Experienced Clinical Project Manager

At BioInvent, we are experts on antibodies and cancer biology and strive for developing first-in-class immuno-modulatory antibodies to treat cancer; treatments that have the potential to considerably improve cancer therapy and the life quality of cancer patients. In our biotech company we are approximately 60 employees and we are covering all parts for drug development, including preclinical research, manufacturing and clinical trials.
Together we all create the exciting future of BioInvent and we welcome you to be part of it - as one of our Clinical Project Managers.

Key Responsibilities
As a Clinical Project Manager you will be part of our positive and engaging clinical development team. You will be leading the team through all aspects of study planning from BID defense meeting to study report. You will communicate and interact with contract research organizations (CROs) and other vendors to ensure smooth study set up and study conduct. You have the oversight of study budget, study timelines, CRO/vendors and site performance and maintaining awareness and solutions of issues raised. You will also support all other involved functions for example the medical expert, regulatory expert and the medical writer.
When needed, you participate in site evaluation visits, site initiation visits and other meetings. Documentation, information and communication both internally and externally is a great part of your responsibility and you also have to reassure that assignments and tasks are performed in line with ICH-GCP and relevant regulation for the conduct of clinical trials.
Requirements
You have experience as a Clinical Project Manager and/or Clinical Trial Manager, preferably experience of phase I/II studies in oncology and /or hematology. Knowledge about ICH-GCP and other relevant regulation to conduct clinical trials is a requirement. Knowledge of IND submission to FDA and other competent authorities and experience of contract and budget negotiations with CROs, vendors, consultants and sites is preferable. You have good computer skills and are knowledgeable in the use of Microsoft Project or similar platform for internal trail setup and oversight. You are proficient in written and spoken English.
The position is office based in Lund.
Skills and Capabilities
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent business judgment, problem solving and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
To summarize, BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!


Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and 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 2020-08-10.


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben