct and close-out, database lock through generation of the clinical study report (CSR)
- Experience in CRO and third-party vendor oversight and management
- Deep knowledge of design, set-up and conduct of clinical studies
- Profound knowledge of GCP and international regulations governing the conduct of clinical trials
- Stakeholder / relationship and leadership management experience
- Excellent and effective communication (both written and oral) and presentation skills
- Fluency in English (written and oral) is obligatory

  • Non-core Country Manager

    vor 2 Wochen

    Baden, Schweiz Johnson & Johnson Vollzeit

    **Non-Core Country Manager (NCCM) (Global Clinical Operations)**: Who is Janssen? We're more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. Our mission is to transform individual lives and fundamentally change the way diseases are handled, interpreted, and prevented. We believe...

  • Studienkoordinator / Studienkoordinatorin (Study

    Vor 5 Tagen

    Baden, Schweiz Kantonsspital Baden Vollzeit

    Wir suchen per sofort oder nach Vereinbarung eine/n Studienkoordinator / Studienkoordinatorin (Study Nurse) 60-80%.**Deine Aufgaben**: - Selbständige Betreuung von klinischen Studien - Planung, Koordination und Durchführung von Patientenvisiten - Entnahme, Verarbeitung und Versand von Blutproben - Erhebung und Eingabe studienspezifischer Daten in...

  • Studienkoordinator / Studienkoordinatorin (Study

    Vor 5 Tagen

    Baden, Schweiz Kantonsspital Baden Vollzeit

    Wir suchen per 01. Dezember oder nach Vereinbarung eine/n Studienkoordinator / Studienkoordinatorin (Study Coordinator) 80-100%.**Deine Aufgaben**: - Selbständige Betreuung klinischer Studien in Zusammenarbeit mit dem lokalen Studienverantwortlichen und dem Sponsor - Planung, Koordination und Durchführung von Patientenvisiten - Planung, Koordination und...

  • Studienkoordinator/in (Study Nurses) Mit

    vor 2 Wochen

    Baden, Schweiz Kantonsspital Baden Vollzeit

    **Ihre Aufgaben**: - Selbständige Betreuung von klinischen Studien mit Schwerpunkt auf einem Innosuisse Projekt - Planung, Koordination und Durchführung von Patientenvisiten - Entnahme, Verarbeitung und Versand von Blutproben - Erhebung und Eingabe studienspezifischer Daten in Datenbanken - Administrative Unterstützung bei der Bearbeitung von...

  • Project Commissioning and Construction Manager

    vor 1 Woche

    Baden, Schweiz Hitachi Energy Ltd Vollzeit

    **Description** **At Hitachi Energy our purpose is advancing a sustainable energy future for all. We bring power to our homes, schools, hospitals and factories. Join us and work with fantastic people, while learning and developing yourself on projects that have a real impact to our communities and society. Bring your passion, bring your energy, and be part...

  • Studienkoordinatorin (Study Nurse) 40% Befristet

    vor 4 Wochen

    Baden, Schweiz Kantonsspital Baden Vollzeit

    **Ihre Aufgaben**: - Selbständige Betreuung der klinischen Studie in Zusammenarbeit mit dem lokalen Studienverantwortlichen und dem Auftraggeber - Planung, Koordination und Durchführung von Patientenvisiten - Entnahme, Verarbeitung und Versand von Blutproben - Erhebung und Eingabe studienspezifischer Daten in Datenbanken - Administrative Unterstützung...

  • Is Project Manager ERP Transformation

    vor 2 Wochen

    Baden, Schweiz Accelleron Vollzeit

    At Accelleron, we go further. Building on the heritage of more than 100 years as ABB Turbocharging, you will join a team of true experts in an exciting international environment that share a commitment to excel, to be a trusted partner in supporting our customers in the gradual change towards sustainable industries with innovative technology, expertise and...

  • Customer Operations

    vor 4 Wochen

    Baden, Schweiz Ascendis Pharma Vollzeit

    To develop marketing strategies, using all elements of the marketing mix, including brand development with the aim of increasing sales.AREAS OF IMPACT :Working with the Country Managers to create and track in-country marketing and brand plans and to communicate to the commercial organisation as appropriate.Ensuring promotional campaigns within agreed...

