Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Senior Manager, Clinical Research

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our St Paul or Plymouth, MN, location, supporting our Electrophysiology medical device division. Senior Manager, Clinical Research will lead scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area.

This position will manage the development of clinical plans, within timelines and budget, with the goal of generating clinical evidence.  This evidence will establish feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and support full commercial adoption of medical devices.  You will manage a team of scientists who support the analysis and interpretation of scientific data and write clinical study protocols, reports, and scientific publications. Your team is responsible for 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.

What you'll work on

Identifies personnel gaps within the team and provides recommendations of solutions to the Director.Involved in candidate selection (sourcing, interviews, etc.)Assists in developing the training and educational plans for these individualsManagement of personnel development, mentoring and effective delegation to direct reports to meet program goals.Oversee performance management process for the team.Effectively manages team members and deliverables in times of conflict, uncertainty and crisis, and resolve issues in a timely manner in conjunction with functional management.Appropriately disseminates feedback from governance bodies and the functions to the team and extended organization.Leads and motivates functional area teams to meet key project deliverables and timelines by developing effective technical strategies and executionAccountable for strategy development and execution for specified clinical area.Fosters creative thinking, innovation, knowledge sharing and reasoned risk-taking.Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to senior staff.Ensures appropriate review and refinement of project plans by functional area management and staff.Effective coordination of and communication with all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.Clearly communicates project/program recommendations and decisions to various stakeholders within the team, functional areas, R&D, and commercial management.Critical review of vendor proposals and contracts to include potential CRO agreements and medical writers to ensure program success. Financial approval of contracts and expenses at specified level.Develops and maintains current, in-depth, relevant functional knowledge (such as scientific, technical and regulatory aspects) of projects in support of the diagnostic area on a global basis.Builds and maintains relationships with key experts and professional organizations that further the effective development of the product and maximize product potential.Attends and adds management presence to key Investigator/Customer meetingsDrives short- and long-term project success by managing and monitoring the functional components of worldwide projects such that scientific, regulatory, legal, financial, commercial and quality requirements are met in consideration of time and resource constraints as well as environmental uncertainties while operating by and within standardized procedures established within the function.Uses thoroughly analyzed data, due diligence, and input from internal and external functional experts to drive a rigorous decision-making process that appropriately incorporates underlying assumptions, risks and benefits, probabilities of success, timelines, and resource requirements.General back up to Director when he/she is unavailable, vacation etc.Budgetary responsibility as directed by your manager.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Required Qualifications:
 

Advanced degree, or relevant experience, in the sciences, medicine, or similar discipline.5+ years of clinical research work experience post-degree.Experience writing and designing study protocols.Excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Familiarity with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.Strong organizational and follow-up skills, as well as attention to detail.Ability to travel 20%Management experience.

Preferred Qualifications

Experience in the medical device industry.Experience with international medical device regulations and submissions.Electrophysiology experience.Experience working in a quality system environment.

Apply Now

 

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $111,300.00 – $222,700.00. In specific locations, the pay range may vary from the range posted.