Senior Clinical Trial Manager

Job content

Description

Position at Seagen

Summary

The Senior Manager Clinical Trials 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. 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
• 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 of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies
• Participate in the preparation and follow-up of in-house and on-site Seagen 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 CTM 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 a leading employer in our industry, Seagen 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. To learn more about Seagen, please visitwww.Seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.