Manager, Project Design - Global Central Labs

Thermo Fisher ScientificHighland Heights, KY
Remote

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. This is a fully remote role supporting our Global Central Laboratories. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. The Role As a Manager, Project Design within Global Central Labs, you will lead and develop a team responsible for the study startup and database design activities that support global clinical trials. This role is focused on driving operational excellence across study setup, including oversight of Central Lab Specifications (CLS), database configuration and activation, site deliverables, workload prioritization, quality oversight, and escalation management. You will partner closely with Project Management, Operations, Scientific, Data Management, and client stakeholders to ensure studies are delivered with speed, consistency, compliance, and high-quality execution. In addition to leading day-to-day operations, you will play a key role in advancing organizational maturity by implementing process improvements, driving SOP and training compliance, managing quality events and CAPAs, and supporting scalable delivery across a growing and evolving central lab environment.

Requirements

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
  • 1+ year of leadership responsibility
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Experience within a Central Lab, Bioanalytical Lab, or other regulated clinical/laboratory services environment strongly preferred
  • Familiarity with study startup workflows, database configuration, or laboratory operations preferred
  • Experience working with LIMS/QMS platforms and applying AI or automation-driven solutions to improve operational efficiency, workflow optimization, or quality processes is strongly preferred.
  • Strong verbal, written and presentation skills
  • Solid Microsoft Office skills for analysis and presentation of data
  • Critical thinking skills to support quality decision making
  • Advanced knowledge of project management theories, principles and best practices relating to lab operations
  • Strong attention for detail orientation and compliance with procedures and policies
  • Effective client relationship management skills
  • Strong supervisory and management skills with ability to work effectively at all levels
  • Proficient in problem solving and prioritizing
  • Strong analytical and quantitative skills
  • Ability to multi-task and handle pressure

Responsibilities

  • Direct line management for teams, including performance management and development
  • Lead interviewing, selection, and onboarding activities
  • Own goal setting, mid-year and end-of-year reviews, and employee counseling
  • Lead focused coaching initiatives or PIPs where required
  • Oversee Project Design study assignment and queues to ensure timely, prioritized delivery
  • Own oversight of departmental quality events and CAPA implementation
  • Lead deployment of procedural changes and ensure SOP/training compliance
  • Manage internal and external escalations
  • Review and approve time records, expenses, leave, and overtime
  • Serve as back-up for Associate Director Study Design as required

Benefits

  • Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
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