Researcher / analyst
POSITION DESCRIPTIONThe Clinical Research Director is responsible for providing leadership in the strategy development and implementation of programs, policies/procedures and practices for the clinical research functions of Medtronic CardioVascular to ensure appropriate implementation of key business initiatives and to ensure clinical research programs meet customer, regulatory agency and payer requirements. POSITION RESPONSIBILITIES Develop and implement clinical research strategy and manage those systems and programs in order to meet business goals and objectives and to ensure clinical evaluations/studies are conducted in an appropriate manner. • Participate actively on leadership team activities and meetings. Provide input regarding strategic direction of the organization and tactical plans to achieve business objectives.• Prepare and manage annual operating budget, the strategic plan, and general department logistics and administration. • Manage clinical research functions to include clinical study management, data handling, and statistical analysis.• Assist Clinical staff with overall clinical management plans. Ensure that logistics of clinical studies such as study hypothesis creation, protocol development, investigator selection, investigator training, investigator reimbursement, and publication policies are clear and consistent with relevant Medtronic policies and the policies of relevant regulatory agencies.• Lead effort toward continuous improvement of the Clinical organization by focusing on core activities and core competencies and exploring the most efficient means of achieving Clinical organization goals. Strive to reduce cycle time and reduce expenditures related to clinical investigations.• Provide the primary technology linkage to other Clinical research entities and business units within Medtronic. Be aware of clinical research efforts within the corporation which might benefit CardioVascular and communicate to other business units activities within Cardiac Surgery which might benefit them.• Provide the primary clinical research interface with the cardiac surgery community and the technical community outside of Medtronic. Attend key cardiac surgery and scientific meetings as necessary to maintain strong clinical research contacts. Make presentations and / or publish articles which enhance the reputation of Medtronic.• Leverage the clinical activities of CardioVascular to build relationships with key customers with clinical research interests.• Actively participate on industry committees.• Assume leadership role for management of industry key opinion leaders (KOLs). This includes identification of KOLs, establishing contact with KOLs, nurturing relationships with KOLs and setting KOL strategies such that the influential leaders among cardiac surgeons are both users of spokespersons for Medtronic valve products. Careers that Change Lives
Responsibilities may include the following and other duties may be assigned.
- 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.
- People working within region/country may also have the responsibilities that include:
- Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local 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 of the Medtronic therapies across multiple businesses
Minimum RequirementsBachelors degree requiredMinimum of 10 years of Clinical Research experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of Clinical Research experience with 7+ years of managerial experience Nice to HaveMaster’s degree of PhD desireableJOB EXPERIENCE• 10 years clinical research experience in a medical device or related industry • Experience interacting with the FDA and other regulatory bodies through the full process of new product approvals• Experience at working with Class III (implantable) devices at all stages from concept through market released product• Seven + years in medical device industry. Seven + years in role of managing clinical studies of Class III (permanently implantable) devices• Previous experience conducting multiple post market approval / post market surveillance studiesSKILLS/COMPETENCIES• Demonstrated expertise in managing clinical studies and regulatory programs. • Proven project management and problem solving skills• Working knowledge of statistics, statistical methodology, and application of statistics in scientific / medical research• Demonstrated high proficiency in the following areas: Shaping strategy Building networks & relationships Attracting, developing & retaining top talent• Previous successful completion of multiple clinical studies including successful interaction with the FDA through product approval.• Eight plus years proven track record of building and leading high-performance teams.• Experience working with Cardiac Surgeons 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 Requirements The 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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