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Translational Project Manager




Cambridge, Massachusetts, United States

Over 35 preclinical targets in our pipeline! Novartis Institutes for Biomedical Research (NIBR) Oncology strives to reimagine medicine for cancer patients through a combination of targeted immunotherapies including CAR-T, immune cell-engager, antibody drug conjugate and radioligand therapy. <br><br>The Translational Clinical Oncology team is looking for a Translational Project Manager to Lead the implementation of the biomarker strategy by providing project and vendor management support to assure the timely delivery and quality of biomarker data in oncology clinical trials. <br><br>What you will be doing: <br><br>•Provide project management support of the clinical teams’ requirements for i) new biomarker assay research, development and validation, ii) biomarker clinical testing, iii) review of assay specific performance data, iv) data visualization and interpretation. <br>•Provide input to study concept review board submissions to ensure biomarker assessments are operationally feasible. Responsible for reviewing biomarker relevant sections of clinical protocols and review of ICF template. Ensure line function head approval prior to submission to the protocol review committee (PRC). <br>•Ensure local data and biomarker sample collections are captured appropriately in the CRFs. Provide input for biomarkers into other clinical trial documents e.g. SAP, Data Review Plan, CSR and central lab documents including standardized sample collection instructions. <br>•Liaise with clinical teams to discuss data reporting requirements (format, content and agreed transfer process) to ensure that appropriate data transfer specifications are agreed prior to the start of clinical testing. <br>•Provide feedback via the clinical team to study sites/IRB’s/Health Authorities on biomarker operational questions including generation of training materials for sites.<br>•Collaborate cross-functionally (e.g. QA) and cross-divisionally (e.g. EDO, NBS) to ensure compliance with Novartis quality systems for selecting and managing external vendors for clinical trials. <br>•Identify appropriate vendors and coordinate meetings to discuss vendor proposals. Work with vendor, clinical teams, and subject matter experts (SMEs) to ensure appropriate plan and budget is in place. <br>•Coordinate the technical assessment process with the respective SME maintaining the assay and biomarker portfolio information in appropriate repository (e.g. BLPT, TCB SharePoint.)<br>•Drive the biomarker outsourcing process through effective vendor management and project oversight (business conflicts, project status, adherence to budget, periodic provider appraisals, etc.) and resolve issues or escalate in a timely manner as necessary. <br>•Facilitate the review of biomarker data by the clinical teams and SMEs both for internal review (e.g. CTT, EPT, translational science meeting) and externally (e.g. in dose escalation meetings) by ensuring biomarker data is available in-house and working with stats /SMEs/ bioinformatics on appropriate biomarker data outputs. <br><br>This role can be site based in Cambridge, MA or East Hanover NJ. It will not have the ability to be located remotely.<br><br>[#video#{#400,300#}#/video#]