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. Up to 30% domestic travel is required.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in our talent hub in Irvine, CA. 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
The Senior Clinical Research Scientist will be responsible for:
- Clinical Research Portfolio management within designated Operating Company, as well as, fostering strong, productive relationships with colleagues within the organization.
- Front end activities related to product development and clinical feasibility, including literature reviews with minimal direction.
- Complete required templates and documents, and maintains records related to assigned projects. Participate in product development Project Core Team (PCT) activities, and provides input and completes clinical tasks and with minimal supervision.
- Participate in formulating evidence generation strategies with input from Medical Affairs.
- Verify milestones and track payments for assigned Operating Company-managed projects.
- Develop strong collaborative relationships with Study Core Team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
- Draft clinical trial protocols with supervision.
- Conduct literature reviews and draft study reports for assigned studies to include any unanticipated adverse event reporting, annual reports, study close out reports, as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions, with supervision.
- Develop materials to be used by Clinical Operations for study execution (Investigator Brochures, training materials, etc.).
- Support the implementation of new clinical systems/processes.
- Develop high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs.
- Develop a strong understanding of the Operating Company product portfolio and pipeline.
- Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
- Support publication strategy execution including collaboration with investigators and internal stakeholders.
- Determine fair market value (FMV) and plan for study budgets under direction of senior clinical leaders. Assist with the review of clinical information required for periodic safety and post-market surveillance reviews in collaboration with Medical Affairs.
- Provide leadership to Clinical Study Core Teams.
- Consistently strive to improve the performance, reputation, and image of the clinical organization. Ensure efficient use of resources to provide high quality deliverables.
- Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. Provide quality feedback to the Directors and Managers of each resource assigned to clinical studies regarding employee performance within the context of the clinical studies.
- May be asked to provide training to employees or other individuals and/or group as needed.
- A minimum of a Bachelor’s Degree with at least 6 years of clinical or related technical experience is required.
- A Master’s degree or PhD/MD/PharmD is preferred.
- A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
- Knowledge of Good Clinical Practices is required.
- Understanding and application of regulations and standards applied in clinical areas is required.
- The ability to influence others along with strong written and oral communication skills is required.
- Advanced project management skills with the ability to handle multiple projects are preferred.
- Medical device experience is preferred.
- Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE).
United States-California-Diamond BarOther Locations
North America-United States-California-IrvineOrganization
Biosense Webster Inc. (6010)Job Function
Clinical Trial Administration
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