Vacancy caducado!
Principal Clinical Research Scientist - 00001J75DescriptionAbiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.I Am Abiomed | I Am Heart Recovery | Patients First!Job Responsibilities: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 generation to drive better patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products.Primary Duties and Responsibilities:
Execute on Abiomed’s scientific objectives within Abiomed-sponsored clinical studies
Serve as scientific lead on Abiomed-sponsored clinical studies, and be the point person for scientific questions during execution of these studies
Own protocol development, revisions, submission, and approval, including consensus 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 related to protocol development and study execution
Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations
Own steering committee meetings and serve as scientific lead on investigator/research coordinator meetings
Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies
Responsible for scientific content for all trial-related documents
Own annual and final report content development, and coordination of content from various stakeholders
Develop, 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
Develop and execute publication/presentation charters for clinical studies
Ensure data analysis integrity for clinical studies within scope of role
Drive strong publication/presentation cadence 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
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; 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
Proficiency in medical terminology, medical writing, experience with following ICMJE guidelines
Strong understanding of biostatistics; ability to use statistical programs such as Matlab, SAS a strong plus
Demonstrated publications in high impact factor peer-reviewed journals
Knowledge of healthcare ethics, compliance regulations
Advanced knowledge of MS Office, Adobe suite
Strong work ethic, self-motivated, team player with strong interpersonal skills
Ability to travel periodically (domestic and international) to attend investigator meetings and scientific conferences
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.Primary Location NA-US-Massachusetts-DanversOther Locations NA-United StatesOrganization Do not use (8535)Job Function Clinical Research non-MDReq ID: 00001J75
Vacancy caducado!