Prin Clinical Research Specialist

Medtronic
Posted

Post Expires

Type

Researcher / analyst

Careers That Change Lives The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.  A Day in the LifeThis position is responsible for leading clinical project activities related to one or more clinical studies. In a matrix management structure across assigned project resources (Clinical Operations, Safety, Biostats, Medical Writing, Data Management, and Clinical Quality) this position is responsible for managing the achievement of study milestones. The Clinical Study Manager role ensures studies are conducted to meet business objectives, stay on time, to budget and are completed with highest quality. Responsibilities will also include performing and/or overseeing the daily in-house operations associated with the studies. Independently handle various clinical study assignments. 

  • Responsible for study budget, timeline, resource, and risk mitigation ongoing review to ensure completion of the study according to forecast
  • Responsible for overseeing deliverables of monitoring, data management, biostatistics, and clinical research specialists through all study phases
  • Responsible for contracts and budget terms for the clinical study
  • Responsible for ensuring successful completion of clinical site audit activities (corporate and regulatory), including pre-inspection training at clinical sites
  • Responsible for timely completion of periodic clinical reports and modules for regulatory submissions including 510(k), PMA, IDE, and Design Dossiers
  • Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system (people, facilities, tools, and training)
  • Ensures the quality policy/system is planned, understood, implemented and maintained by ensuring compliance within the department
  • Responsible for the development, maintenance, and execution of Medtronic Standard Operating Procedures (SOPs) for clinical investigations and all other applicable regulatory
  • Responsible for the development of study plans, informed consent creation, case report forms, clinical site study material, and clinical databases
  • Coaches, reviews, and delegates work to Clinical Research Specialists
  • Contributes to defining the direction for processes, standards, or operational plans based on business strategy with a significant impact on work group results
  • May manage large projects or processes that span outside of study management
  • execution
  • review
  • Safety Monitoring Boards and other related clinical meetings
  • Advises direct reports and other staff members on meeting organizational goals,
  • adhering to schedules, and resolving technical or operational problems
  • Interface with study investigators and all external study research personnel
  • Provide study updates and risk mitigation strategy recommendations to senior
  • leadership team
  • product development, work stream teams, etc.)
  • Provide input in Clinical Manager’s forum concerning projects, operational decisions
  • Performs related duties as assigned

Must Have: Minimum Qualifications

  • Bachelors degree in science or healthcare
  • Minimum of 7 years of clinical research experience, or advanced degree with a minimum of 5 years experience

Nice to Have

  • Working knowledge of the Code of Federal Regulations 21 CFR, ISO 14155, Medical
  • Device Directive (EC), and Good Clinical Practices (GCP)
  • Proficient knowledge of medical terminology
  • Excellent written, oral, and interpersonal communication skills
  • Ability to work independently and effectively on cross-functional teams
  • Ability to comply with written procedures, instructions, SOPs and other documents
  • Results and solution oriented
  • priorities and competing demands
  • Medical device experience preferred

Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Day in the Life 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. 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. EEOIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees

 

More Information

Posted

Post Expires

Type

Researcher / analyst

Irvine%2C%20United%20States

Irvine , United States