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Form of workBiosense Webster, Inc. is currently recruiting for a Senior Clinical Strategic Operations Specialist. This role will work a Hybrid/Flex schedule and must live within a commutable distance to Irvine, CA .
At Biosense Webster, Inc. we have one goal - to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.
Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.
Learn more about Biosense Webster at www.biosensewebster.com
Reporting to Clinical Science and External Research Leaders, the Senior Clinical Strategic Operations Specialist will handle external research programs, including the Investigator-Initiated Study Program, to support the evidence generation and dissemination strategy of assigned products. This person will support clinical study coordination and other research-related tasks to support applicable Company and Departmental procedures.
Key Responsibilities :
• Coordinates postmarket clinical studies, including company-sponsored studies, investigator-initiated studies, and collaborative studies.
• Leads the Investigator-Initiated Study Program, including working with external investigators and internal teams to handle the flow of applications through the review/approval process and securely maintaining records.
• Coordinates the execution of approved studies, including: confirming incorporation of specific conditions in the study protocol and contract; working with appropriate contracting groups, such as Contract and Compliance Services, to document that the Fair Market Value of the final budget is at or below the budget maximum approved by the Committee; establishing final timelines with the Investigator and confirming alignment with the original application; and verifying that all study conditions have been met prior to study closeout.
• Serves as the Clinical Science & External Research contract specialist responsible for: crafting study-specific budget and payment schedule; drafting the clinical study agreement in consultation with the appropriate study manager; collaborating closely with the site regarding clinical study agreement negotiations; coordinating Legal, Healthcare Compliance, and other appropriate department reviews; handling execution of final clinical study agreement by both sponsor and site; and uploading the fully implemented contract onto the contract management database.
• Schedules meetings, accurately drafts and records meeting minutes, and follows-up on action items.
• Works with global Medical/Clinical colleagues in daily management of research projects in countries outside of the United States.
• Handles device orders, shipments, and returns.
• Maintains the internal clinical evidence database and assists with monthly literature reviews.
• Runs Clinical Events Committees for assigned clinical studies.
• Coordinates investigator meetings.
• Helps Clinical Scientists with tracking publication development activities.
• Communicates business-related issues or opportunities to Management.
• Updates leadership on investigator-initiated study and collaborative study progress.
• Ensures personal and Company compliance with all Government and Company regulations, policies, and procedures.
• Performs other assigned duties, as needed.
The base pay range for this position is $90,000 to $125,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.Minimum Qualifications :
• Bachelor's degree in a relevant scientific field required.
• Minimum of 2 years of experience in clinical study management in Medical Device, Pharmaceutical, Biotechnology, or Clinical Research Organization industries.
• Effective time management, organizational and prioritization skills.
• Strong project management skills with meticulous attention to detail.
• Professional verbal and written communication skills.
• Proven record of collaborating in a cross-functional work environment.
• Highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of their contributions to the advancement of the collective Clinical Science & External Research goals and objectives.
• Medical device experience; cardiovascular experience is a plus .
• Experience with clinical research contract negotiation preferred .
• Experience interacting with external investigators desired .
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
