Global Trial Manager - Biomarker Project Manager- Novartis: UK homebased

Global Trial Manager - Biomarker PM - Novartis dedicated

Supports operational and some scientific aspects of global clinical trial(s), under the management of the (Associate) Global Trial Director. Core member of the Clinical Trial Team.

Your responsibilities:

1. Support individual clinical trial teams (CTTs) and Precision Medicine teams as required for all technical and operational biomarker-related matters for assigned projects by collaborating closely with internal partners. Assist in forecasting the biomarker operational costs and reviewing invoices.

2. Provide input on diagnostic and biomarker sections in clinical trial-related documents (such as protocols and consents) under the supervision of the LF representatives. Provide clinical operational support for companion diagnostic activities, as needed. Partner with Precision Medicine Leads, study biostatisticians, and labs to establish biomarker and diagnostic analysis plans.

3. Responsible for all clinical biomarker tracking processes, including setting up laboratory procedures, tracking biomarkers from collection to analysis, and assisting with the relevant data management components.

4. With support, provide input and solutions on the ethical considerations for biomarker collection and analysis for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.

5. With support, establish central and analysis laboratory components for assigned studies. Lead all aspects of central labs and analysis labs for biomarker and diagnostic sample collection kits and sample logistics. Responsible for all of the documentation required to set up central and analysis lab procedures.

6. Define biomarker and diagnostic needs for the case report forms (CRFs) and data transfer in collaboration with LF representatives, (a)GTD, trial data manager (TDM) and analysis labs; With support, collaborate closely with the TDM, database developer, and labs for data transfer and data reconciliation. Review transferred data to ensure quality.

7. Develop, with assistance, training material on the technical aspects of biomarker and diagnostic collections for the clinical trial sites, including study specific lab manuals and additional site and monitor training needs. May also be involved in training of monitors and site personnel.

Minimum requirements

• What you’ll bring to the role:
  Education:
  M.S. or M.A. in a life science is strongly preferred.
• 
  Experience:
  • Senior must have at least 2 years of experience handling clinical samples.
  • Familiarity with biomarker discovery methodologies, assay technologies and molecular biology.
  • Basic knowledge of oncology or hematology strongly preferred.
  • Knowledge of Good Clinical Practice.
  • Knowledge of clinical trial design; understanding of the overall drug development process.
  • Excellent organizational and communication skills.
  • Ability to handle multiple competing priorities and meet timelines.
  • Proven networking skills and ability to share knowledge and experience amongst colleagues.

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