Biomarker Scientific Monitor & Study Coordinator

Highly Competitive
  1. Contract
  2. Informatics
  3. Switzerland
Basel, Schweiz
Posting date: 27 Jun 2024
61146

Proclinical is working with a major Pharma client based in Basel, Switzerland who is offering a 12 months assignment for a Biomarker Scientific Monitor role.

Proclinical is aiming at EU / Swiss nationals / Swiss permit holders with working experience as Biomarker specialist. Unfortunately, sponsorship is not available for Switzerland.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Advance and issue operational evaluations of clinical study procedures, site operations manuals.
  • Place, construct, implement and maintain "fit for purpose" complex biomarker assays at external service providers (ESP) in one or several biomarker modalities (e.g, Imaging, Tissue Biomarker, Immunoassay, etc .) in TM clinical studies.
  • Support data transfer and data flow in LIMS and DTS (e.g., study creation, data flow, data transfer, etc.) for managed biomarkers and studies.
  • Update study and project information in relevant IT systems.
  • Ensure quality and compliance of global external service provider (ESP) and their deliverables.
  • Identify, escalate and resolve complex assay troubleshooting, sample management or ESP issues, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed.
  • Collaborate with other TM and BMD functions and lead clinical site processes, continuous improvement initiatives and innovations in LEO.

Key Skills and Requirements:

  • BS in life science with proven experience in clinical operations or clinical bioanalysis as well as training/experiences in global clinical study operation, clinical imaging and vendor management and/or laboratory.
  • Deep scientific understanding of start up for global study, clinical operations, clinical sample analysis and management of external service provider (ESP).
  • Proven track record of independent contributions to global clinical studies and clinical operations is required.
  • Experience working with ESP and monitoring biomarker work at external service providers (ESP) and data flows (LIMS, DTS, etc.).
  • Method development and troubleshooting experiences for complex bioanalytical and biomarker assays.
  • Knowledge of the drug development process and regulatory requirements
  • Strong global project management, problem solving, influencing, communication and leadership skills.
  • Fluency in English is a necessity.

If you are having difficulty in applying or if you have any questions, please contact Joshua Bye on j.bye@proclinical.com.



Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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