Senior Clinical Research Business Process Improvement Manager

Senior Clinical Research Business Process Improvement Manager 

In this exciting role as Senior Clinical Research Manager in the Surgical Operating Unit, you will be responsible for leading the Clinical Operations Operational Excellence sub-function.  You will have primary responsibility to lead the Clinical Research and Medical Science (CRMS) standard operational processes, clinical governance, business process improvement initiatives, standard reporting and systems and other key centralized activities to support the multiple functional groups and programs within our integrated operating unit.  You will be a key partner in supporting projects and clinical studies across the operating unit, as well as partnering with Clinical Compliance and Quality, enhancing the ability to execute projects with clinical excellence within budget and on schedule.

This position will report directly to the Director, Clinical Operations.

We are seeking a talented individual who will provide leadership and vision for the Surgical Operational Excellence sub-function.  In this role, the Senior Clinical Research Manager will be in a position of influence across CRMS functions and sub-functions critical to the success of the Surgical Operating Unit.  Many programs are global and will require an understanding of the worldwide landscape. 

Location: Preferred locations include Minneapolis, MN, Mansfield, MA, North Haven, CT, and Santa Clara, CA. A remote working arrangement within the U.S. may be considered

Travel up to 25% (domestic and may include international travel).

Careers That Change Lives

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

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A Day in the Life 

• Manage a team of direct reposts. Responsibilities include project allocation, performance reviews and development plans.
• Establishes and executes a clinical governance process for the CRMS organization
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. 
• Provides project management support and expertise to study or project teams
• Facilitates methodical forecasting of study activation and enrollment plans
• Monitors the project from initiation through delivery. 
• Reviews status of projects and budgets; manages schedules and prepares status reports. 
• Leads or leverages cross functional teams to evaluate, develop, and manage projects for key business processes. 
• Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. 
• Reviews current forecasts on project milestones and budget and assists with tools to document an action plan. 
• Facilitates project or portfolio reviews with senior leadership, including discussing the latest operational metrics that address the Clinical function’s performance against key objectives. 
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. 
• 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.
• Additional tasks as assigned

Performs independently and is accountable for the following tasks:  

• Develop, maintain and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation. Train teams on adopted practices. Train and coach team members as well as new resources on project management methodologies/ best practices. 
• Develop and maintain the overall communications strategy and plan specific to the needs of the Clinical Research Department and associated stakeholders. 
• Seek and analyze information from all cross-functional sources to understand the project scope and what activities need to be accomplished (including who, how, duration and effort). 
• Partner with the clinical study teams to identify risk in clinical study lifecycle (planning through closure) deliverables and guide study teams in developing and executing mitigation plans. 
• Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.