Senior Biospecimen Project Manager

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

Please note: This is a remote role is open to candidates based in the United States. Candidates located in California are eligible only if they reside outside of the San Francisco Bay Area (defined as locations more than 100 miles from the Bay Area).

Responsibilities:

• Drive biospecimen lifecycle management from sample receipt to analysis and final disposition
• Ensure accurate specimen metadata
• Communicate study specimen updates to client groups and stakeholders
• Increase the efficiency of specimen management through sharing of knowledge and best practices
• Provide site support and drive query resolution
• Participate or lead special projects as assigned
• Adhere to client policies and Standard Operating Procedures
• Review clinical study protocols and service providers’ scope of work documents
  for sample handling and processing details
• Set up and maintain a complex study sample tracker – experience in manual sample tracking for complex clinical studies
• Create and manage project plans
• Manage data transfer plans with analytical laboratories
• Manage data received from external and internal laboratories, including data generated in exploratory studies
• Manage specimen metadata discrepancies and ensure resolution
• Submit specimens for analytical assays per study timelines
• Review status of specimens collected and completeness of data
• 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
• Provide guidance to others and act as technical resource within the department
• Lead projections for annual and long-term planning to clinical team
• Provide oversight and management to junior personnel

Skills/Abilities:

• Understanding of transaction-based inventory and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations
• LabMatrix experience preferred
• Strong excel experience required, extensive macro and template building knowledge desired
• Strong computer literacy, including Word, SharePoint, Smartsheet and PowerPointAdvanced planning, organizational, time management skills

Experience / Education:

• B.A./B.S. in life sciences, medical technology, or related field and 5-7 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 is 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 [email protected] or call +1 (423) 722-3155.