TMF Operations and System Specialist

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Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here At Sobi, Our Mission And Culture Get Us Excited To Come To Work Every Day, But Here Are a Few More Reasons To Join Our Team

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
  
  

Job Description

Are you a skilled TMF Operations and System Specialist looking to make a difference in the world of clinical drug development? Join our dynamic team at Sobi, where your expertise will shine and your contributions will be valued.

The TMF Operations and System Specialist is an eTMF system SME, managing the business administration of the eTMF system, specifically by ensuring the eTMF system is aligned to Regulatory guidelines for document management systems, and Sobi internal quality standards for computer compliance as well as business requirements.

Key Responsibilities

Including, but not limited to the following

• Ensures eTMF functionalities are aligned to clinical business processes and requirements on an ongoing basis, by active collaboration with internal stakeholders
• Manages the relationship with external vendor to ensure eTMF system configuration is aligned to internal business needs and proactively work on further development
• Responsible to review regular system releases and additional configuration updates following Sobi change management process in collaboration with IT
• Ensure continuous oversight of eTMF user access process and collaborates with IT to maintain a lean onboarding process for all users into the eTMF system
• Collaborates with IT and business functions to support periodic system audit trail reviews
• Contributes to the development and improvement of TMF processes and best practices
• Ensure operational support to clinical study teams with the eTMF system management during audits and inspections, as applicable
  
  

May assume TMF Operations Specialist responsibilities within a program or project, depending on business needs

Qualifications

• University degree, preferably in Life Sciences but not mandatory
• Previous experience (3-5 years) of working within clinical drug development (pharmaceutical company or contract research organization) and understanding of the processes associated with the conduct of clinical trials
• Previous experience (2-3 years) in eTMF/eDMS system administration
• Management of medical/clinical study documentation and knowledge of ICH/GCP and other regulatory requirements to clinical study documentation
• Excellent written and verbal communication skills in English
• Knowledge of drug development, clinical study processes, and ICH/GCP, Regulatory requirements and industry best practices
• IT literacy with demonstrated experience in electronic document management systems
  
  

We value you as a person and the team so we want you to:

• Be willing to be an active member of the team, share ideas and business knowledge
• Be ccommunicative and flexible in attitude, working with shifting priorities
• Have strong analytical and problem-solving skills
• Have the ability to work independently on projects with a proactive approach
  
  

All Sobi employees need to demonstrate behaviours in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease

Additional Information

Why Join Us?

We are a global company with over 1,700 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.