Experienced Clinical Project Manager

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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 Clinical Project Manager your main responsibilities 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 relationship 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 affairs, clinical pharmacology).
  • 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,
  • Excellent verbal and written communication skills in English.

We think you have 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. 

You need to have experience in managing multiple project functions both internally and externally, prioritizing workloads and activities to ensure that projects meet critical time points and are within budget. This also includes:

  • 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,
  • Excellent verbal and written communication skills in English.

To manage this role, you need to have a BSc level in relevant life science discipline. Masters/ PhD/ PharmD in related area of discipline (sciences, clinical, business, project management) would be preferable.

We are looking for a driven, structured, self-motivated, independent and responsible person, who understands complex projects and interdependencies and 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, we nurture a culture of teamwork, positive team spirit and promote the development of each member in the team. 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.   

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

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, you are welcome to apply for the position! Please make sure to send in your application as soon as possible, at the latest 17th of October 2021.   

BioInvent has a collective agreement and contact persons for the Unions are Matilda Rehn, Akademikerföreningen and Jenny Nilsson, Unionenklubben  

Additional information

  • Remote status

    Flexible remote

Or, know someone who would be a perfect fit? Let them know!

Lund

Ideongatan 1
223 62 Lund Directions 046-2868550 View page

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