Senior Manager Regional Clinical Trial Operations
seattlegenetics
 Seattle, WA

Summary:

The Senior Manager, Regional Clinical Trial Operations (RCTO) position has three primary responsibilities: Execution of the clinical trial including site management functions, management and mentoring of staff within the clinical trial management group, and development of standards and practices within the RCTO group.

Principal Responsibilities:

  • Act as Protocol Lead on large complex clinical trials, including Global Phase 3 trials, or several smaller clinical trials. May also oversee a suite of protocols within a program
  • Participate as a member on assigned cross functional study team
  • Will assist with the design and 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. Participate in the Clinical Protocol Committee as appropriate
  • 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, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate
  • Participate in the identification, evaluation and selection of clinical trial investigators/sites
  • Assist in oversight of CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work
  • Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed
  • Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate
  • Ensure completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned programs
  • Participate in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections

Management:

  • Work with director to set goals for Regional Clinical Trial Operations. Manage team to achieve goals
  • Train and mentor new CTMs, CRAs and other clinical staff in CFR, and ICH /GCP
  • Empower and coach clinical staff members to accept responsibility for their work, to work independently and excel at their assigned projects
  • Manage assigned team (direct and indirect), providing timely feedback on personal and project performance. Perform performance evaluations and help develop their career paths
  • Ensure RCTO staff training is adequate and documentation of training is up to date
  • Review and revise clinical staff project assignments as needed to balance workload

Infrastructure Development/Maintenance:

  • Improve existing and / or implement new department systems and processes. Become subject matter expert and provide cross functional support for complex processes
  • Facilitate various oversight activities, including CRO, SMO, vendors, internal process or clinical quality measures to ensure consistency across department
  • Evaluate, refine and train on departmental SOPs, guidelines and templates and forms.
  • May maintain and update of job descriptions for the group
  • Initiate and manage the hiring process for assigned open job positions

Qualifications:

  • 10 years of relevant clinical trial management experience
  • Experience in the pharmaceutical industry is required. An advanced degree preferred
  • Experience managing CRO relationships
  • Experience managing personnel is required
  • Oncology and Hematology Clinical Research experience preferred
  • Ability and willingness to travel is required (domestic and internationally)
  • Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required
  • Excellent leadership, communication and organization skills
  • Exceptional ability to plan, organize and conduct clinical studies with minimum oversight
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)

Education:

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 10 years of relevant clinical trial management experience
  • Advanced degree preferred

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.

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