Temp, Project Design Manager

Overview

Lab Connect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

The Temp, Project Design Manager is responsible for managing the setup and amendment of clinical trial projects. This role involves creating and amending operational documents, coordinating with internal teams, and ensuring client requirements are accurately translated into project deliverables. The Temp, Project Design Manager serves as a subject matter expert during internal and external discussions and contributes to process efficiency and quality standards.

Please note:

this is a temporary assignment, anticipated to last 12 months. The role is onsite in Johnson City, TN, with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m. EST.

• Initial Setups & Amendments
• Create or revise the Operational Specification Documents (OSDs) to define client requirements for studies of varying complexities.
• Create or revise customized test requisitions, laboratory manuals, and collection kit specifications.
• Serve as a project contact with Sponsors and Contract Research Organizations (CROs) to maintain communication channels and adherence to timelines.
• Attend internal and external calls as a Subject Matter Expert for Project Initiation and provide necessary information to Project Managers.
• Provide regular status updates to Project Management and Client Services leadership on setup progress.
• Translate client requirements into actionable steps for problem-solving and issue resolution, often requiring creative solutions while adhering to internal standards.
• Understand and interpret project-specific budgets.
• Cross-Functional Coordination
• Interface with internal functional departments to complete or assist with database setup and communicate study needs to meet client expectations.
• Liaise with colleagues to confirm completion of all setup-related tasks.
• Training & Mentorship
• Assist with project-specific training for internal staff.
• Mentor and train new team members to ensure consistent knowledge transfer and adherence to best practices.
• Create or oversee development of training materials, templates, job aids, and SOPs.
• Perform additional related tasks as assigned to support departmental and organizational goals.

• Bachelor's degree (B.A./B.S.) from four-year college or university with minimum of 3 years’ experience that is setup related experience and/or project management experience.
• Associates degree (A.S.) and 5-6 years central laboratory or related clinical experience, including at least 3 years’ experience that is setup related experience and/or project management experience.
• Must be experienced in customer service and possess excellent organization and interpersonal, communication and problem solving skills.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Clinical Research, Central Lab, and/or Project Management experience outside of Lab Connect will be considered.

• Excellent attention to detail, strong planning and problem-solving skills.
• Excellent organizational and time management skills.
• Excellent listening and verbal comprehension skills, including ability to translate client needs to team members.
• Ability to make well-thought-out decisions and adapt to changing environments and requirements.
• Self-motivating and ability to work well independently as well as using a collaborative team approach.
• Ability to…