Biospecimen Project Manager

LabConnect; Johnson City, Northern (TN, KY); Hybrid; USD 90,000 - 115,000; Full time

Benefits offered by this job

Health benefits

Paid time off (PTO)

13 holidays per year

Disability insurance

Life insurance

Company-wide diversity & inclusion

Job summary

LabConnect seeks a Biospecimen Project Manager to drive lifecycle management of biospecimens from receipt through analysis and final disposition. You will transfer analytical data to the clinical repository and coordinate with analytical labs to ensure data integrity and timely reporting.

The role requires experience with LIMS systems, strong regulatory knowledge (ICH/GCP/GLP), and project-management skills, with attention to detail critical for success.

Qualifications

• Understanding of transaction-based inventory and data management systems in clinical settings.
• Understanding of ICH, GCP, GLP, and local regulations.
• Proficient in Excel, macro and template building knowledge.
• Experience with StarLIMS or other LIMS for biospecimen management.

Responsibilities

• Drive biospecimen lifecycle management from receipt to analysis and final disposition.
• Transfer analytical data to clinical repository.
• Create and manage project plans and data transfer plans with analytical laboratories.
• Provide specimen updates and reports to study teams.
• Lead process improvement projects under manager guidance.

Skills

Inventory systems

Regulatory knowledge (ICH/GCP/GLP)

Excel/macros

LIMS experience

Attention to detail

Project management

Education

B.A./B.S. in life sciences

Tools

StarLIMS

Job description

Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America

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 Biospecimen Project Manager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies.

Responsibilities:

• Drive biospecimen lifecycle management from sample receipt to analysis and final disposition
• Transfer analytical data to clinical repository
• Increase the efficiency of specimen management through sharing of knowledge and best practices
• Participate in or lead special projects as assigned
• Adhere to client policies and Standard Operating Procedures
• Review nonclinical and clinical study protocols and service providers’ scope of work documents for sample handling and processing details
• Set up study and electronic protocol in LIMS
• Create and manage project plans
• Manage data transfer plans with analytical laboratories
• Manage specimen metadata discrepancies and ensure resolution
• Submit specimens for analytical assays per study timelines
• Provide specimen updates of received specimens and data to study teams
• Review status of specimens received and completeness of data in data system; create reports for study teams when requested
• Contribute to meeting database locks by ensuring all specimens have a final result and data transfer is complete; create reports for data management as needed
• Participate in and/or lead process improvement projects under direction of manager
• Support manager in providing projections for annual and long-term planning

Education/Experience:

• Understanding of transaction-based inventory and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations
• Proficient in Excel, macro and template building knowledge
• Experience with StarLIMS or other LIMS for biospecimen management
• B.A./B.S. in life sciences, medical technology, or related field and min 3-5 years of directly related experience.
• Experience in life sciences or medically related fields, including clinical development, biospecimen lifecycle management, or clinical laboratory analysis.
• Project Management experience is also preferred.
• Very high attention to detail and excellent multi-tasking skills are required for success in this position.

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 viewthe 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/

Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America