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: 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 (e.G., site management).
Develops clinical trial documents (e.G., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Ensures applicable trial registration (e.G., on ) from study initiation through posting of results and support 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), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.G., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc.
), contributing to cross-functional alignment.
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 the delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget, and in compliance with regulations and SOPs).
Supports planning, tracking, and managing assigned project budgets to ensure adherence to business plans.
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