Clinical Trial Manager - FSP / Sponsor Dedicated

Primary Responsibilities:

• Acts as Global Protocol Lead. Serves as main point of contact for clinical site management.
• May act as mentor for less senior RCTO staff on the study.
• Supports Molecule Lead. Collaborates with internal team members, Contract Research Organizations (CRO), vendors and sites.
• Is the RCTO representative on the Clinical Study Team.
• Assists with design and review of protocols/informed consent forms (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 (TMF).
• Works closely with quality function to ensure inspection readiness. Supports 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 Code of Federal Regulations (CFR), International Council for Harmonization/Good Clinical Practice (ICH/GCP) 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.
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
• Adheres to EP and Client SOPs and processes.