Seattle Genetics Clinical Trial Manager in Bothell, Washington


Seattle Genetics


Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Job ID 1844
Location: Bothell, Washington
Job Code: 1611RT-03 #LI-BC1
# of Openings: 1


Description:

Summary:

The Clinical Trial Manager position has three primary responsibilities: Execution of the clinical trial site monitoring functions of a clinical trial (e.g. those functions having to do with the clinical trial site), management of staff (direct or indirect) within the clinical trial management team, and development of standards and practices within the clinical trial management group.

Responsibilities:

Project Responsibilities

  • Act as Protocol Lead on one or more clinical trialsand 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
  • 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
  • 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 field CRAs and may assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. May conduct monitoring visits including pre study, initiation, interim monitoring and close visits as needed
  • Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO)
  • Primary contact for 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 ofClinical 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

Management
  • Work with department directors to set goals for the clinical trial management team
  • Problem-solve clinical team personnel issues
  • Manage internal (dotted line or functional) and external Clinical Research Associates (CRAs), and other external clinical trial service vendors as necessary. Provide timely feedback to assigned staff on personal and project-specific performance, and provide guidance on performance improvements as necessary
  • Perform performance evaluations and provide assigned staff with constructive feedback to enhance their performance.Serve as mentor to help assigned staff develop their career paths.
  • Ensure staff training is adequate and documentation of training is up to date

Infrastructure Development/Maintenance
  • Should assume responsibility for development and maintenance of some department SOPs or processes
  • May become subject matter expert for complex processes within the clinical trial management team
  • Ensure assigned team (dotted line or functional) adheres to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides)
  • Participate in maintenance and update of job descriptions
  • Participate in the screening, evaluation and hiring process for assigned open clinical operations positions


Qualifications:

REQUIREMENTS:
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 8 years of relevant Pharmaceutical/Biotech Industry experience. An advanced degree is a plus
  • Experience in Phase I-III trials and CRO management is preferred
  • Experience managing large teams (direct or dotted line reporting) is preferred
  • Oncology and hematology clinical research experience preferred
  • Ability and willingness to travel is required (domestic and internationally)
  • Thorough knowledge of CFR and GCP/ICH requirements.Knowledge of European Clinical Trial Directive is preferred
  • Excellent communication and organization skills
  • 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)

PI96074720