Senior Clinical Research Specialist

Careers that Change Lives

The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Initiates, reviews and approves required study plans for study startup, maintains and takes actions for updates and/or replacements, and monitors site activation.
• Participates in overall clinical management plan, protocol and case report form development.
• Performs site initiation activities, follows-up and resolves site issues during study execution, conducts site management and study closure activities.
• Performs site file reviews.  Perform clinical study data review.  reviews data discrepancies, ensures data queries are being resolved, works closely with monitors to ensure monitoring action items are resolved, and generates reports.   Reports on observed trends and conducts site management.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance. Prepares study materials and/or training and tracks and maintains study documentation.  Sets up and maintains accurate clinical study files.
• Conducts quality review of study reports.
• Reviews sites’ invoices in accordance with the approved budget.
• Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives.
• 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.
• Reports on progress and results of clinical investigations for the assigned sites.
• Performs assessment of quality or key performance metrics.  Identifies risk and opportunity for improvement.  Implements necessary corrections and corrective actions.
• May be responsible for clinical supply operations, vendor selection and management.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.

Assists clinical management with other duties as requested.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• Experience with clinical study management from sponsor perspective.
• Experience with managing FDA class III medical device IDE study,
• Experience in managing multiple clinical research sites with proven results in study execution.
• Excellent and demonstrated organizational and interpersonal skills.
• Demonstrated clinical monitoring and/or data management experience is a plus.
• Prior experience in CTMS Clinical Trial Management System and Electronic Data Capture such as Oracle Clinical OCRDC or Medidata Rave preferred.

 

About Medtronic


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)