Clinical Trial Manager
Vor 6 Tagen
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)
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