Job Details

ID #49591447
State South Dakota
City Pierre
Full-time
Salary USD TBD TBD
Source J&J Family of Companies
Showed 2023-03-30
Date 2023-03-31
Deadline 2023-05-30
Category Et cetera
Create resume

Principal Clinical Research Scientist

South Dakota, Pierre, 57501 Pierre USA

Vacancy expired!

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 expired!

Subscribe Report job