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Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II)

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II).

Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II)

As Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II) your daily tasks and responsibilities will include but not be limited to the following:
• Develop and provide operational reviews of global clinical study protocols, site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample logistics including study startup/setup, sample tracking/reconciliation, assay set up and sample/data upload. You may also serve as a SME in one more operational areas.

• Independently place, set up, implement and monitor “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. You may also serve as a Subject Matter Expert (SME) in one of the biomarker modalities.
• 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.

Minimum requirements:
What you will bring to the role:

• BS in life science with 5+ years of experiences or advance degree with 2 years in clinical operations and/or clinical bioanalysis as well as training/experiences in global clinical study operation, clinical imaging and vendor management and/or laboratory.

• Strong scientific knowledge of global study start up, 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 e.g., GCP, GLP, etc.

• Strong global project management, problem solving, influencing, communication and leadership skills.

• Fluent in English as working language.

• Understanding of central lab operations.

• Laboratory knowledge and subject matter expertise in one or more technologies (e.g., Immunoassay, Imaging, Tissue Biomarker, etc.) is strongly preferred.

Upload your CV/resume or any other relevant file. Max. file size: 128 MB.

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