Senior Clinical Trial Manager
Senior Clinical Trial Manager
Seagen
Rueil-Malmaison, France
Summary:
The Senior 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. May act as people manager to more junior staff.
Principal Responsibilities:
- Acts as Global Protocol Lead (or Molecule Lead for smaller programs). Serve as main point of contact for clinical site management.
- May manage more junior staff. Dotted line oversight of Functional Service Provider resources.
- May act as mentor for less senior RCTO staff on the study.
- Supports Molecule Lead. Collaborates with internal team members, Contract Research Organizations, vendors and sites.
- Is the RCTO representative on the Clinical Study Team.
- Assists with design and review of protocols/ICFs and other study documents.
- Leads in identification, evaluation, and selection of clinical trial sites.
- Coordinates and manages vendor processes.
- Accountable for tracking of ancillary and investigational supplies, specimens and/or imaging.
- Facilitates communication between sites and Seagen cross-functional staff.
- Leads functional teams within Regional Clinical Trial Operations
- Conducts data review.
- Accountable for completeness of Trial Master File.
- Work closely with quality function to ensure inspection readiness. Support audit and/or inspection activities.
- Primary point of contact for CRO activities.
- Ensures training compliance of all staff.
- Contributes to process improvement initiatives and departmental projects.
- Performs all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.
- Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations.
- Ability to work successfully in an entrepreneurial and fast-moving environment.
Qualifications:
- BA/BS or equivalent or any relevant and qualifying training with a minimum of 8 years of relevant clinical trial management experience.
- Ability and willingness to travel
- Global Phase I-III trial Management experience.
- CRO management experience.
- Thorough knowledge of CFR and GCP/ICH requirements as well as European Clinical Trial Directive.
- Experience managing large teams (direct or dotted line reporting)
- Excellent leadership, communication, and organizational skills.
- 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 (eg, CTMS, EDC and eTMF)
- Oncology clinical research experience (preferred).
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