Oracle Life Science is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Oracle Life Science, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Oracle Life science is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Oracle Life Science immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

MISSION

• Assist in Trial Master File (TMF) creation,
• Create and deliver to Investigator Site File (ISF)
• Contribute to project specific documents design;
• Responsible for the quality, compliance and management of study documents, Essential Documents (ED), Investigator Site Files (ISF) and Trial Master File (TMF) throughout the entire clinical trial process (start-up, maintenance and close out).
• Work collaboratively with both internal and external teams to facilitate effective communication
• Guarantee documentation standard are followed on projects
• Identify and mitigate potential risks related to document management
• Active participation in file audits;

QUALIFICATION

• Bachelor's degree or equivalent, preferably in life science or related discipline;
• Fluent level of English (Oral and Written - Toeic > 900);
• Strong Administrative skills;
• 2 years of experience in similar activities in the field of healthcare (clinical research or real world evidence department);
• Excellent organization skills and attention to detail;
• Good knowledge of Word / Excel / Power Point;
• Able to multitask and deal with priorities;
• Good customer service and interpersonal skills, with an ability to engage to different people;
• A real team player, flexible, co-operative and dedicated to helping the team to deliver a great service;

We expressly encourage disabled candidates to apply for this position. Please therefore feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX

Career Level - IC2

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Disclaimer:

Oracle is an Equal Employment Opportunity Employer*. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

* Which includes being a United States Affirmative Action Employer

Thanks to our Business growth Oracle Life Science is looking for a new talented Project Assistant/CTA focusing on assisting our Project teams with the administrative tasks related to different projects.

Typical aspects of the role will include tasks such as set-up, organizing, processing and archiving of clinical trial documents and communication throughout project life cycle.