Associate Director, Field CRA

Clinical Development Operations US Field Based


Description

Summary

The Associate Director, Field CRA, Regional Clinical Trial Operations is a critical role responsible for Execution of site management and monitoring functions of clinical trials, Management and mentoring of staff within the Clinical Trial Management group (e.g. Regional Field CRA Managers, a team of Field CRAs), and Oversight of Field CRA team processes including development and maintenance of standards and practices within the RCTO group.  This position will help build and support the strategic vison of the Field Monitoring team.

  
Principal Responsibilities

Project and Management Responsibilities

  • Represents Regional Clinical Trial Operations in senior level, cross-functional teams and committees.
  • Along with the Director, Regional Clinical Trial Operations, establishes a strategic vision and long-range plan for the RCTO team and determines the best utilization and the optimal organization of the RCTO infrastructure and staff.
  • Helps build strong Regional Clinical Trial Operations teams and makes decisions on selecting and resourcing RCTO staff.
  • Directly manage a large RCTO team that may include Regional Field CRA Managers and Field Clinical Research Associates.
  • Provide Field CRA Managers and staff with appropriate coaching, mentoring and development. May conduct monitoring visits as needed.
  • Manage Field CRA team metrics (ie, monitoring frequency, trip report completion), transitions, and performance for assigned studies. Ensure completeness of CTMS and TMF.
  • Facilitate information flow between in-house study team, field team, vendors, etc.
  • Serve as primary contact for vendors for study resourcing and to ensure performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work.
  • May contribute to RCTO activities on all phases and complexity of trials from First to Human to Global Phase 3. Provide clinical trial monitoring function input for clinical trial start-up and CRA study-specific training activities.
  • May review molecule and study level documents, such as the protocol, Investigator Brochure, Pharmacy Instructions, Case Report Form and Inform Consent Form
  • Participate in the preparation and follow-up of in-house and on-site Seagen sponsored quality audits, as well as, regulatory authority inspections.
  • Serve as Subject Matter Expert in one or more area. May be internal or external-facing and may be cross-functional.

Infrastructure Development and Maintenance

 Develops new or leads the improvement of existing department systems and processes.

  • Leads the implementation of process improvements or of new process across RCTO.
  • Develops or improves SOPs and training guides applicable to a global organization.
  • Facilitate various Field CRA oversight activities, including internal process and clinical quality measures to ensure consistency across departments (e.g. analyze monitoring metrics across the team and report out).
  • Ensures consistency and best practices are followed on all processes, protocols, and clinical systems, such as within the Clinical Trial Management System (CTMS) and electronic Trial Master File.
  • Ensures proper training is implemented to demonstrate CFR, GCP/ICH compliance.

Leadership & Functional Competencies

  • Collaborate with Head of Clinical Monitoring, other Regional Field CRA Managers, and PLs to meet project resourcing needs, resolved potential resourcing conflicts, facilitate mutually beneficial resolutions, and to address study performance issues.
  • Develop strategies for ongoing growth and development of Regional Field CRA management team.
  • Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations.
  • Ability to work successfully in a mid-stage biotechnology culture where a premium is placed on delivering science-based results in an entrepreneurial, fast moving and a sometimes resource constrained environment.

 Qualifications

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 11 years of relevant clinical trial management experience. Advanced degree preferred.
  • Significant clinical operations experience spanning Phase I-III trials, past participation in NDA or BLA process desirable.
  • Oncology trial experience preferred, or experience with trials in similar disease states.
  • Proven ability to effectively manage a large staff of Field CRAs and/or Field CRA Managers.
  • Intense drive and exceptional organizational expertise are necessary to manage the diverse group of functional activities. Ability to proactively handle multiple tasks simultaneously are required.
  • Proficiency in CFR, GCP/ICH and regulatory issues is essential.
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC, and eTMF).
  • Able and willing to travel approximately 30%.

Education

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 11 years of relevant clinical trial management experience. Advanced degree 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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