550. That's the number of concurrent clinical trials that Novartis is sponsoring at any given time.
Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis committed to discovering innovative medicines that treat disease and improve human health. Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and NIBR Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO is working in close collaboration with clinical teams, LF technology experts, Biomarker Experts (BMEs) as well as external service providers (ESP) including central labs and clinical sites. LEO motto and drive is "Right samples, right lab, right time and right quality".
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 start up/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. Flow cytometry, Immunoassay, LC-MS, genetics 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. Independently lead the development of new ESPs, including on qualification, on boarding, communication, and oversight.
* 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 and BMD.
* Serve as Biomarker Expert (BME) in global TM clinical studies and contribute to the biomarker strategy and the study design