Biospecimen Project Manager - Scientific Operations

LabConnect; Johnson City (TN); Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a Biospecimen Project Manager to oversee the lifecycle management of biospecimens in clinical studies. This role is pivotal in ensuring efficient specimen management and compliance with regulatory standards. The successful candidate will collaborate with pharmaceutical and biotech companies to enhance the development of new medicines. You'll be part of a dynamic team that values your contributions and fosters career growth in a supportive environment. If you're passionate about making a difference in healthcare and thrive in a remote setting, this opportunity is perfect for you.

Benefits

401k match

Annual bonus eligibility

Health Benefits

PTO plan

Paid Company Holidays

Short and Long-Term Disability

Life and AD&D Insurance

Volunteer day

Qualifications

• 3-5 years experience managing biospecimen samples required.
• Understanding of ICH, GCP, GLP, and local regulations needed.

Responsibilities

• Drive biospecimen lifecycle management from receipt to analysis.
• Communicate specimen updates to client groups and stakeholders.
• Manage data transfer plans with analytical laboratories.

Skills

Biospecimen lifecycle management

Attention to detail

Multi-tasking

Data management systems

Clinical trial processes

Education

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

Medical technology

Tools

Microsoft Excel

LIMS systems

Job description

Biospecimen Project Manager - Scientific Operations

Remote - US, 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.

Job Summary:
The Biospecimen Project Manager, part of our Functional Service Provider (FSP) Solutions division, will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies for one of our sponsors.

Responsibilities:

• Drive biospecimen lifecycle management from sample receipt to analysis and final disposition
• 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
• 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 received 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
• Support manager in providing projections for annual and long-term planning
• Provide support to others and act as technical resource within the department

Experience/Education/Skills Required:

• B.A./B.S. in life sciences, medical technology, or related field, required
• 3 - 5 years experience managing biospecimen samples from receipt to analysis and final disposition, required
• Understanding of transaction-based inventory and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations
• Very high attention to detail and excellent multi-tasking skills
• Proficient in all Microsoft products, including Excel, with macro and template building knowledge
• Experience with LIMS systems

Hours/Location:

• 100% remote, ability to work standard east coast business hours
• Potential travel 2 - 4 times per year in Cambridge, MA

Some of the Perks our LabConnectors Love:

• Financial Security (base pay, 401k match and annual bonus eligibility)
• Health Benefits beginning on date of hire
• PTO plan plus 10 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 on a mission to create healthier communities by accelerating the development of new medicines. 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.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email [e-mail] or call [phone].