Job Description Summary
Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and BR Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication, sample coordination and innovative solutions. LEO is working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs), Data Management as well as specialized external service providers (ESP), central labs and clinical sites.
Job Description
Major accountabilities:
8+ years of clinical operations and/or clinical data management or an advance degree with 6+ years in clinical operations and/or clinical data management
Lead, develop, and implement innovative systems, IT solutions and processes/best practices for clinical sample management and clinical sample metadata flows in global clinical trials, covering exploratory and regulated biomarkers, PK samples, and more.
Act as a global Subject Matter Expert (SME) for clinical sample processes and systems, driving consistent best practices and execution excellence
Provide expert guidance to global clinical teams, biomarker experts, coordinators, and monitors for:
Clinical sample metadata setup with central labs and specialized CROs.
Operations manuals, paper/electronic requisition forms, and sample workflows.
Metadata mapping for LIMS, Data Transfer Specifications, and eCRFs.
In-study and final sample reconciliation.
Update study and sample information across relevant IT systems (e.g., sample tracking platforms) following protocol amendments or reconciliation needs
Oversee and contribute to managing bio-sample operational flows with CROs, external sample storage facility and internal stakeholders to ensure sample handling and processing steps for a range of analytical assays
Provide operational support for clinical studies, including protocol review, biomarker- and PK-related logistics, site operations manuals, informed consent, central lab manuals, and sample tracking
Partner with IT teams to enhance digital systems, and contribute to integration and automation projects supporting data handling and metadata quality
Key performance indicators:
Effective, proactive planning of clinical sample-related operations.
Timely and accurate implementation of systems and processes
Strong feedback from internal and external partners regarding SME support
Demonstrated adherence to Novartis Values and Behaviors.
Job Dimensions:
Number of associates
No direct reports: operates in matrix teams and manages interactions with external CRO partners.
Financial responsibility
Accountable for financial/resource decisions within assigned authority.
Impact on the organisation
Internal: Ensures availability of high-quality biomarker data enabling timely decision-making and regulatory submissions.
External: Contributes to Novartis being perceived as a reliable and innovative partner.
Minimum Requirements:
Education:
Minimum: M. Sc. in Life Sciences.
Languages:
Fluent in English as working language.
Experience / Professional Requirement:
1. Operational knowledge of clinical trials, including study setup, sample management, and clinical sample/data flow systems (e.g., DTS, LIMS, eCRF, eReq)
2. Clinical data management and data review experience highly desirable including knowledge of global clinical IT platforms (Medidata, Veeva, etc)
3. Track record of implementing innovative clinical systems, IT solutions, and digital process improvements is desired
4. Technical curiosity and an appetite for IT to support automation, digital workflow optimization, and effective integration across clinical data systems. Experience with programming (e.g., Python, SQL) or strong willingness to learn and apply programming to support workflow automation and data processes
5. Strong project management, planning, problem-solving, influencing, and communication skills. Experience working in a global, matrixed organization
6. Knowledge of drug development, clinical biomarkers and translational research. Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc
Skills Desired
Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curious Mindset, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (ML), Management, Medical Research, Molecular Biology {+ 10 more}