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19 Labconnect Regulatory Affairs Manager Jobs Hiring Near You

LabConnect

Biospecimen Project Manager

Johnson City, TN · On-site +1

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and ... Understanding of ICH, GCP, GLP, and local regulations * Proficient in Excel, macro and template ...

labconnect

Project Manager

Represents LabConnect at client and/or investigator meetings. * Performs other related duties and ... regulatory materials; write clear reports and procedures; and effectively present information to ...

LabConnect

Biospecimen Project Manager

Johnson City, TN · On-site +1

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and ... Understanding of ICH, GCP, GLP, and local regulations * Proficient in Excel, macro and template ...

LabConnect

Medical Writer

Johnson City, TN · On-site +1

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and ... The Medical Writer is responsible for authoring clinical trial and regulatory documents, through ...

LabConnect

Quality Audit Specialist

Johnson City, TN · On-site +1

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and ... Quality Management in monitoring GCP regulatory compliance and quality in clinical trial ...

labconnect

Quality Audit Specialist

... Quality Management in monitoring GCP regulatory compliance and quality in clinical trial ... Schedule and organize internal and external assessments of LabConnect by QRS or Clients. * Schedule ...

LabConnect

Senior Quality Specialist

Johnson City, TN · On-site +1

$79K - $109K/yr

Assists management in assuring organizational readiness for regulatory inspections by scheduling ... LabConnect also prioritizes the privacy and security of your personal data. All candidate ...

labconnect

Biospecimen Project Manager

Understanding of ICH, GCP, GLP, and local regulations * Proficient in Excel, macro and template building knowledge * Strong planning, organizational, time management skills * Experience with StarLIMS ...

labconnect

Biospecimen Project Manager

Understanding of ICH, GCP, GLP, and local regulations * Proficient in Excel, macro and template building knowledge * Strong planning, organizational, time management skills * Experience with StarLIMS ...

labconnect

Biospecimen Project Manager

Job Summary The Biospecimen Project Manager will be the centralized point of contact developing and ... Understanding of ICH, GCP, GLP, and local regulations required * Ability to draft SOPs, work ...

labconnect

Senior Biospecimen Project Manager

Understanding of ICH, GCP, GLP, and local regulations * LabMatrix experience preferred * Strong ... Project Management experience is also preferred. * Very high attention to detail and excellent ...

labconnect

Medical Writer

The Medical Writer is responsible for authoring clinical trial and regulatory documents, through ... Strong time and project management skills. * Strong leadership experience in a team environment.

labconnect

Senior Quality Specialist

$84K - $116K/yr

Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses * Provide industry leading QMS ...

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Infographic showing various Regulatory Affairs Manager job openings at Labconnect in the United States as of August 2026, with employment types broken down into 97% Full Time, and 3% Contract. Highlights an 23% Physical, 3% Hybrid, and 74% Remote job distribution.

Biospecimen Project Manager

LabConnect

Johnson City, TN • On-site, Remote

Full-time

Medical, Life, Retirement, PTO

Re-posted 13 days ago

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
  • Ensure accurate specimen metadata
  • 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
  • Strong planning, organizational, time management skills
  • 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 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.

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