Clinical Trial Manager

When it comes to life-threatening diseases, we are one family.

We are Kiadis, a biopharmaceutical company that focusses on the treatments of blood cancers aiming to make bone marrow transplantations, safer and more efficient.

As we are a growing company, we are looking to further strengthen our Clinical & Medical organization with a Clinical Trial Manager based in Amsterdam, the Netherlands.

The Role

As a Clinical Trial Manager, you will be responsible for the management and execution of assigned clinical trials. You will ensure that the trials are initiated and conducted in compliance with ICH-GCP and that timelines for completion are controlled. Among your day to day you will:

  • Ensure the qualifications of the external study team members.
  • Initiate contract-, budget- and insurance processes for clinical sites.
  • Oversee and perform site selection activities.
  • Ensure site readiness before sites open for recruitment.
  • Responsible for submissions to EC/IRB.
  • Ensuring in-depth training of sites and CRA’s in study conduct.
  • Prepare the master ICF & site-specific ICFs and ensure the development of master- & site-specific ICFs.
  • Responsible for close sponsor oversight during the trial period.
  • Participates in CRO selection (if applicable).
  • Provide information to support other trial team-members, support more junior colleagues where needed and act as back-up for CTM colleagues.
  • Lead the cross-functional project team responsible for the execution of the assigned clinical trial.
  • Check qualifications of suggested CRA’s.
  • Review CRA visit reports (level dependent on the decision of outsourcing).
  • Participate in study data review and cleaning process.
  • Close cooperation with CRO counterpart (if applicable) and monitoring of CRO activities.
  • Create and approve documents/manuals for study conduct.
  • Perform financial reconciliation of site and CRO invoices.          

The Ideal Candidate

We are looking for someone with a Clinical Trial Phase III background in biotech, and that ideally has knowledge of ATMP and/or Therapeutics. It would be great if you have the following requirements:

  • Minimum of 5 years’ experience in Clinical Research at a level of CTM.
  • Knowledge of ATMP is a big plus.
  • Affinity with or knowledge of hematology, oncology or stem cell transplantations.
  • Knowledge of ICH-GCP requirements.
  • Excellent communication skills, team player mentality and adaptable to change.
  • Fluency in English, other languages are a plus.

What we offer

A challenging position in an innovative, fast-growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.

You will be rewarded with a competitive remuneration package, the opportunity for personal development and to contribute to making a huge difference for patients.

If you're interested in the position please apply through the application button.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Talent Acquisition Department. We kindly request that recruiters do not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Talent Acquisition Department and the recruiting agency will not create any implied obligation.  

About Kiadis Pharma

Kiadis Pharma is a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients. Kiadis Pharma believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), thereby meeting a significant unmet medical need with its products.

More about Kiadis Pharma

Contact information

Kiadis Pharma
Paasheuvelweg 25A
1105 BP Amsterdam
The Netherlands

+31 (0)20 240 52 50
+31 (0)20 240 52 51