Seagen

Senior Manager Field CRA

Description

Summary

The Senior Regional CRA Manager has three primary responsibilities:

1. Execution of the site management and monitoring function of clinical trials,
2. Management and mentoring of staff within the Clinical Trial Management group (e.g. Regional Field CRA Managers, a team of Field CRAs),
3. Oversight of Field CRA team processes including development and maintenance of standards and practices within the RCTO group.

Principal Responsibilities:

Project Responsibilities

• Develop and maintain effective relationships with study and management teams to optimize feedback and collaboration
• Act as molecule lead on one or more molecules in support of its respective studies, partnering with Protocol Leads for resourcing, clinical site management and clinical trial site monitoring functions
• Provide clinical trial monitoring function input for clinical trial start up and CRA study specific training activities
• Help resolve complex issues
• Manage Field CRA team metrics (i.e. monitoring frequency, trip report completion), transitions, and performance for assigned studies
• Provide support to field CRAs. May conduct monitoring visits as needed
• Serve as primary contact for CROs or FSPs for study resourcing and to ensure performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work
• Facilitate information flow between in-house study team, field team, Regional Managers, vendors, CROs, etc.
• Ensure completeness of CTMS and TMF
• Support the preparation and follow-up of Seattle Genetics sponsored quality audits and regulatory authority inspections as requested
• Provide support to the broader field CRA team and Regional Managers in day-to-day job functions

People Management

• Supervise and mentor/coach Regional Managers and/or team of Field CRAs
• Guide professional development, complete performance reviews and implement performance improvement plans as necessary
• Meet regularly with direct and dotted-line reports to coach, mentor, train, advise, and evaluate workload, metrics and training compliance
• Assist with complex issues resolution
• Assess quality of deliverables including monitoring reports and other reports through periodic review
• Perform QC or co-monitoring visits as needed
• Provide strong leadership, encourage engagement, innovation and open communication while supporting company goals

Infrastructure Development/Maintenance:

• Contribute to strategies for ongoing growth and development the Regional Field CRA Management team
• Collaborate with Head of Clinical Monitoring, other Regional CRA Managers, and PLs to meet project resourcing needs, resolve potential resourcing conflicts, facilitate mutually beneficial resolutions, and to address study performance issues
• Facilitate various CRA team oversight activities, including, internal process or clinical quality measures to ensure consistency across department (e.g. analyze monitoring metrics across the team and report out)
• Contribute to development, maintenance, and execution of Field CRA team training and onboarding plans
• Lead or participate as a member on assigned process RCTO initiatives
• Manage various RCTO activities as assigned
• Assist with change management
• Develp and implement new or improve existing department processes
• Serve as subject matter expert and provide cross functional support for complex processes
• Evaluate, refine and train to departmental SOPs, guidelines, templates and forms
• May maintain and update job descriptions for the group
• Initiate and manage the hiring process for assigned open job positions
• Work with the director and Regional Field CRA Managers to set goals for the Field CRA Team. Manage teams to achieve goals

Qualifications:

• BA/BS, or equivalent, or relevant experience and training with a minimum of 10 years of clinical trial experience in the pharmaceutical/biotech industry. Advanced degree, RN, or health care professional preferred
• Monitoring experience is required, preferably in trials phase 1-3
• Oncology clinical research experience is preferred
• Proficiency in CFR and GCP/ICH
• Experience working on global clinical trials is preferred
• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC, and eTMF)
• Experience managing people and teams (direct or dotted-line reporting) is required (2 year minimum)
• Excellent leadership, communication and organizational skills
• Exceptional ability to plan, organize, and execute department initiatives and other work.
• Able and willing to travel approximately 30%

Education:

• BA/BS, or equivalent, or relevant experience and training with a minimum of 10 years of clinical trial experience in the pharmaceutical/biotech industry. Advanced degree, RN, or health care professional preferred

As the leading employer in our industry in the Pacific Northwest, 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. 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 Seagen, please visit www.seagen.com.

Seagen 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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/05/2021