Senior Clinical Scientist - Technical Affairs

Overview

LabConnect 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 Senior Clinical Scientist role on the LabConnect Scientific Affairs team provides scientific and technical expertise to support both customers and internal business units. Specializing in clinical testing, this position is responsible for the technical oversight of a global clinical testing standardization program.  Additional responsibilities include reviewing clinical protocols, developing analytical strategies, facilitating scientific exchanges, and performing comprehensive data reviews to ensure high-quality outcomes. 

Responsibilities:

• Serves as a SME in clinical testing, providing strategy guidance and technical oversite for a global standardized clinical chemistry and hematology program.
• Reviews clinical protocols to determine testing needs and develops the analytical strategy within a global laboratory network.
• Overseeing validation work for specialist assays, such as genomics, LCMS and/or PCR
• Participates in relevant scientific exchange with sponsors, laboratories and internal LabConnect personnel. 
• Performs data review with respect to clinical data, harmonization trending, reference ranges, abnormal flagging and critical value reporting.
• Partners with cross-functional teams within LabConnect to investigate client escalations or technical issues and provide acceptable solutions within expected timelines.
• Supports scientific requests that come from various departments in the company including but not limited to Client Services and Business Development Operations.

Education/Experience/Skills Required:

• Medical Lab Scientist (MLS) Certification with a Bachelor's degree in life sciences or related health field discipline, required.
• 3 - 5+ years of relevant clinical laboratory bench experience, with a total of 7 years of industry related experience in clinical trials/research and/or central labs.
• Experience with method performance verification, a good understanding of linearity, accuracy and precision. 
• Experience with the harmonization of labs 
• Analytical and problem-solving skills with ability to come to conclusions and make clear concise recommendations based on scientific and technical information.
• Working knowledge of laboratory instrumentation and IQ/OQ/PQ processes
• Experience with method comparisons, accuracy, precision evaluations
• Ability to exercise independent judgment in review of protocols, testing strategy, and clinical objectives.

• Ability to influence and provide strategic recommendations to clients and internal decision makers.
• Sense of urgency to meet deadlines with ability to independently manage multiple projects and initiatives concurrently.
• Familiarity with CLSI guidelines and the application of standards in a global central lab environment
• Collaborative with excellent communication skills working with internal and external partners.
• Strong organizational and time management skills
• Intermediate computer skills, including Excel.  

Working Location/Hours/Travel:

• 100% remote with the ability to work standard east coast business hours.
• Minimal travel as needed.