Program Manager, Clinical Risk Management

Company: Abbott Laboratories
Location: Santa Clara
Posted on: February 22, 2021

Job Description:

Program Manager, Clinical Risk Management Medical and Clinical Affairs United States - California - Santa Clara 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 109,000 colleagues serve people in more than 160 countries. For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks. Our locations in Santa Clara, CA or Sylmar, CA currently have an opportunity for a Program Manager, Clinical Risk Management. WHAT YOU'LL DO In this role, you will provide technical and strategic expertise throughout the product development and life cycle process; daily activities are related to management and alignment of risk information for Vascular and CAHF products. The Program Manager writes and manages risk master lists, product safety update reports (PSURs), performs risk analysis, and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines.-- Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, EU and FDA guidance documents) and DOPs. Develop and maintain Risk Master List (RML) DOP, Periodic Safety Update Report (PSUR) DOP and associated documentation, provides input to cross-departmental SOPs and DOPs describing risk information processes. Develop templates taking into account all applicable regulations. Provide and implement innovative ideas and solutions to Clinical Risk Evaluation group (e.g. database, LEAN projects), develop and roll out functional trainings as required. Independently create and maintain RMLs and PSURs for Abbott products. Maintain thorough knowledge of assigned products. Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references. Oversees CROs, actively manages timelines and project delays/risks, develops scenario's and recommendations for management. Lead risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitate informed decision-making and dissemination of scientifically balanced and quality risk information regarding products. Ensure effective communication to clinical safety, clinical science, clinical internal and external operations, product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product labelling, senior management, and external CROs or medical writers. Conduct team meetings, send routing communications and/or present regular updates to senior staff. Review IFUs, patient guides, Risk Management, Clinical Evaluation Protocol, Clinical Evaluation Report (CEP/CER), IBs, study protocols, study ICFs, physician training materials, ensuring alignment of risk information. Involve in responses to complex costumer queries (e.g. regulatory authority, ethical committee, ---) related to risk information. Review and give input to Post-Marketing Surveillance Plans (PMS) and Post-Marketing Clinical Follow-up Plans (PMCF). Create and update PSURs for assigned product families Facilitate regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Performs proactive clinical trial signal detection (planning, execution, and presentation) and actively participates in clinical corrective action board meetings Participate in and support audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring, as requested by management Acts as a mentor to less-experienced staff Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, EU and FDA guidance documents) and DOPs. EDUCATION AND EXPERIENCE YOU'LL BRING Required Biomedical or medical degree or an equivalent combination of education and work experience Minimum 5 years of experience in a medical device clinical research, medical writing, or combination of these skills WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Get tailored job recommendations based on your interests.
  • JOB ID: 30971244
    • LOCATION United States - California - Santa Clara
    • ADDITIONAL LOCATION United States - California - Sylmar
    • DIVISION MD Medical Devices
      • TRAVEL Yes, 5 % of the Time
        • MEDICAL SURVEILLANCE No
          • SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday) Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.-- GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future. TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.-- WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE ---------------------THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities.-- Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Santa Clara , Program Manager, Clinical Risk Management, Executive , Santa Clara, California