Senior Clinical Research Business Process Improvement Manager In this exciting role as Senior Clinical Research Manager in the Surgical Operating Unit, you will be responsible for leading the Clinical Operations Operational Excellence sub-function.You will have primary responsibility to lead the Clinical Research and Medical Science (CRMS) standard operational processes, clinical governance, business process improvement initiatives, standard reporting and systems and other key centralized activities to support the multiple functional groups and programs within our integrated operating unit.You will be a key partner in supporting projects and clinical studies across the operating unit, as well as partnering with Clinical Compliance and Quality, enhancing the ability to execute projects with clinical excellence within budget and on schedule.This position will report directly to the Director, Clinical Operations.We are seeking a talented individual who will provide leadership and vision for the Surgical Operational Excellence sub-function.In this role, the Senior Clinical Research Manager will be in a position of influence across CRMS functions and sub-functions critical to the success of the Surgical Operating Unit.Many programs are global and will require an understanding of the worldwide landscape.Location:Preferred locations include Minneapolis, MN, Mansfield, MA, North Haven, CT, and Santa Clara, CA. A remote working arrangement within the U.S. may be consideredTravel up to 25% (domestic and may include international travel).Careers That Change LivesJoin a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.To learn more about Inclusion & Diversity at Medtronic Click HereA Day in the LifeManage a team of direct reposts. Responsibilities include project allocation, performance reviews and development plans.Establishes and executes a clinical governance process for the CRMS organizationOversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. Provides project management support and expertise to study or project teamsFacilitates methodical forecasting of study activation and enrollment plansMonitors the project from initiation through delivery. Reviews status of projects and budgets; manages schedules and prepares status reports. Leads or leverages cross functional teams to evaluate, develop, and manage projects for key business processes. Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. Reviews current forecasts on project milestones and budget and assists with tools to document an action plan. Facilitates project or portfolio reviews with senior leadership, including discussing the latest operational metrics that address the Clinical function's performance against key objectives. Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies.Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.Additional tasks as assignedPerforms independently and is accountable for the following tasks: Develop, maintain and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation. Train teams on adopted practices. Train and coach team members as well as new resources on project management methodologies/ best practices. Develop and maintain the overall communications strategy and plan specific to the needs of the Clinical Research Department and associated stakeholders. Seek and analyze information from all cross-functional sources to understand the project scope and what activities need to be accomplished (including who, how, duration and effort). Partner with the clinical study teams to identify risk in clinical study lifecycle (planning through closure) deliverables and guide study teams in developing and executing mitigation plans. Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity. Must Have: Minimum RequirementsBachelor's degree with 7 years of clinical research experience with 5+ years of managerial experienceORAn advanced degree with 5 years of clinical research experience with 5+ years of managerial experienceNice to HaveClinical trial management and Medtronic clinical research experience Medical device program/project management experiencePMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification Experience in Communication Plan development and execution, strategic planning, and risk and change management Expertise in MS Project/SmartSheet (or similar scheduling software), project management techniques and tools; and both theoretical and practical aspects of project management Advanced proficiency in MS Excel, PowerPoint, and Word Experience in resource and expectations management in a matrix organization Ability to drive to completion in adherence to aggressive project schedulesCompetencies:Leadership skills include strong communication, problem solving, quality focus, business integration acumen, and change management. Demonstrated ability to work effectively globally on cross-functional teams.Experience in a high-demand and fast-paced environment. Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills. Ability to communicate complex information in a clear, concise manner.Excels in working on cross-functional teams in a highly matrixed organization.About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)CompensationA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefitshere. This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6here. The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
