Job Description
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 Data Specialist is responsible for reconciliation of tasks of regulated data streams to clients. They participate in internal discussions and decisions related to the delivery of data services to stakeholders. They perform duties associated with day-to-day monitoring of data streams to ensure quality deliverables on time.
Essential Duties and Responsibilities
• Remediates omissions, inconsistencies and inaccuracies in client data streams.
• Reviews files to ensure information meets the data transfer specification.
• Conceives, suggests and contributes new and improved real-time validity checks in the LabConnect central laboratory information management system (CLIMS).
• Formulate systems and ensure projects meet strategic needs.
• Ensures the prospective data transmission complies with the data transfer specification document including file structure, format and layout.
• Ensures consistency of laboratory analyte reference ranges, decimal precision, units of measure and correlation factors where present.
• Communicates with internal team members to ensure the quality of the data sent to the client and remediates errors consistent with internal processes
• Communicates with study Data Managers to ensure queries are being resolved
• Maintains study scheduler in accordance with the contracted agreement and client communications.
• Creates, maintains, and revokes access to designated LabConnect delivery platform as directed by the study Data Manager
• Performs routine work within the scope and training as directed by the group manager.
Education and Experience
• High School diploma required. Associate’s degree or university program certificate preferred.
• Four to six years of laboratory or clinical trial industry experience preferred.
• An equivalent combination of above education and experience will be considered.
• Experience in clinical trial protocol development and FDA 21CRF11/GCP strongly preferred.
• Certification as an ASCP Medical Technologist or Medical Laboratory Technician is preferred.
Skills and Ability
• Strong computer skills required, including proficiency in Microsoft Office suite.
• Excellent attention to detail.
• Ability to adhere to established timelines, processes and procedures.
• Strong planning and problem-solving skills.
• Self-motivation and ability to work well independently, as well as use a collaborative team approach.
• Excellent organization and time management, communication, multitasking, interpersonal, and listening skills.
• Ability to adapt to changing environments and requirements.
• Excellent listening and verbal comprehension skills, including ability to translate clients’ needs to team members.
• Ability to make quick but well-thought-out decisions.
• Customer service/client relationship management skills.
Supervisory Responsibilities: None
Physical Demands:
While performing the duties of this job, the occupant is regularly required to:
• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.
Travel Requirements: Minimal
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.