ABOUT CLSI

CLSI is the leading global non-profit laboratory medicine standards development organization, with over 24,000 professional members, 2000 active volunteers, and 250 standards products. CLSI standards are recognized by laboratories, accreditors, and government agencies worldwide as the best way to improve their testing outcomes, maintain accreditation, bring products to market faster, and navigate regulatory hurdles.

Are you looking for a new way to use your valuable clinical laboratory experience? CLSI is seeking a full-time standards development program manager. Responsibilities of this position include managing the development of consensus standards and related products according to established processes and procedures, providing technical support for project development, managing committee relations, and assisting in the development of effective marketing communications and education programs. The qualified applicant must possess a bachelor’s degree in medical technology or a related field, with two to five years of laboratory experience. Knowledge of global and national standards environments and the role of standards in health-related fields is a plus. Experience with method evaluation (validation and verification) is strongly preferred. In addition, prior experience managing committees or project teams is preferred.  Must have experience with Microsoft Office products. This is a remote position. See full job description below:

Position Purpose

This is a professional position that is accountable for managing all aspects of the standards development cycle for assigned CLSI committees. The Program Manager is accountable for building and maintaining relationships with internal and external stakeholders and overseeing tasks associated with the development of assigned consensus documents and other products, as well as identifying emerging needs in assigned technical areas. The incumbent is responsible for implementing recruitment, retention,  and recognition programs of volunteers in assigned areas and for collaborating with marketing for education and communication efforts regarding associated standards products. The incumbent is also responsible for participating in CLSI’s collaborative, and cooperative work environment, and for exhibiting CLSI’s values in all work performed.

ACCOUNTABLE FUNCTIONS

Standards Development Program Management 

· Manages the implementation of all aspects of assigned standards development activities 

· Builds and maintains relationships with volunteers and all stakeholders participating in the standards development process

· Ensures that all targets, timelines, budgets, and requirements are met

· Oversees and manages all activities associated with assigned expert panels and their respective subcommittees, document development committees, and/or working groups

· Manages consensus and other projects’ development within assigned committees according to established policies, processes, procedures, and priorities and in conformance with CLSI’s Standards Development Policies and Processes

· Ensures quality and timely completion of consensus standards, guidelines, and other products as well as due process throughout all phases of development,.

· As assigned, assures the development of ISO documents align with the ISO Directives, and may serve as Secretary of one or more Working Groups for ISO/TC212, Clinical laboratory testing and in vitro diagnostic test systems. 

Operational Effectiveness

· Helps achieve continual improvement in the quality and timeliness of consensus documents and derivative products developed and published by CLSI,.

· Ensures implementation of quality system principles in all steps of standards and product development

· Monitors the external environment to identify standards development trends, new technologies, and constituent needs for consensus documents for assigned committees

· Provides staff support to assigned committees to achieve objectives by preparing budgets, timelines, meeting materials, and following up on all action items discussed in meetings 

· Serves as a staff resource on technical and scientific information in assigned areas and provides product, technical, and relevant market information internally, as needed

· Responds to volunteer, member, and customer needs within assigned scope

· Implements programs for recruitment, retention, and recognition of volunteers

· Responds to volunteer, member, and customer needs within the organization’s scope of and process for standards development

· Addresses questions, concerns, and/or complaints throughout the project

· Provides relevant product and market information to Marketing for integration into effective marketing communications and education programs 

· Maintains current knowledge of legislation, standards, guidelines, and industry best practices

Performs other duties and responsibilities as assigned by the supervisor.

RESPONSIBLE AND SUPPORT FUNCTIONS

Fiscal Management/Budget Responsibilities/Use of Resources 

This position does not have direct revenue or expense responsibilities; however, the incumbent is responsible for efficient and effective use of CLSI resources.

Liaison Responsibilities 

· Consensus Council: a minimum of nine volunteers overseeing the standards development processes

· NetForum: Association management software

· Other vendors as required

Image/Brand Responsibilities 

· Responsible for ensuring an excellent and consistent member, volunteer, customer, and user experience in all assigned standard development activities 

· Responsible for adhering to CLSI values and for professionalism, excellence, ethics, and inclusiveness in all aspects of assigned work 

· Responsible for collaboration and teamwork with staff, volunteers, stakeholders, and other partners

People Management Responsibilities

· None

Responsible for leading for standards development and product development process activities for assigned committees to optimize how CLSI develops standards to drive greater impact and accomplish strategic and operational goals that advance the mission of CLSI  

Supports business development, marketing, membership, communications, global strategy and operations.

EXPECTED OUTCOMES 

The Program Manager works under regular direction and is expected to manage innovative and compliant approaches for standards development and product development processes. The incumbent is expected to work with assigned committees and manage the development of consensus documents and related products while maintaining a robust network of stakeholders and industry leaders to support the standards landscape. This role is expected to collaborate with other departments and identify opportunities for continuous improvement of CLSI quality and standards/product development processes. 

CLSI is a great place to work. Our benefits include: 

• Significant, thought-leading, and globally impactful work.
• Brilliant and curious teammates.
• Highly passionate and committed people.
• Flexible, fully remote workplace.
• Supportive scheduling and ample PTO.
• Competitive benefits.
• Best-in-class technology and applications.
• Commitment to global and personal health and wellness.

We are also an equal opportunity employer. We are a diverse team and are committed to creating an inclusive environment for all employees.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

Knowledge

• Working knowledge of scientific and technical standards environments 
• Working knowledge of the health care industry 
• Working knowledge of quality management systems (QMS) processes 

Skills and Abilities

· Considerable skill in written and oral communication in English, including expert level skill in sentence construction, grammatical conventions, etc.

· Expert level skill with Microsoft Office suite of products

· Skill in or ability to quickly learn Smartsheet technology.

·  

· Ability to lead and manage multiple activities, work independently, and meet deadlines in a fast-paced environment

· Highly organized, analytical, and process driven skills in achieving a high degree of accuracy with close attention to detail

· Skill in using sound and mature judgment and a positive attitude in collaborating with volunteers and colleagues 

· Skill in demonstrating integrity and the highest ethical standards

· Proven ability to learn quickly, take initiative, and be accountable for results

· Ability to work closely with a diverse team of individuals in a highly intense and fluid work environment

· Ability to travel nationally and internationally on an infrequent basis

 EDUCATION AND EXPERIENCE

· Bachelor’s degree in health or life sciences or a related field 

· A minimum of five (5) years of relevant work experience

· Clinical laboratory experience or healthcare service industry experience is a plus 

· An equivalent combination of education and experience may be substituted