#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
The Clinical Trial Associate is responsible for supporting the Clinical Trial Leader and Clinical Program Team in coordinating and managing of assigned clinical trials sponsored by Polpharma Biologics. This role will be operationally responsible for Clinical Trial related documentation (Trial Master Files) and reports to the Director of Clinical Research and Development.
- Function as Clinical Trial Associate (CTA) for assigned Clinical Trials
- Support the Clinical Program Head and clinical team for clinical program related activities
- Take responsibility for operational activities regarding accuracy and completeness of the clinical trial related documentation (e.g. support Trial Master File)
- With the support of the Clinical Trial Lead (CTL), develop and implement measures of oversight and quality control regarding Trial Master File documentation located, from study start-up until archiving.
- Supporting the CTL in planning, facilitating the Integrated Clinical Team (ICT) Meetings to ensure all trial deliverables are met
- Supporting the CTL in vendor selection and development of trial specifications with vendors and appropriate line function input
- Supporting the CTL in Management of vendor start up, development of data specifications, and oversight of vendor activities and interactions during the trial
- Supporting the CTL in managing and coordinating study drug (in cooperation with the clinical trial supplies manager) and non-drug supplies across regions/countries
- Supporting the CTL in managing overall trial conduct to trial close out in coordination with line functions and vendors
- Provide oversight and support to Study Team activities for clinical trials under the supervision of the CTL
- Support the development and implementation of new process improvement initiatives/SOPs related to trial and clinical quality management
- Languages: English (fluent). Polish or German is a plus
- Education: Bachelor’s degree or equivalent qualification in life science/healthcare, Master’s degree preferred
- Thorough knowledge of Good Clinical Practice (GCP, ICH), regulatory processes, and clinical development process
- Experience: Minimum 5 years operational experience in planning / executing / reporting clinical trials
- Experience with Trial Master File Management, preferably experience with DIA Reference Model.
- Ability to work in a global cross-functional teams (including external partners)
- Experience with clinical studies for Biologic/Biosimilar products is a plus.
- Ability to conduct operationally efficient processes, and have skills in managing process
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
