\\n Role & Function

The TMF Operations Specialist is responsible for supporting a high quality TMF by providing quality and operational support to the clinical study teams with the set-up, maintenance, close-out and archiving of the eTMFs.

Key Responsibilities

Support Clinical Study Teams with TMF management in Veeva eTMF

Act as a point of contact for TMF-related queries and provide eTMF status and metrics

Manage eTMF user accesses and provide trainings

Facilitate adherence to the documentation quality requirements and overall TMF good practices

Perform QC of clinical study documents and final TMF in Veeva eTMF and ensure follow up on issues raised

Support study teams in TMF-related interactions with external service providers

Ensure TMF transfer from CROs and other external parties

Assist in TMF related matters during audits, inspections and due dilligence

Contribute to the development and improvement of TMF processes

Qualifications

A university degree or equivalent experience in documentation management

Previous experience in a TMF specialist position from pharmaceutical company or CRO using Veeva eTMF or other Electronic Document Management Systems

Good working knowledge to the TMF Reference Model

Good knowledge of ICH/GCP and other regulatory requirements to clinical study documentation

Understanding of the processes associated with the conduct of clinical studies

Personal attributes

Flexible and communicative attitude

Ability to multi-task and to focus on details

Ability to be a part of a team and to work independently with a proactive approach

In addition, you must demonstrate behaviors in line with Sobi\\\'s core values: Care, Ambition, Urgency, Ownership and Partnership.

Location

The position will be based in Basel, Switzerland.

Reporting to

Head of TMF Operations

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\\xe2\\x80\\x99re ready to take on the world\\xe2\\x80\\x99s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others\\xe2\\x80\\x99 lives because that\\xe2\\x80\\x99s exactly what we do here. If you\\xe2\\x80\\x99re 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\\xe2\\x80\\x99t 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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