Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

Role & Function

The Senior CTA has the overall responsibility to provide administrative and logistical support for clinical studies in compliance with Sobi standard operating procedures, ICH/GCP guidelines and applicable regulatory requirements.

This is a remote position with occasional travel/office days. Candidate must live in the Durham NC area and have the ability to come into the Durham office when necessary #Li-Hybrid

Key Responsibilities

• Managing several aspects for multiple clinical studies, in conjunction with the clinical study managers (CSMs), in accordance with agreed timelines and budget and ensuring their execution and delivery.

• Set-up and maintain clinical tracking tools and study contact lists

• Organize and participate in meetings e.g., clinical study team (CST) meetings. Distribute agendas & generate meeting minutes.
• Assist with handling of contracts with e.g., external service providers (ESPs), hospitals and laboratories.
• Participate in the review of clinical data in the clinical database, data listings, and reports
• Arrange confidential disclosure and consultancy agreements.
• Manage components of the study budget including preparation of purchase orders, invoice processing and tracking, and reporting of monthly accruals.
• Process documents in relevant electronic document systems e.g., DocuSign, internal/external SharePoint sites and Microsoft Teams.
• Oversee the trial master file (TMF) by conducting quality reviews and performing reconciliation in collaboration with the CRO as applicable.
• Coordinate quality control of study documentation, including preparation for internal/external audits, and regulatory inspections.
• Prepare, review and/or quality control study documents, such as manuals, templates, logs and forms
• Collect, distribute and track study documents as applicable e.g., Investigators Brochures, clinical study protocols, patient information documents, newsletters and clinical study reports.
• Update clinical studies on clinical trial registries and clinical trial results databases.

Qualifications

• Required:• At least 3 years’ experience with clinical study processes and documentation• IT literacy (particularly Word, Excel, PowerPoint and database management systems)

• Desired:
• • A university degree or equivalent in health sciences, nursing or pharmacy or related field.• Previous experience of working within clinical drug development (head quarter, affiliate or contract research organization)

• Skills/Knowledge/Languages: Required:• Good written and oral communication skills in English• Strong working knowledge of Microsoft Office• Knowledge of drug development, clinical study processes and ICH/GCP

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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