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.
We are looking for a Trial Oversight and Patient Data Integration – Data Acquisition Lead. This role will lead the Trial Oversight Platform (elluminate) initiatives within the Data Integration & Standards Team to promote the adoption of data visualization and collaboration capabilities across argenx Clinical Development and with our external Partner Ecosystem.
This role will report to the Head of Data Integration & Standards Team, Data Acquisition, and provide support to the Head of Data Integration & Standards Team, establishing a strong foundation for efficiency, scalability and de-risking staff dependency.
Additional responsibilities include leading the integration of Clinical Trial data with patient Real World data, and providing support to internal teams and strategic outsourcing partners for clinical data submissions to regulatory authorities.
The successful candidate will contribute to shaping the Trial Oversight Platform roadmap by assessing the latest advancements in technology, and collaborate closely with other Data Acquisition Leads, the Head of Real World Data (Health Economics Outcomes Research – HEOR), Quantitative Sciences (QS), Clinical Trial Operations and Business Information Systems (BIS).
Roles and Responsibilities:
* Support the Head of Data Integration & Standards Team in managing strategic partner oversight (eClinical Solutions – eCS) for the Trial Oversight & Collaboration platform, improving Oversight and Tracking, communication of findings within Data Acquisition and beyond.
* Take a leadership role in the integration of Clinical Trial data with patient Real World data supporting the Head of Data Integration & Standards Team. Provide ad hoc support to the Head of Real World data (HEOR) within argenx.
* Take a leadership role in the development of WIs and Job Aids for data acquisition. Lead or participate in Process Improvement / Excellence projects.
* Ad hoc support for the Head of Data Integration & Standards, including, but not limited to participation in regulatory agency inspections and internal audits, back up during holidays.
* Line management responsibilities. Ensure resourcing capacity is in line with project plan and deliverables. Enable the growth and development of direct reports.
Skills and Competencies:
* Knowledge of ICH-GCP, CDISC and other applicable regulations.
* Advanced knowledge of Data Visualization & Collaboration platform(s) within Clinical Development.
* A strong team player capable of working independently while managing a diverse team of multidisciplinary colleagues, including both direct and indirect reports.
* Advanced knowledge of HealthCare systems/data.
* Strong communication and interpersonal skills.
* Fluent in English (written and spoken).
Education, Experience and Qualifications:
* Bachelor’s degree or Master’s degree – medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or Information Technology or equivalent by experience.
* Experience managing partners.
* Experience at vendor side (CRO or/and Software) for Clinical Development is recommended.
* Experience in Clinical Data Management is a plus.
* Experience at HealthCare side for Hospital systems/patient data is recommended.
* Demonstrated experience with HealthCare standards.
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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.
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