Clinical Trial Assistant

BioInvent International AB (OMXS: BINV) is a clinical stage company focused on the development of novel, first-in-class immuno-modulatory antibodies for the treatment of cancer, addressing the need for novel treatment options that have the potential to significantly improve patient outcomes. Our powerful discovery engine is based on our validated, proprietary F.I.R.S.T.™ technology and our proprietary n-CoDeR® antibody library to simultaneously identify targets and antibodies that bind to these targets, generating many promising new drug candidates to fuel the Company’s proprietary product pipeline as well as for licensing and partnering purposes. More information is available at www.bioinvent.com.
The BioInvent team covers all parts for drug development, including preclinical research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as our Clinical Trial Assistant.


Key Responsibilities
As a Clinical Trial Assistant, you will be part of our clinical development team and provide support to the Clinical Project Manager in assuring a comprehensive clinical study management and operation for the day-to-day work.
The responsibilities of the position include, but are not limited to:
Assisting in vendor selection and management.
Contribute in the development of study documents such as study specific plans, manuals, eCRF/guidelines, ICF, trial protocol.
Assist in study oversight activities (maintenance of tracking systems),
Oversight and coordination of sample shipment to central labs.
Collection and filing of documents in the TMF, conduct of TMF QC.
Support IMP handling and tracking.
Assisting in review of monitoring reports.
Contribute to implementation and maintenance of clinical Quality Management System (cQMS) and adaption to the need of the individual study.
Assisting in activities related to clinical trial applications to regulatory authorities and ethics committees.
Provide support to in change controls, GCP and protocol deviations, CAPAs.
Ensure to attend and receive ongoing training to relevant clinical and quality regulations and guidelines.
Participate where appropriate in clinical /cross-functional meetings.
Assist the VP Clinical Development and Regulatory management in activities related as needed.


Requirements
In-depth knowledge of ICH-GCP and ensure to attend and receive ongoing training to relevant regulations and guidelines.
Excellent verbal and written communication skills in English.
Excellent experience in Microsoft Office suite of applications
Ability to work with multiple projects and tasks simultaneously.
Efficient, solution-oriented mindset, good organization skills, multi-tasking, quick learner, respond to urgent needs of the team.
Self-motivation and independent.
Nurture a culture of teamwork, positive team spirit, promoting the development of each member in the team.
Knowledge and understanding of the importance of creating efficient working environment and contributing to ensure continuous improvements. Able to be at ease with frequent changes, delays, or unexpected events.
Perform all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.
Knowledge and understanding of the overall BioInvent´s key objectives and well versed in the company structure and other departments.

Qualifications:
University degree in natural sciences/engineering or degree in nursing.
Two (2) to Five (5) years of clinical research experience as a clinical trial associate, clinical research associate and/or clinical study coordinator from CRO, Pharma and/or Biotech companies.

Location:
The position is office based in Lund. However, the position may also offer a flexible working arrangement.

Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 30 June 2021.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben