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Manager, Study Start Up
Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Summary:
The Study Start-Up Unit at Seagen is a group dedicated to supporting Seagen’s portfolio of clinical studies in all phases to expedite site activation globally. The Study Start Up Unit is accountable for all site start-up activities flowing after site selection to site initiation readiness including contract and budget negotiation, IRB/EC applications and approvals, and essential document collation.
The Manager, Study Start-Up (SSU) may have global or regional responsibilities. The role will lead an SSU team supporting Seagen sponsored clinical trials by providing management and oversight of the Site Start-Up process, conducting business operations as detailed below, and ensuring that study deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position will work closely with stakeholders such as clinical study teams, clinical contracts teams, clinical project managers and vendors.
Principal Responsibilities:
Accountable for performance of the Study Start Up team and relevant vendors in their assigned region- Serves as primary point of contact and escalation for site start-up in assigned region
- Attends start-up Kick Off Meeting with SSU Manager, Protocol Lead (PL), Clinical Contract Manager (CCM), Legal, and other key stakeholders as time allows to ensure regional SSU processes are clear and being maintained
- Attends weekly start-up meetings with SSU Manager, PL, CCM, Legal, and other key stakeholders as time allows to ensure regional SSU processes are clear and being maintained and RCTO goals are being met
- Forecasts and tracks progress of site start up, ensuring all studies are on target to greenlight sites on time per SSU timelines
- Escalates study wide issues to AD, SSU and appropriate Clinical Study Team members in their region
- Assigns studies to Study Start Up Specialists in assigned region
- 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 as necessary
- 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
- Includes the following management responsibilities:
- Problem-solving clinical team personnel issues
- Managing internal (dotted line or functional) SSU Associate Managers and Specialists
- 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
Qualifications:
Minimum of six (6) years of relevant clinical trial experience- Minimum of three (3) years clinical trial management or equivalent Start-Up management experience.
- Experience managing teams (direct or dotted line reporting)
- Thorough knowledge of clinical start-up process and requirements
- Thorough knowledge of CFR and GCP/ICH requirements, as well as European Clinical Trial Regulation
- 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.
- Oncology clinical research experience, preferred.
- Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.
- Proficiency in English written and verbal communication.
Education:
BA/BS or equivalent or any relevant and qualifying training- An advanced degree is 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 visit www.Seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.
