Senior Clinical Research Scientist

Abbott • Plymouth, MN

2d • $78,000 - $156,000 • Onsite

About The Position

This position works out of our St Paul or Plymouth, MN locations, supporting our Electrophysiology medical device division within the Clinical Affairs function. The Senior Clinical Research Scientist will lead scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area. This position will participate in the development of clinical evidence to establish feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and support full commercial adoption of medical devices. You will support the analysis and interpretation of scientific data and write clinical study protocols, reports, and scientific publications. You will aid in the production of additional study-level documents including informed consent forms, case report forms, and investigator brochures. In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Field Operations, Risk Management, Reimbursement, Medical Affairs, Quality, and Regulatory Affairs. You will also interact with global regulatory agencies to obtain market approval of new products, and with study sites to respond to questions throughout the study.

Requirements

• Advanced degree in the sciences, medicine, or similar discipline.
• 4+ years of clinical research work experience post-degree.
• Demonstrated scientific writing ability.
• Ability to plan and organize project assignments of substantial variety and complexity.
• Ability to be innovative, resourceful, and work with minimal direction.
• Excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

• Experience in the medical device industry.
• Experience with international medical device regulations and submissions.
• Familiarity with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Experience working in a quality system environment preferred.

Responsibilities

• Participate in clinical trial design, protocol development, and publication planning.
• Generate and execute on study-level publication projects.
• Prepare clinical study reports or report sections.
• Support regulatory submissions.
• Facilitate communication between Sales and Marketing, R&D, Program Management, Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and investigational sites.
• Oversee study Steering Committees and Publication Committees, consisting of physician Key Opinion Leaders globally.
• Present clinical study results to senior leaders and at investigator meetings.
• Participate in and support audits.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior