Clinical Research Program Mgr

Careers that Change LivesIn this exciting role as theClinical Research Program Manager(CRPM) in theSurgical Robotics Operating Unit,you will be responsible for creating and executing business strategy and influencing internal and external customers to drive business results. This position requires innovative thinking and experience with respect to program strategy and project management for multiple clinical programs, evaluating the safety and effectiveness of new products and / or modifications to existing products. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and has significant impact to the business. Many programs are global and will require an understanding of the worldwide landscape.The CRPM will provide global leadership in the development, coordination, and execution of clinical research activities for multiple clinical programs and external research programs. The position may be responsible for all project management activities including the successful execution of clinical milestones in compliance with applicable clinical/regulatory standards, facilitation of effective inter-and intra- departmental relationships, evaluation of new processes and methods, and achievement of multiple Clinical Affairs departmental corporate goals and objectives on time and on budget.We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.To learn more about Inclusion & Diversity at MedtronicClick HereSurgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes. Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.We're making that exciting future possible — and disrupting one of the biggest and fastest growing markets in healthcare — with a game-changing portfolio of robotic and data & analytics technologies, services, and solutions.A Day in the Life·Develops and implements clinical evidence strategies to obtain timely product approvals form worldwide regulatory bodies.·May be assigned to support new product development representing the clinical function on the Core Team.·Provides leadership for the conduct of clinical studies and for the clinical 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 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.·Ensures clinical deliverables for regulatory submissions are accurately prepared and comply with regulatory approvals.·Represents the Medtronic Business Unit from clinical research respective within the country / region and also collects feedback from local internal and external customers and authorities.·Builds and maintains a strong network and close relationship with the various internal and external parties.·Leads execution for both local and global studies, manages clinical research projects over all the Medtronic therapies across multiple geographies.·Oversees quality by maintaining compliance, reviewing device complaints, organizing audit preparation and training study teams, reviewing audit reports, and implementing corrective actions.·Oversees the clinical department SOP/DOP review and development, employee training, and associated requirements.·Supports ongoing evidence requirements for products released for commercial use globally.Other Responsibilities:·Autonomy: Manages one or more medium scale, established programs with generally defined program plans and delivery methodologies.·Is accountable for overall program process, performance, and customer satisfaction.·Organizational Impact: Participates in establishing program objectives, timelines, milestones, and budgets.·Develops new policies and procedures that affect program management.·Typically has budget accountability for one or more programs.·Program decisions are generally recommended to higher level management.·Innovation and Complexity: Problems and issues faced are difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.·Problems typically impact multiple workstreams, departments or specialties.·Enhances programs management processes to improve program.·Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team.·Influences across functions and businesses while balancing divergent objectives to gain cooperation of other parties on program objectives and execution plans.·Leadership and Talent Management: Leads, directs, and reviews the work of a team of managers, experienced professionals and/or vendors who exercise latitude and independence in their assignments.·Establishes daily tasks necessary for successful program execution.·Not directly responsible for hire or fire decisions and people management.·Represent Clinical Affairs on the Program Core Teams·Interface with regulatory agencies, as appropriate·Provide high quality clinical evidence through study teams·Latitude in decision-making and determining objectives and approaches to critical assignments·Provides clinical strategy for study design development and global evidence collection·Provides management input review and approval of the Clinical Investigational Plan (study protocol), Instructions For Use (IFU), Investigator's Brochure, Report of prior Investigations, Case Report Forms (CRFs), and other appropriate sections of the Investigational Device Exemption (IDE), Clinical Evaluation Reports (CER), Clinical Study Reports (CSRs), and annual reports in consultation with the cross-functional project team, investigators, data management, and biostatistics.·Oversee the evaluation of clinical data/information, writing, and revising of annual, interim, and final reports and clinical sections of Pre-Market Approval (PMA) and Design Dossier submissions.·Oversee quality by maintaining team compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions·Prepare for potential regulatory inspections in collaboration with the study team and other internal stakeholdersMust Have: Minimum RequirementsBachelors degree requiredMinimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experienceNice to Have•Master's degree in Life Science/Engineering/Public Health degree preferred•7+ years of experiencemanaging clinical operations and/or programswithin Medtronic or medical device industry•Project Management Professional (PMP),Certification as a Lean Six Sigma Black Belt; MP/RMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification.•Excellent understanding ofglobal clinical compliance•Significant experience withmulti-national global clinical trials and/or external research programs•Global regulatory product inspection and preparationexperience•Extensive therapeutic disease knowledge and experience in thesurgical interventionsarea•Experience with Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), EU MDR (2017/745), and ISO 13485 and 14155About 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)