Seattle Genetics

Clinical Trial Manager (CTM) Europe

Description

Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) uses the company’s industry-leading antibody-drug conjugate (ADC) technology and is approved for the treatment of multiple CD30-expressing lymphomas.

Beyond ADCETRIS®, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing or planned pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer use our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors.

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.

Principal 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 on 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 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.

Requirements:

• 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 organization skills.
• Experience in working within complex matrix organizations 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 plus.

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 07/19/2019