Manager, Study Start Up

Seagen

View: 135

Update day: 20-03-2024

Location: Zug Zug ZG

Category: R & D IT - Software

Industry: Biotechnology Research

Position: Mid-Senior level

Job type: Full-time

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Job content

Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

This in-house position is responsible for site start-up activities and includes coordination, management, and oversight of site start-up for two or more clinical studies. This position includes direct management of staff within the study start-up team.

Principal Responsibilities
  • Accountable for site start-up for 2 or more clinical studies
  • Serves as primary point of contact and escalation for site start-up on assigned clinical studies
  • Holds start-up Kick Off Meeting with SSU Study Manager EU, PL, CCM, Legal, and other key stakeholders
  • Holds weekly start-up meetings with SSU Study Manager EU, PL, CCM, Legal, and other key stakeholders as necessary
  • Forecasts and tracks progress of site start-up, ensuring all sites on assigned clinical trials are greenlit on time per SSU timelines
  • Escalates site issues to appropriate Clinical Study Team members
  • Attends Clinical Study Team Meetings through start-up
  • Prepares and updates start-up packets for clinical studies
  • Assigns sites to SSU Specialists, and manages SSU Specialist and SSU Assistant workload for assigned studies
  • Ensures SSU Specialists collect, review, and track essential documents, and review ICFs in accordance with Seagen processes and timelines
  • Responsible for reviewing greenlight packets and greenlighting sites
  • Ensures SSU team members are properly trained on site start up activities and kept current on timelines, contract and budget status, and study updates for assigned clinical studies
  • May be responsible for sending start-up packets, reviewing ICFs, collecting essential documents, and helping sites with IRB submissions for one or more clinical sites
  • Includes the following management responsibilities:
    • Problem-solving clinical team personnel issues
    • Managing internal (dotted line or functional) SSU Study Managers, SSU Specialists and SSU Assistants. Providing timely feedback to assigned staff on personal and project-specific performance, and providing guidance on performance improvements as necessary
    • Performing performance evaluations and providing assigned staff with constructive feedback to enhance performance. Serving as mentor to help assigned staff develop their career paths.
    • Ensuring staff training is adequate and documentation of training is up to date
    • Review and revise SSU staff project assignments as needed to balance workload
  • Infrastructure Development/Maintenance:
    • Improve existing and / or implement new systems and processes. Become subject matter expert and provide cross functional support for complex processes
    • Facilitate various oversight activities, including internal process or clinical quality measures to ensure consistency across SSU Team
    • Evaluate, refine and train on departmental SOPs, guidelines and templates and forms
    • Initiate and manage the hiring process for assigned open job positions
Required Qualifications
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years of relevant clinical trial experience
  • Minimum of 2 years clinical trial management or equivalent start-up unit management experience
  • Thorough knowledge of clinical start-up process and requirements required
  • Thorough knowledge of CFR and GCP/ICH requirements is required
  • Requires effective organizational and time management skills
  • Able to multi-task under limited direction and on own initiative
  • Strong communication and inter-personal skills
  • Ability to coordinate work cross-functionally with diverse teams
  • Highly responsive and proactive, a team player
Preferred Qualifications
  • 5 – 8 years of Pharmaceutical/Biotech Industry experience. An advanced degree is preferred
  • Previous start-up unit experience
  • Experience managing large teams (direct or dotted line reporting)
  • Oncology clinical research experience
  • Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint
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.
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Deadline: 04-05-2024

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