Clinical Trial Manager
vor 2 Wochen
Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Summary:
The Clinical Trial Manager is the Regional or Global Protocol Lead in Regional Clinical Trial Operations (RCTO) responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones.
Requirements or Responsibilities:
- Act as Global or Regional Protocol Lead. Serve as main point of contact for clinical site management.
- May have dotted line oversight of Functional Service Provider resources.
- May act as mentor for less senior RCTO staff on the study.
- Participate as the main point of contact for RCTO on the Clinical Study Team.
- Supports Molecule Lead. Closely collaborates with internal study team members, Contract Research Organizations, vendors or sites.
- Monitors metrics to drive on-time delivery of clinical trial milestones.
- Assist with creation and review of protocols/ICFs and clinical trial documents.
- Lead in identification, evaluation, and selection of clinical trial sites.
- Coordinate and manage vendor processes. May contribute to vendor selection.
- Facilitate communication between sites and Seagen cross-functional staff.
- Lead functional teams within RCTO.
- Conduct data review.
- Accountable for completeness of Trial Master File.
- Support audit and/or inspection activities
- Primary point of contact for CRO activities.
- May lead process improvement initiatives and departmental projects.
- Performs all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.
Qualifications:
- BA/BS or equivalent or any relevant and qualifying training with a minimum of 6 years of relevant clinical trial management experience.
- Ability and willingness to travel
- Proficiency in CFR and GCP/ICH requirements, as well as European Clinical Trial Directive
- Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.
- Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.
- Strong communication and inter-personal skills.
- Highly responsive and proactive, a team player
- Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
Preferred Qualifications:
- Global Phase I-III trial Management experience
- CRO management.
- Oncology clinical research experience.
- Experience managing large teams (direct or dotted line reporting)
-
Director, Regional Clinical Trial Operations
vor 2 Monaten
Zug, Schweiz Seagen VollzeitPosition 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 Trials Assistant
vor 2 Wochen
Zug, Schweiz Novasyte VollzeitThe IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas. You will be involved in data...
-
Sr. Clinical Project Manager/associate Director
vor 2 Wochen
Zug, Schweiz Kiniksa Pharmaceuticals VollzeitThe 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...
-
Associate Manager, Clinical Business Operations
vor 1 Woche
Zug, Zug, Schweiz Seagen VollzeitPosition Summary:The Associate Manager, Clinical Business Operations is responsible to manage assigned, dedicated Seagen staff as applicable and guide clinical trial operations. Position will serve as key contributor to clinical systems, process development, and support or drive quality initiatives. Position guides day-to-day operational activities.Principal...
-
Clinical Trial Lead.
vor 4 Wochen
Zug, Schweiz PSI VollzeitJob Description The official title for this role will be Regional Project Lead. The Regional Project Lead manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional...
-
Manager, Clinical Supply Chain
vor 3 Wochen
Zug, Schweiz Kiniksa Pharmaceuticals VollzeitThis is an office-based role and will based in one of our offices located in Lexington, London or Zug. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. **Responsibilities **_(including, but not limited to)_**: - Ensure continuous supply of clinical trial material for assigned studies globally - Ensure on-time...
-
Clinical Trial Lead
vor 1 Woche
Zug, Zug, Schweiz PSI VollzeitJob Description Official Position: Regional Project Lead The Regional Project Lead is responsible for managing and coordinating project teams across different countries to ensure consistency in Clinical Operations processes. They play a vital role in ensuring that study milestones are achieved at both country and regional levels. Ensures project...
-
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...
-
Position: Clinical Quality Associate
vor 3 Wochen
Zug, Schweiz Meditrial Europe Ltd. VollzeitMeditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals. Since 2008, Meditrial delivers...
-
Manager, Clinical Supply Chain Mgmt
Vor 4 Tagen
Zug, Schweiz Kiniksa Pharmaceuticals VollzeitThis role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. **Responsibilities **_(including, but not limited to)_**: - Ensure continuous supply of clinical trial material for assigned studies globally - Ensure on-time startup of new studies by having supplies available as...
-
Position: Clinical Quality Associate
vor 1 Woche
Zug, Schweiz Meditrial Europe Ltd. Vollzeit**Company Overview**: Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market...
-
Manager, Clinical Supply Chain Mgmt
vor 1 Woche
Zug, Zug, Schweiz Kiniksa Pharmaceuticals VollzeitThis role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities _(including, but not limited to)_**:Ensure continuous supply of clinical trial material for assigned studies globally Ensure ontime startup of new studies by having supplies available as required Manage...
-
Position: Clinical Quality Associate
vor 1 Woche
Zug, Zug, Schweiz Meditrial Europe Ltd. VollzeitMeditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.Since 2008, Meditrial delivers unparalleled...
-
Local Clinical Operations Manager
vor 2 Monaten
Zug, Schweiz Johnson & Johnson VollzeitLocal 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...
-
Local Clinical Operations Manager
vor 3 Wochen
Zug, Schweiz Johnson & Johnson VollzeitLocal 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...
-
Local Clinical Operations Manager
vor 2 Wochen
Zug, Schweiz Johnson & Johnson VollzeitLocal 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,...
-
Local Clinical Operations Manager
vor 1 Woche
Zug, Zug, Schweiz Johnson & Johnson VollzeitLocal 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,...
-
Medical Director- Oncology Clinical Development
vor 1 Woche
Zug, Zug, Schweiz GSK VollzeitSite Name: USA - Massachusetts - Waltham, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Mar Are you an Oncology clinical research physician with an interest to expand your reach for improving patients' lives who have cancer with a company emerging with innovative medicines? If so, this Medical Director...
-
Local Clinical Operations Manager
vor 1 Woche
Zug, Zug, Schweiz Johnson & Johnson VollzeitLocal Clinical Operations Manager - Schweiz(für Global Clinical Operations Janssen D-A-CH)Über Johnson & Johnson - JanssenSeit 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, ist...
-
Medical Director- Oncology Clinical Development
vor 3 Wochen
Zug, Schweiz GSK Vollzeit**Site Name**: USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham **Posted Date**: Mar 12 2024 Are you a physician in the field of oncology seeking to be ambitious for patients with a premier pharmaceutical company committed to oncology research and development?...