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Imaging Operations Manager New Jersey
6/22/2016 6:16 AM

The Imaging Operations Manager operationally supports and executes the imaging plans outlined in study protocols, management of imaging CROs, and the preparation of scope of work, imaging charters and other related documents, and support imaging data transfer and reconciliation. 1. Provide integrated and effective operational support to the CTHs or designee for imaging in Oncology clinical   ...View Job
Clinical Trial Head - Global Medical Affairs - Oncology New Jersey
6/21/2016 6:31 AM

The Clinical Trial Head is responsible for management of all aspects and ensuring high quality of assigned clinical trials (phase I-IV, Expanded Access, registries, and Compassionate Use) including leading Clinical Trial Team(s) (CTT). Conducts required tasks in collaboration with GBMD and other line functions. Responsible for program level activities as assigned with an entrepreneurial approach w  ...View Job
Global Program Regulatory Manager (Senior Regulatory Mgr / Assoc Dir) Massachusetts
6/20/2016 6:54 AM

The Global Program Regulatory Manager (GPRM) provides regulatory leadership for early projects in the Oncology Translation Medicine (TCO) portfolio. This individual functions as a core member of Early Program Teams (EPT) to define the optimal regulatory strategy for first in human (FIH) and proof of concept (POC) studies that also enables full development. The GPRM serves as a regulatory expert fo  ...View Job
Trial Operations Franchise Manager New Jersey
6/20/2016 6:54 AM

The TOM Franchise Manager be accountable for the delivery of portfolio of trials from recruitment to quality execution for assigned Oncology Franchise and Compounds, in collaboration with regions and CPOs and in compliance with Novartis processes, GCP/ICH and regulatory requirements. Scope of activities range from start-up to close-out including strategic and operational planning by indication, fe  ...View Job
Sr Data Manager New Jersey
6/20/2016 6:54 AM

Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines. Serve as Trial Data Manager for multiple trials and may act as a PDM for small study programs; Provide input on CTT(s)/GCT (s). Assist Project Data Manag  ...View Job
Clinical Trial Head - Global Medical Affairs - Oncology New Jersey
6/17/2016 6:57 AM

Responsible for management of all aspects and ensuring high quality of assigned clinical trials (phase I-IV, Expanded Access, registries, and Compassionate Use) including leading Clinical Trial Team(s) (CTT). Conducts required tasks in collaboration with GBMD and other line functions. Responsible for program level activities as assigned with an entrepreneurial approach which requires the abilit  ...View Job
Sr Data Manager Massachusetts
6/17/2016 6:57 AM

Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines. Serve as Trial Data Manager for multiple trials and may act as a PDM for small study programs; Provide input on CTT(s)/GCT (s). Assist Project Data Manag  ...View Job
Assoc Director / Director Pharmacometrics (Modeling and Simulation) New Jersey
6/16/2016 6:15 AM

Job purpose: Support oncology drug development by providing clinical pharmacology/DMPK/pharmacometric expertise across early and full development phases, and global medical affairs, with a Pharmacology Focus or a Pharmacometrics Focus or some mixture thereof. Support project teams with modeling- and simulation-based input to clinical trial design, evaluations, integrated analysis, and repor  ...View Job
Sr Biostatistician New Jersey
6/15/2016 11:08 AM

The Biomarker Data Analyst contributes to drug development efforts by providing high-quality and timely statistics and bioinformatics expertise in the areas of Biomarker data analysis, integration and interpretation.Provide high added value to BDB components of drug projects: • Analyze biomarker data from Novartis clinical trials according to specified timelines and report findings ba  ...View Job
Submission Writer New Jersey
6/9/2016 8:08 AM

The Submissions Writer writes, edits and /or manages the production of high quality clinical documentation for HA submissions. Responsibilities: • Responsible for production of high quality clinical documentation: Clinical Study report, Risk Management Plan, CTD submission documents (summary of clinical efficacy and safety, and efficacy and safety updates). • Acts   ...View Job
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