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Research Manager/Study Director

Expired Job

Medtronic Inc. Coon Rapids , MN 55433

Posted 2 months ago

Careers that Change Lives:

Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.

The Research Manager will serve in a role with two primary responsibilities: a people manager (~30%) and a study director (~70%).

As a study director, the incumbent:

  • Manages preclinical animal research studies evaluating the safety and efficacy of medical products from Medtronic businesses.

  • Ensures compliance to all applicable regulations in the execution of these studies.

  • Applies scientific, clinical, and/or engineering expertise to facilitate success of these projects.

As a research manager, the incumbent:

  • Manages the study directors to provide daily guidance and performance management.

  • Contributes to evolving business systems and practices.

A Day in the Life:

Management

  • Provides technical and managerial leadership to a team of study directors and contract personnel

  • Defines roles and responsibilities for direct reports.

  • Provides coaching and direction to employees and ensures their proper training for completion of their assigned tasks.

  • Provides direction for resource management and input for AOP budgeting of capital purchases, expenses, resources, etc and other department needs.

  • Ensures completion of department objectives by meeting respective target goals.

  • Establishes business practices, processes and/or information systems of the department and the facility; aids in management of business relationship with sponsor management; manages the performance of study directors, including administering performance reviews, individual development plans, and planning resources.

  • Works collaboratively with study directors and PRL staff to ensure completion of all activities required.

Preclinical Study/Project Management

  • Manages all preclinical study activities within and outside of PRL. Ensures the availability of the proper devices and equipment to successfully conduct the study, to control test devices to insure integrity. Determines study schedules; and with input from the project team determines study objectives. Ensures all aspect of the data package meet protocol requirements and expected scientific practices.

  • Leads a multidisciplinary team in the development, conduct and completion of Preclinical studies. This team is made up; Quality Assurance, Surgical and Veterinary Support, Animal Care, Clinical Chemistry, Pathology, and Project Managers, Engineers and researchers.

  • Partners with other scientists, researchers and engineers in the development of study designs and protocols.

  • Independently manages studies of significant complexity (e.g. disease states, extensive data collection). Contributes to setting the overall preclinical strategy for collaborative sponsor groups.

  • Plays key leadership role in setting the overall preclinical strategy for collaborative sponsor groups.

  • Mentors study directors and study coordinators in completion of their assigned tasks.

Regulations

  • The study director serves as the single point of study control and is ultimately responsible for the compliance of the study to Good Laboratory Practices, the Animal Welfare Act, and all other applicable regulations.

  • Interfaces with quality assurance, regulatory committees (e.g. IACUC), and Regulatory Affairs regarding requirements and results of the study.

  • Reviews Preclinical study data intended for regulatory submissions for compliance to Good Laboratories Practices.

  • Establishes department and facility standards for regulatory compliance. Facilitates departmental best practices. Leads the development of PRL policies, and facility standards for regulatory compliance, and ensures adherence to them.

Core Expertise

  • Applies core scientific and/or clinical expertise that supports the product plans and research objectives of the businesses he or she supports.

  • Researches and develops appropriate animal models that will meet the needs of the studies and research goals. Proposes and develops surgical and disease state animal models. Applies scientific and/or clinical expertise to act as a primary expert on therapies and/or disease states within and/or outside PRL.

  • Contributes to Medtronic's body of scientific knowledge by patenting ideas, authoring/coauthoring and/or presenting scientifically unique findings to either a Medtronic audience or the medical and scientific community at-large.

  • Uses strong management skills to provide work direction and performance management for the study directors.

Business

  • Manages and meets department requirements for billing.

  • Assists in planning of budget and study/project schedule in meeting group business goals.

  • Assists in business operations and improvements.

  • Takes a leadership role in establishing business practices, processes and/or information systems of the department and the facility.

  • Leads continuous improvement initiatives.

  • Must be available to work variable hours and weekends to support business needs. Due to the nature of the work required by this position, weekend and evening coverage may be required.

  • Ability to travel up to 25%, including international travel, for training, classes, and other departmental business, as needed.

Good Laboratory Practice

Employees must conform to the SOP's and documentation that applies to their work areas. This includes proper documentation techniques, updating the SOP's, training on the SOP's and knowledge of the GLP regulations that apply to their area.

Environmental Health and Safety

Medtronic is committed to a safe, healthy and environmentally conscious workplace that is in compliance with all applicable laws and regulations. All employees are expected to develop a pro-active, cooperative attitude toward issues of health, safety and the environment. Participation in the PRL EHS program through EHS suggestions, work procedure EHS analysis at SOP reviews and EHS committee membership is the responsibility of every employee. In accordance with the Medtronic EHS Infrastructure and Responsibilities Policy, employees must:
1.Understand and follow EHS policies and procedures
2.Actively participate in EHS programs and training
3.Provide suggestions and to continuously improve EHS programs

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

  • Directs the activities of a scientific group in the research and/or development of an organization's products, projects, and programs.

  • Collaborates with others on the direction of basic research and development relevant to long-term objectives and concerns.

  • Writes and approves manuscripts for publication.

  • Develops strategies to ensure effective achievement of scientific objectives.

  • Monitors and evaluates completion of tasks and projects.

  • Oversees interdepartmental activities and research efforts.

  • Selects, develops, and evaluates personnel to ensure the efficient operation of the function.

Required:

  • Bachelor's degree (technical). Technical degree is defined as engineering, biological sciences or related medical/scientific field.

  • More than 5 years of experience directly supporting research or similar experience in a medical/scientific area.

  • Management experience

Nice to Have:

  • Masters degree will substitute for 2 year of experience. A Ph.D./D.V.M./MD will substitute for 3-5 years of experience.

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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.


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Research Manager/Study Director

Expired Job

Medtronic Inc.