  • Studienkoordinatorin (Study Nurse) 40% (All Genders)

    Vor 6 Tagen

    Baden, Schweiz Kantonsspital Baden Vollzeit

    **Ihre Aufgaben**: - Selbständige Betreuung der klinischen Studie in Zusammenarbeit mit dem lokalen Studienverantwortlichen und dem Auftraggeber - Planung, Koordination und Durchführung von Patientenvisiten - Entnahme, Verarbeitung und Versand von Blutproben - Erhebung und Eingabe studienspezifischer Daten in Datenbanken - Administrative Unterstützung...

  • Associate Project Manager

    vor 1 Woche

    Baden, Schweiz ABB Vollzeit

    **Associate Project Manager (80 - 100%)**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • IS Project Manager SAP Transformation

    vor 4 Wochen

    Baden, Schweiz Accelleron Vollzeit

    IS Project Manager SAP Transformation (80-100%) (m/f/d)Apply locations CHE Baden time type Full time posted on Posted 27 Days Ago job requisition id JR100963At Accelleron, we go further. Building on the heritage of more than 100 years as ABB Turbocharging, you will join a team of true experts in an exciting international environment that share a commitment...

  • Product Life Cycle Manager

    Vor 4 Tagen

    Baden, Schweiz Accelleron Vollzeit

    As Life Cycle Manager you are responsible for overseeing the Product Lifecycle Management system and related processes. You will ensure a streamlined Service product portfolio which is aligned with and adequately supports the business for lifecycle and change management to drive operational excellence. In this position, you will report to the Head of...

  • Sr Engineering Manager

    vor 1 Woche

    Baden, Schweiz GE Gas Power Vollzeit

    **Job Description Summary**: This role will be responsible to manage the Arrangement & Piping Operations and HRSG Operations and enable the engineering team to deliver on its Priorities and Key Performance Indicators year over year, ensuring the team delivers efficient, high-quality services to its customers. The Operations Leader will define the operating...

  • Trade & Transportation Manager (80-100%)

    vor 2 Wochen

    Baden, Schweiz ABB Vollzeit

    **Trade & Transportation Manager (80-100%)**: **Machen Sie den nächsten Karriereschritt bei ABB: Treiben Sie in einem globalen Team die Transformation von Gesellschaft und Industrie in eine produktivere und nachhaltigere Zukunft voran. Bei ABB fördern wir Vielfalt und Inklusion in allen Bereichen - ob Alter, Geschlecht, Sexualität, Ethnie, ob mit oder...

  • Senior SAP Service Delivery Manager

    vor 3 Wochen

    Baden, Schweiz Aveniq AG Vollzeit

    Du willst beim Thema Service Delivery Management, Digitalisierung und Neugestaltung von Prozessen mitmischen? «Challenge accepted»? Dann bewirb dich. Wir freuen uns sehr!Was dich erwartetDu bist für die Festlegung und Überwachung der SLA «deiner» Kunden im Bereich der SAP-Basis- und Applikationsleistungen verantwortlich.Du überwachst das vereinbarte...

  • Heimärztin / Heimarzt

    Vor 2 Tagen

    Baden AG, Aargau, Schweiz Clienia AG Vollzeit

    Senior Electrical Engineer in Digital Health Technologies for the Development of Brain Imaging SoftwareOptohive is developing brain imaging technology and is a future ETH startup, hosted by the Rehabilitation Engineering Lab (RELab) at the Department of Health Sciences and Technology at ETH Zurich.The RELab is an interdisciplinary group with competencies in...

  • Senior Manager für SAP-Basis- und

    Vor 4 Tagen

    Baden AG, Aargau, Schweiz Aveniq AG Vollzeit

    Das UnternehmenAveniq AG ist ein innovatives Unternehmen, das sich auf die Entwicklung von Lösungen für das Service Delivery Management spezialisiert hat. Wir bieten eine Vielzahl von Dienstleistungen an, von der Beratung bis hin zur Implementierung von SAP-Lösungen.Ihr AufgabenbereichAls Senior Manager sind Sie verantwortlich für die Gestaltung und...

  • Commisioning Manager

    vor 2 Wochen

    Baden, Schweiz GE Gas Power Vollzeit

    **Job Description Summary**: Join our team as a Commissioning Manager. The Commissioning Manager plays an instrumental role during the commissioning phase of the project. In this capacity you are in-charge of the complete execution of commissioning activities onsite from quality standard and plan, time schedule, major packages hand over from Erection to...

  • Regional General Manager, Digital

    Vor 6 Tagen

    Baden, Schweiz ABB Vollzeit

    **Regional General Manager, Digital - Europe**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • Global Product Manager

    vor 2 Wochen

    Baden, Schweiz ABB Vollzeit

    **Global Product Manager - Remote Assistance Services**:** Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and...