Location: Minneapolis, MN (OHQ) preferred; open for remote location.
Careers That Change Lives
Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.
The Sr. Clinical Research Specialist (Sr. CRS) is responsible for the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. With minimal supervision, the Sr. CRS will assume project management responsibilities for assigned studies and will be responsible and accountable for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements.
The Post Approval Clinical Surveillance team is recognized as an enterprise leader for cost effective global post market clinical surveillance methodologies and strategies to guide the generation of world class evidence and fulfill the Medtronic Mission. Current evidence needs have created increased need to report clinical data and the group is experiencing significant growth.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Oversees, designs, plans and develops clinical evaluation research studies. May be involved in early study development including statistical design of the trial.
- Prepares and authors protocols and case report forms.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
- Oversees clinical study operations, including safety, monitoring, data management, and site and vendor selection.
- Sets work direction for the study team including delegation and oversight of tasks.
- Escalates any study issues quickly to leadership, and ensures study milestones are met.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Drives local evidence dissemination & awareness.
- Responsible for the overall conduct and execution of a study (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans) to ensure all study deliverables are on track
- Initiates, coordinates and is responsible for developing study materials (e.g. protocol, informed consent, case report forms, training, etc.) in compliance with regulatory requirements, standard operating procedures (SOP), and alignment with study objectives
- Acts as the primary contact for site personnel to complete study initiation requirements and ensure protocol compliance, achievement of data quality metrics and deliverables, regulatory requirements, and good clinical practices
- Oversee activities and provides work direction for extended team members including (e.g. project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, SOPs, and appropriate regulations and guidelines
- Oversee follow-up and resolution of sites issues
- Assist in the preparation of budgets
- Prepare study reports, regulatory submissions, publications and/or presentations
- Proactively identifies and mitigates quality risk and/or issues associated with assigned studies/activities
- Conduct training of study site and/or Medtronic staff
- Participates in multidisciplinary taskforces to support continuous improvement initiatives
Must Have (Minimum Requirements):
- Bachelors degree required with a minimum of 4 years of clinical research experience, or advanced degree with a minimum of 2 years clinical research experience
Nice to Have (Preferred Qualifications):
- Degree in engineering, life sciences, or related medical/scientific field.
- Clinical Research experience at Medtronic or within a medical device industry.
- Experience working on a Global study team
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
- Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
- Experience in managing clinical trial data review.
- Ability to incorporate and adhere to good clinical practices and regulatory standards.
- Ability to manage multiple clinical research sites with proven results in study execution.
- Ability to identify and implement solutions in addressing study issues.
- Basic understanding of biostatistics and trial design.
- Proficient knowledge of medical terminology.
- Excellent project management and organization skills.
Together, 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)