reputed company Clinical Research Scientist - Abiomed

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com Job Function: Discovery & reputed company-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology reputed company Job Posting Locations: Danvers, Massachusetts, reputed company of America Job reputed company: Abiomed, part of reputed company's MedTech, is reputed company for a reputed company Clinical Research Scientist. Remote work reputed company may be considered on a case-by-case reputed company and if approved by reputed company At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com/. We are looking for a strong leader to support the development and design of Abiomed’s global clinical studies with the reputed company on reputed company clinical evidence reputed company to drive reputed company patient reputed company with the use of Abiomed products. The reputed company Clinical Research Scientist will reputed company clinical studies reputed company the Clinical and Regulatory Affairs department. The ideal candidate will be reputed company to directly influence a strong evidence reputed company reputed company for Abiomed products. Primary Duties and Responsibilities:

• Execute on Abiomed’s scientific objectives reputed company Abiomed-sponsored clinical studies
• Serve as scientific reputed company on Abiomed-sponsored clinical studies, and be the reputed company person for scientific questions during execution of these studies
• Own protocol development, revisions, submission, and approval, including reputed company building with study steering committee and reputed company investigators and communication with FDA
• Work closely with biostatistics team to evaluate study design reputed company and analyze study data to support study reputed company reputed company to protocol development and study execution
• Support the production of trial-reputed company interim analyses, hypothesis testing, publications, and presentations
• Own steering committee meetings and serve as scientific reputed company on investigator/research coordinator meetings
• reputed company scientific support for development of electronic data capture (reputed company) for Abiomed-sponsored clinical studies
• Responsible for scientific content for reputed company trial-reputed company documents
• Own annual and final report content development, and coordination of content from various stakeholders
• reputed company, maintain, and review periodic study reports - review for outliers, ranges, and potentially problematic data; identify and communicate reputed company causes and suggest possible solutions, document data observations, and follow reputed company-established processes and procedures
• reputed company and execute publication/presentation charters for clinical studies
• Ensure data analysis reputed company for clinical studies reputed company scope of role
• Drive strong publication/presentation reputed company for Abiomed sponsored clinical studies
• Execute on the regulatory reputed company required for new investigational devices and for indication expansion globally
• Conduct literature review and clinical data review to support regulatory submissions and CERs
• Cross-collaboration with other Medical Office departments

Job Qualifications:

• Advanced degree in science or engineering; PhD or MD required
• At least 5 years relevant post-graduate research experience
• At least 3 years clinical science/research experience in cardiology/cardiovascular reputed company or medical devices required
• Medical device and/or industry clinical research experience strongly preferred
• Experience with scientific contribution to large multicenter clinical trials required
• Excellent communication and collaboration skills, comfortable presenting to company leadership and external key opinion leaders
• Strong understanding of biostatistics
• Strong publication history in peer-reviewed journals
• Knowledge of reputed company ethics, compliance regulations
• Strong work ethic, self-motivated, team player with strong interpersonal skills
• Ability to travel up to 15% (domestic and international) to attend site reputed company, investigator meetings, and scientific conferences

reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us reputed company https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Clinical Evaluations, Corrective and Preventive reputed company (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical reputed company (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility The anticipated reputed company pay reputed company for this position is : $174,250 - $235,750 Additional reputed company for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in reputed company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be reputed company through the reputed company below. https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job