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Senior Clinical Research Scientist
Clinical Research non-MD
Requisition ID: 1994180129
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Clinical Research Scientist aligned to Biosense Webster, located in Irvine, CA.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more at Biosense Webster at www.biosensewebster.com
On behalf of the Medical Device Group, this clinical research professional will contribute to the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.
The Senior Clinical Research Scientist will:
· Contribute to the development and delivery of appropriate global EGS / EDS to support NPD and LCM within the assigned projects;
· Contribute towards development of clinical trial protocols, informed consents, investigator brochures, and other study materials;
· Plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures;
· Contribute to delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP);
· Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders;
· Draft study reports for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions;
· Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
· Contribute in the interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and use of clinical data/evidence for market access and reimbursement;
· Support the collaboration with investigators to deliver and disseminate evidence;
· Ensure appropriate study registration from study initiation through posting of results;
· Develop a strong understanding of the pipeline, product portfolio and business needs.
· Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
· May be involved in other tasks to support clinical research activities as needed.
· Generally manage work with supervision, dependent on project complexity. Independent decision-making for simple situations but requires guidance for complex situations. Senior staff member will review work during development, dependent on level of complexity, and upon completion.
• Bachelor’s degree in Biological Science or related discipline, with a minimum of 4 years related scientific / technical / clinical research experience or Masters or PhD these requirements with a minimum of 2 years related experience is required.
• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required.
• Ability to provide scientifically strategic and evidence based input across NPD and LCM projects is required.
• Proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required.
• Ability to lead small study teams, to deliver critical milestones is preferred.
• Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc), and meet business objectives is required.
• Ability to collaborate across different functional areas within the business to complete project deliverables and meet business objectives is required.
• Develop ability to build collaborative relationships with key internal and external partners and stakeholders is required.
• Knowledge of Good Clinical Practices (GCP) is required.
• Literature reviews and research experience is required
• Knowledge of protocol, informed consent, and CRF development is required.
• Experience leading and writing a protocol and/or investigative brochure is preferred.
• Up to 20% travel, both domestic and international is required.
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD