Principal Clinical Research Scientist job at reputed company in Danvers, MA

Title: Principal Clinical Research Scientist - Abiomed Location: Danvers, Massachusetts, United States of America Work Type: Hybrid, Full Time Job ID: R-046412 Job Description: At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, 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 innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - Non-MD Job Category: Scientific/Technology reputed company Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: Abiomed, part of reputed company's MedTech, is recruiting for a Principal Clinical Research Scientist. Remote work options may be considered on a case-by-case basis and if approved by the Company At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, 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 innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. We are looking for a strong leader to support the development and design of Abiomed's global clinical studies with the focus on sound clinical evidence reputed company to drive reputed company patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will reputed company clinical studies reputed company the Clinical and Regulatory Affairs department. The ideal candidate will be able 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 principal investigators and communication with FDA Work closely with biostatistics team to evaluate study design options and analyze study data to support study decisions 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 Provide 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 root causes and suggest possible solutions, document data observations, and follow pre-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 pathway 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 space 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 healthcare 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 visits, investigator meetings, and scientific conferences reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, 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 actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (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 range for this position is : $174,250 - $235,750 Additional Description 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, vision, 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 the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the 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 Sick time - 40 hours per calendar year; for employees who reside 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 Apply tot his job Apply To this Job