Clinical Research Leader |

hace 4 días

Madrid, España Empresa Reconocida A tiempo completo

.Biosense Webster Inc.is recruiting for a Clinical Research Leader, located in Irvine, California.This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.Key Responsibilities Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones.Oversees/executes feasibility, selection, setup, conduct, and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.May serve as the primary contact for clinical trial sites.Develops clinical trial documents (e.G., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).Ensures applicable trial registration from study initiation through posting of results and supports publications as needed.Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.Interfaces, collaborates and oversees Clinical Research Associates (CRAs).Oversees and supports the development and execution of Investigator agreements and trial payments.Is responsible for clinical data review to prepare data for statistical analyses and publications.May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close-out visits based on study need.May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS).May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments.Supports planning, tracking and managing assigned project budgets to ensure adherence to business plans.Supports clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.May serve as the clinical representative on a New Product Development team.May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports

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