Clinical Research Supervisor

• 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.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

DIFFERENTIATING FACTORS Autonomy: Supervises team members providing tactical and / or technical supervision.
Spends a portion of time performing individual tasks.
Receives assignments in task-oriented terms and delivers results according to established procedures. Organizational Impact: Plans operational objectives for a team of support personnel, typically within (1) department.
Decisions impact team schedules or the allocation of time or material resources.
Typically does not have budget or P&L accountability, but may manage day-to-day elements of the budget (eg, overtime for staff). Innovation and Complexity: Makes adjustments or recommends enhancements in systems and day-to-day department processes.
Problems and issues faced are generally defined, and may require understanding of broader sets of issues. Communication and Influence:

Communicates with internal and external customers and vendors.
Shares and exchanges relevant information to reach solutions.
Typically presenting information and exchanging information . Leadership and Talent Management: Supervises a team consisting of employees in the Support career stream only, such as production, technician, or clerical individual contributors A first level supervisor.
Provides day-to-day work direction for team, focused on maintaining steady workflow, resource allocation and productivity .
Provides primary input to hiring, firing, promotion, performance and rewards decisions for direct reports. Required Knowledge and Experience: Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.
Requires broad job knowledge of technical or operational practices within assigned discipline.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 1 year relevant experience.