Responsible for the operational implementation of the clinical study strategy related to bi-osamples, including pre-selection, pharmacodynamic, predictive, and safety markers and PK samples, in collaboration with line function (LF) representatives. Accountable for the timely op-erational execution of these assessments in protocols, in compliance with Novartis processes and regulatory requirements.
1. Support individual clinical trial teams (CTTs) and Biomarker Sub-teams as required for all technical and operational biosample-related matters for assigned projects by liaising with in-ternal stakeholders. Assist (Associate) Global Trial Director ((a)GTD)by forecasting the bi-osample operational costs and reviewing invoices.
2. Provide input on biomarker and clinical pharmacology sections in clinical trial-related (such as protocols and consents) and regulatory documents (such as INDs, IBs, etc.) under the su-pervision of the LF representatives.
3. Responsible for all clinical biosample tracking processes, including setting up laboratory pro-cedures, tracking clinical biosamples from collection to analysis, and assisting with the rele-vant data management components.
4. With support, provide input and solutions on the ethical considerations for biosample collec-tion 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. Oversee central labs and analysis labs for clinical, biomarker and PK sample collection kits and sample logistics. Responsible for all of the documentation required to set up central and analysis lab procedures.
6. Liaise with internal stakeholders, and the CTT to determine analysis labs for biomarkers and other clinical biosamples. Manage relationships with analysis labs and provide input into tri-al-specific agreements, following the standard process.
7. Define biosample needs for the case report forms (CRFs), in collaboration with LF represent-atives, (a)GTD, trial data manager (TDM) and analysis labs; and for data formatting and data transfer set-up needs for samples. With support, liaise with the TDM and labs for data trans-fer and data reconciliation.
8. Partner with Precision Medicine Leads, study biostatisticians, and labs to establish biomarker analysis plan; under guidance, review transferred data to ensure quality.
9. Develop, with assistance, training material on the technical aspects of clinical biosample col-lections for the clinical sites, including study specific lab manuals and additional site and monitor training needs. May also be involved in training of monitors and site personnel.
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.
M.S. or M.A. in a life science is strongly preferred.
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.
Basic knowledge of clinical trial design; understanding of the overall drug development process.
Excellent organizational and communication skills.
Ability to manage multiple competing priorities and meet timelines.
Proven networking skills and ability to share knowledge and experience amongst colleagues.
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