Biospecimen Project Manager - Scientific Operations

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.


Summary
The Biospecimen Project Manager within FSP Solutions will be the centralized point of contact to drive biospecimen lifecycle management of antibody, pharmacokinetic and biomarker specimens and resulting analytical data from nonclinical and clinical studies.

What you will do:
• 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 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, review timelines
• 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
• Act as main sample management POC – Problem Solve/Trouble-shooting
• Assist with Study Close Out
What we need from you:
• BA/BS in life sciences, medical technology, or related field, required
• 3 - 5 years of client facing biospecimen lifecycle management from collection to disposition, required
• 1 - 2 years of project management experience, required
• 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

Working Conditions/Physical Demands, Travel, etc
• 100% remote working environment, with the ability to travel up to 2-4 times per year to CA for client site visits
• Ability to work standard core west coast business hours


Read more below and get ready for your next great employment adventure!


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 and AD&D
• We celebrate our differences, which enrich our Culture

We are a growing and global team which Values People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.


We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.


It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.


Equal Employment Opportunity Posters:

https://www.dol.gov/agencies/ofccp/posters


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