Clinical Trial Manager (focus on sponsor oversight)

Kiadis Pharma is a biopharmaceutical company based in Amsterdam, The Netherlands. We focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a risky procedure that is often the last hope for patients, safer and more efficient. This means we have a passionate team that is dedicated to make a huge difference for patients. If you are up to the challenge and would like to be part of our team, we are currently looking for a Clinical Trial Manager with a focus on sponsor oversight (also called Clinical Monitoring Liaison -CML - below) to further strengthen our Medical & Clinical organization.

PURPOSE OF THE ROLE

  • As CTM this oversight role will be called clinical monitoring liaison (CML)
  • developing long-term relationships with clinical investigators
  • providing an interface between the company, the investigator and the CRO and CRA’s
  • providing oversight of study conduct at the investigative sites in outsourced global trials to create the environment for successful and high quality clinical trials

KEY TASKS & RESPONSIBILITIES  

As clinical company representative to sites, establish and cultivate professional relationships to produce excellent site performance in our trials and repeat opportunities to work with sites on other studies.

  • Perform on site visits with CRO staff to evaluate and ensure quality of site and CRA performance, escalating issues or concerns and documenting in the appropriate surveillance visit report.
  • Support the CRO  CRA and demonstrate partnership to sites and investigative staff.
  • Provide a point of contact for the investigator on general questions and issues related to the trial CRO
  • Propose and implement solutions in collaboration with the project CTM’s and/or escalate issues according to the agreed process
  • Work with project team, CRO and sites in general to develop site specific recruitment strategies based on the recruitment plan for the trial and other best practices that will enhance their success as a trial site.
  • As a company representative attend and actively participate in Investigator meetings, , and other professional meetings
  • Develop the knowledge of site capabilities and past performance, and nominate and identify potential new sites for clinical trials
  • Identify opportunities to improve company and CRO relationships with sites
  • Contribute to the distribution of information to Key Opinion Leaders (KOLs) and/or developing and maintaining relationships with current or future KOLs.
  • Interact with company trial team members to provide support in identifying and assessing site specific issues such as study status, site performance, compliance, etc…
  • Maintain knowledge of therapeutic areas of study
  • The CML shall not do any operational work for which a CRO is responsible.
  • In case the CML will also become the clinical apheresis specialist:
    • The CML/Apheresis expert will be involved in designing procedures in the trials related to apheresis
    • The CML/Apheresis expert will become the SME for all processes around the collection of patient and donor cells

CANDIDATE PROFILE

  • Minimum of 4 years of experience as a Clinical Research Associate
  • In-depth monitoring experience (in Biotech/Pharma) and in case of also becoming the apheresis specialist: experience as a nurse in a hospital
  • Demonstrated understanding of the processes and environment of the hospitals
  • Articulate, self-motivated,  and ability to effectively communicate orally and in writing
  • Ability and experience excelling in a team-based, collaborative environment
  • Must be comfortable in discussing and resolving issues with research professionals
  • Willingness to travel (max 50%, mainly within Europe)
  • Full-time availability
  • English fluent, Italian/Polish/Hebrew is a bonus
  • People and project management skills are a big plus

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 a competitive remuneration package, the opportunity for personal development and to contribute to make a huge difference for patients.

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

 

Acquisition (by recruitment agencies) will not be appreciated. Any unsolicited CV’s received by agencies will be treated as direct Kiadis applicants – without any fee obligations.

 

 

 

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
recruitment@kiadis.com