| || 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 team provides compliance, operational, sample plan-ning/coordination, vendor management, scientific and data monitoring capabilities for biomarkers to other internal NIBR Novartis functions, such as Biomarker Development and Translational Medicine
The successful candidate will:
1. Develop and provide operational reviews of clinical study protocol, site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample logistics including study setup, sample tracking/reconciliation, assay set up and sample/data upload
2. Place, implement and monitor biomarker assays at external service pro-viders (ESP) in one or more biomarker modalities (broader scope for sen-ior candidates) including Immunoassay, LC-MS, Flow cytometry, etc in TM clinical studies (global and complex studies for senior candidates). Oversight and support include vendor management, sample management, scientific data monitoring, clinical site training and contributions to clinical teams.
3. 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
4. Ensure quality and compliance of US based and global external service provider (ESP) and their deliverables. Independently contribute to the External Service Provider (ESP) management (e.g. ESP assessment, ESP interfaces, regulatory compliance and oversight), sample management and biomarkers (e.g. assay and clinical study set up, data flow, troubleshooting, etc)
5. Independently identify, escalate and resolve complex assay troubleshoot-ing (independent troubleshooting/ resolutions for senior candidates), sample management, ESP, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed.
6. Lead root cause analysis and device creative and novel system solutions. Collaborate with internal functions, clinical teams, sites, and ESPs to de-velop and improve processes (global and complex processes for senior candidates).
7. Serve as Biomarker Expert (BME) in global TM clinical studies contribute to the biomarker strategy and the study design (independent BME contri-butions for senior candidates)
8. Collaborate with other TM and BMD functions and lead site processes and continuous improvement initiatives and innovations
| || The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. |
| || Minimum: BS in life science with 7+ years of experiences or advance degree with 3-5 years in clinical operations and/or clinical bioanalysis
Desirable: training/experiences in global clinical study operation, vendor management and/or laboratory experience
1. Strong scientific knowledge of clinical operations, clinical sample anal-ysis and managing external service provider (ESP). Track record of independent contributions to clinical studies and clinical operations is required.
2. Laboratory knowledge of immunoassay and/or bioanalysis and/or cellular biomarkers is needed. Experience working with ESP and monitoring biomarker work at external service providers (ESP) and data flow (LIMS, DTS, etc) is highly desired. Knowledge of multiple technologies (e.g. mass spec, FACs, etc), platforms and clinical biomarkers is desired for senior candidates. Method development and troubleshooting experiences for complex assays is a definite plus.
3. Knowledge of the drug development process, biomarkers and working with translation clinical research
4. Ability to work effectively under deadlines and high pressure and resolve complex issues with many global projects and clinical teams across multiple R&D sites. Experiences with root cause analysis related to bio analytical work and design of system solutions.
5. Potential, and willingness, to develop skills in new areas and lead new strategic initiatives
6. Strong global project management, problem solving, influencing, communication and leadership skills.