Experienced Clinical Project Manager

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 aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as one of our Clinical Project Managers.
Key Responsibilities
The responsibilities of the position include, but are not limited to:
Managing and leading all aspects of clinical study projects from study planning to close-out and study report.
Selection and oversight of performance of Clinical Research Organizations (CROs) and other vendors.
Oversight and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget.
Study site selection and performance and participation in site visits (qualification, initiation, monitoring).
Participate in establishing, monitoring, and maintaining procedures (SOPs) to ensure program meets all GCP/ICH Guidelines and is Inspection Ready.
Support maintaining BioInvent’s relatiship with KOLs and PI’s.
Organizing and participating internal and external meetings as required.
Co-development and review of study documents e.g., study protocol, informed consent form, monitoring guidelines, study manuals, Case Report Forms, regulatory authority submissions.
Routinely review of study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies (e.g., reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals).

Working closely with and cross functional teams at BioInvent (e.g., with manufacturing, pre-clinical, regulatory).
Requirements
At least 7 years experience as a Clinical Project Manager and/or Clinical Trial Manager, preferably experience of early phase studies in oncology and /or hematology.
Experience in managing multiple project functions both internally and externally, prioritizing workloads and activities to ensure projects meet critical time points and are within budget.
Vendor Oversight experience.
Deep knowledge about ICH-GCP and other relevant regulation to conduct clinical trials.
Knowledge of IND/CTA submission to FDA and other competent authorities
Experience of contract and budget negotiations with CROs, vendors, consultants and sites.
Proficient in MS Word, Excel, Power Point, Outlook, MS Project.
Proficient in written and spoken English.



Qualifications:
Educated to BSc level in relevant life science discipline.
Desirable: Masters/ PhD/ PharmD in related area of discipline (sciences, clinical, business, project management)



Personal Profile:
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 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!
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 17 April 2021.


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