What are the responsibilities and job description for the Trial Operations Excellence Manager position at argenx US Inc?
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
The Trial Excellence Operations Manager is responsible for the following:
- Responsible for resourcing, development, training, and management of the (global) Clinical Trial Associates (CTAs).
- Drive and/or collaborate on procedure/process improvements projects to optimize efficiency and consistency within the CTA group as well as the wider Trial Operations team.
ROLES AND RESPONSIBILITIES
- Provide leadership, strategic oversight, and guidance to the CTAs in relation to their workload and clinical trial activities.
- Lead and/or support successful internal trainings and mentorship programs.
- Follow up on resourcing needs and lead the CTA hiring and onboarding processes.
- Support the hiring and onboarding processes within the global Trial Operations team.
- Conduct performance evaluations and provide feedback to team members.
- Foster a culture of continuous improvement, innovation, and knowledge sharing within the team and across the organization. Develop, review, and update Trial Operations procedural documents and processes whenever needed.
- Ensure audit/inspection readiness of CTA specific tasks and support audits/inspections if needed. Follow-through with audit/inspection findings to resolution if related to CTA staff.
- Support additional Clinical Development and Global Company initiatives as applicable.
SKILLS AND COMPETENCIES
Strong oral and written communication, facilitation, and interpersonal skills
Good cross-cultural sensitivity
Adaptable and open-minded. Capable of effectively managing and collaborating with individuals from diverse backgrounds, perspectives, and experiences.
Excellent organization and time management skills
Ability to work both independently and as part of a multidisciplinary team
Analytical mindset with a data-driven approach to problem-solving and decision-making
Ability to identify opportunities and drive improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Bachelor’s degree or University degree – medical, para-medical, or equivalent by experience
- Minimum of 3 years of experience in a similar position within Clinical Operations at a biotech, pharma, or CRO
- Minimum of 1 year of experience in a line management/leadership role or proven success as mentor or coach
- Understands clinical trial processes with a thorough Knowledge of International Conference on Harmonisation- Good Clinical Practice (ICH-GCP)
- Knowledge of Drug Information Association Trial Master File (DIA TMF) reference model
- Proficient in software applications such as Outlook, Word, Excel, PowerPoint and Teams.
- Experience with clinical trial management tools and systems such as; Clinical Trial Management System, (e)TMF (Veeva Vault Clinical Operation), Electronic Case Report Form, and Interactive Response Technology system
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At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.
