R&D Manager, Clinical Research

Medline•Northfield, MN

1d•Hybrid

About The Position

This is a hybrid position that is based out of our corporate headquarters in Northfield, IL. Candidates must be local to the Chicagoland area or opened to relocation. Manage the Clinical Research function within corporate R&D, including personnel, project execution, and clinical evidence generation supporting Medline product development. This role oversees internal product evaluations, clinical studies, and customer-partnered quality improvement initiatives to ensure timely, compliant, and high-quality outcomes.

Requirements

Bachelor’s degree in a scientific or clinical discipline (e.g. Life Sciences, Nursing).
A least 4 years of experience in clinical research, clinical affairs, or R&D within the medical device or healthcare industry.
Experience in the indirect management of team members, including assisting in the development, training and assignment of work/projects to other members of a team.
Experience assessing and initiating actions independently.
Experience taking charge of a situation, team or project.
Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.

Nice To Haves

Experience supervising and leading cross-functional teams.
Experience controlling and coordinating concurrent projects, competing priorities, and critical deadlines.
Working knowledge of applicable regulations and standards, including: Good Clinical Practice (GCP) FDA clinical requirements (IDE, 21 CFR) or global equivalents ISO 14155 (clinical investigation of medical devices)
Familiarity with post-market clinical/real-world evidence activities

Responsibilities

Manage a team executing clinical research activities, including internal product evaluations, internal/external clinical studies, and customer quality improvement projects.
Plan and allocate resources to support clinical projects and evolving business priorities.
Collaborate with divisional personnel, quality, regulatory, commercial, and legal to define study strategies, timelines, and execution plans.
Oversee the design and execution of clinical studies and product evaluations to generate evidence in support of product development and post-market activities.
Partner with customers to drive quality improvement projects and leverage real-world data for product insights.
Identify issues and risks that might delay a project and make recommendations or develop contingency plans.
Ensure all team activities comply with applicable regulatory standards (e.g., GCP) and ensure internal governing procedures are maintained.
Monitor emerging clinical trends, technologies, and competitive products to inform innovation and strategy.
Day-to-day operations of a group of employees.
Budgetary responsibility for the team.
Interpret and execute policies for departments/projects.
Recommend and implement new policies or modifications to existing policies.
Provide general guidelines and parameters for staff functioning.
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.