Manager Study Start Up

Vor 5 Tagen

Zug, Schweiz Seagen Vollzeit

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. It includes direct management of staff within the study start-up team.

The position can be based in our HQ in Zug or, as an alternative, in Italy, Germany or the UK.

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:

- 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 interpersonal 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

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