Manager, Clinical Trials

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us

Summary: The Clinical Trial Manager Europe position has three primary responsibilities: Execution of the clinical trial site management functions of a clinical trial, management of staff (direct or indirect) within the clinical trial management team and working with of the cross functional teams representing the clinical operations function.

**Responsibilities**:

- Act as Protocol Lead on one or more clinical trials and serve as the main point of contact for clinical site management and clinical trial site monitoring functions
- Participate as a member of the assigned cross functional study team
- Assist with the review of clinical trial protocols, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management, and other relevant groups
- Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan. Develop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities
- Participate in the identification, evaluation, and selection of clinical trial investigators/sites
- Manage clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals
- Provide support to project CRAs and assist in the initiating, monitoring, and coordinating day-to-day operations of clinical trial sites. May conduct monitoring visits and site visits as needed
- Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories, FSP vendors and Clinical Research Organizations (CRO)
- Primary contact for Clinical Trial Site Monitoring Team to ensure performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work
- Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team
- Ensure completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies
- May assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as regulatory authority inspections
- Establish and maintain good personal relationships with investigators and key opinion leaders in various therapeutic areas
- Support the European Headquarters team across various functions, representing the clinical operation function
- Attend regional and international conferences and congresses to represent the company
- Problem-solve clinical team personnel issues as well as performance issues of CROs/vendors
- Ensure staff training is adequate and documentation of training is up to date
- Should assume responsibility for development and maintenance of some department SOPs or processes
- Participate in the screening, evaluation and hiring process for assigned open clinical operations positions
- Support European Headquarters across various departments and functions

**Qualifications**:

- 5-8 years of relevant Pharmaceutical/Biotech/CRO Industry experience preferred
- Experience in Phase I-III trials required, experience in CRO management is a plus
- Oncology clinical research experience required
- Ability and willingness to travel is required (domestic and international)
- Thorough knowledge of CFR and GCP/ICH requirements. Knowledge of European Clinical Trial Directive required knowledge of regulations on a country level in different EU countries
- Excellent communication and organizational skills
- Experience in working within complex matrix organisatons and across different teams
- Exceptional ability to plan, organize and manage clinical trials
- Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)

Education
- BA/BS in Life Sciences OR equivalent preferred
- Advanced degree in life sciences is a