SENIOR MANAGER, CLINICAL AFFAIRS

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 115,000 colleagues serve people in more than 160 countries.About AbbottDiagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.We currently have an opportunity on our Infectious Disease team for a Senior Manager, Clinical Affairs at either our Lake Forest, IL or Scarborough, ME locations.WHAT YOU’LL DODevelop and execute on clinical strategy to generate data for regulatory, marketing and other purposes.Manage the operation of clinical program(s) to ensure compliance with regulatory requirements.Provide strategic input to clinical trial design and protocol development.Ensure adequacy of data acquisition and management, and timely completion of studies and associated projects.Identify and communicate project objectives, propose innovative solutions to potential obstacles in study conduct, study sites, or with CROs.Ensure adequate study resources to successfully complete clinical project and programs on-time and on-budget.Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines and make recommendations to senior management.Coordinate with departmental teams to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders.Oversee the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management and site selection and recruitment strategies.Oversee vendor and site qualification activities in conjunction with Clinical Quality Assurance.Oversee management and maintenance of Trial Master File.Provide guidance on all clinical operation logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.).Drive the development of SOPs and other procedural documents.Interact with other functional areas and key stakeholders, including Data Management,Finance, Regulatory, R&D, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities.Develop and provide input on CRF development and completion guidelinesDevelop, review, and approve study-related plans, specifications, instructions for use, charters, newsletters, and materials.Participate in data cleaning, listing, and report output reviews.Participate in protocol deviation listing reviews and meetings.Develop presentations for management updates, clinical sites, team and investigator meetings.Support regulatory audits and inspections.Plan and manage program budgets & deliver per commitment.Contribute to the development and achievement of KPIs including clinical research budgets, clinical research targets, stakeholder satisfaction and clinical research impact.Maintain up-to-date knowledge of published literature in relevant therapeutic areas including the key clinical operations issues. Remain current on competitive developments.Lead/represent Clinical Affairs team, processes, programs across Abbott and external venues in partnership with senior management.Mentor and coach the next level of leaders and oversee programs to develop and build clinical research leadership capacity.Foster a culture and environment of innovative clinical research excellence. EDUCATION AND EXPERIENCE YOU’LL BRINGPrior experience in management and monitoring of CRO and investigative sites.Experience managing projects and working with clinical professionals and cross-functional product development teams.Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay development regulations.Knowledge of clinical practices in industry.Highly organized and detail-oriented, with solid analytical skills.Ability to understand strategic goals and match to the business needs of the company.Ability to independently manage and provide significant tactical leadership and guidance.Demonstrate ability to manage multiple, complex projects.Excellent written and verbal communication skills and the ability to work with various levels of the Company.Excellent matrix leadership.Embody a culture of improvement and progress; promote knowledge sharing.Strategic thinking and analytical skills. Strong written and verbal communication skills.Superior organization skills with excellent attention to detail.Excellent computer skills and knowledge of Microsoft Office and the ability to learn appropriate software. Experience utilizing clinical systems.RequiredBachelor's degree in a life science field required8+ years' experience in clinical research, including 5+ years clinical study/project management experience; 3-5 years' experience in diagnostics is preferred.Preferred Master's degree preferred.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 assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully:  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.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.Job SummaryJob number: 31054212Date posted : 2023-06-30Profession: Research & DevelopmentEmployment type: Full time