Senior Study Start-Up Manager

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

Responsibilities

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• Travel (approximately 5%) domestic and/or international.

• Work closely with CS Management in reviewing incoming study awards and prioritize according to timelines and client requirements.*

• Assign studies to Set Up Team according to priority requests determined in conjunction with CS leadership.*

• Organize workflow and processes within the team and implement process improvements with CS Leadership.*

• Manage laboratory specification gathering process including ownership of setup software applications.

• Continuous develop laboratory setup software application including contributions to future improvements and management of KPIs

• Organize and implement training schedule for new Set up Specialists and Configuration & QC staff. Mentor and coach staff, so as to develop their on the job skills, encourage continuous learning and maximize growth potential*

• Assist in representing ICON on client calls and/or meetings in respect to the laboratory setup process

• Review and update SOPs, process flows and all training materials, with a view to quality improvements across all processes and workflows.*

• Work closely with the PM team in interpreting laboratory specification requirements and ensuring that all is clear and accurate enough for proper configuration into all systems, seeking guidance on any parameters that need clarification.*

• Provide PM with configuration support by entering selected elements of the study's specifications into ICL systems

• Create supporting documents for sites that facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables, study-specific Lab Manuals, and collection guides.

• When updates or additions are required for collection, packaging, shipping instructions or contact information to a study-specific Lab Manual or Requisitions, work with CS Leadership to determine whether or not those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly.

• Provide technical support and guidance to PM for all study configuration tasks*

• Assign study configuration and QC tasks to Configuration & QC specialists*

• Performs additional relevant responsibilities as requested by management.

Education and Experience Requirements

• Bachelor's Degree or local equivalent in science or technology field preferred.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• US/LATAM/CAN- Five years of experience with clinical trials, project management, and/or protocol set-up phase of studies

• Advanced knowledge of computer programs, excellent written communication and time management skills

• 3- 5 years' experience as a people manager

• Experienced multi-tasker with the ability to manage multiple projects

• Proven ability to train and mentor others on tasks and processes

• Knowledge of clinical trials industry, as well as an understanding of client and site needs

• Self-starter with track record of well-developed learning strategies

• Must be self-motivated and work well with various internal groups

• High level of organizational agility

• Proven ability to lead people and organize processes and workflow

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.


ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.