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. 

Job Summary

The Biospecimen Project Manager will be the centralized point of contact developing and establishing processes to drive biospecimen lifecycle management in support of Translational Sciences and Clinical Trials teams.

Please note: This is a 6-month position, with the potential for extension based on business needs and performance.

Essential Duties and Responsibilities

• Develop and lead processes that support specimen lifecycle management from sample receipt to analysis and final disposition or long-term storage
• Monitor specimens with attention to tracking location, viability, alignment with retention requirements
• Evaluate, develop and effectively document and communicate process
• 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
• Establish processes and systems to simplify transfer processes between vendors, ensuring accuracy in data recorded at study or project initiation and mechanisms to track specimen status and location throughout the duration of its lifecycle
• Provide site support and drive query resolution
• Manage specimen metadata discrepancies and ensure resolution
• Manage data transfer plans with analytical laboratories and resultant data
• Participate in or independently 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, dashboards and tracking tools
• Attend meetings or calls with Translational Sciences or Clinical Trial Management teams, vendors, partners and study stakeholders
• Create and manage project plans, templates and framework for consistent execution across vendors and projects
• Establish a centralized repository in a preferred vendor management system for MSAs, work orders, sample forms, validation or qualification results, and internal registry of assays or biomarkers for future use
• Support study setup through the creation and implementation of intake forms consistently leveraged across vendors and sites supporting studies
• Review and provide oversight of sample storage and retention policies, establishing framework for consistent tracking across projects and vendors
• Review status of specimens received and completeness of data
• Ensure that specimens are submitted and resulted for analytical assays per required timelines
• Investigate and resolve complex queries
• Ensure transfer is complete; create reports for data management as needed
• Support annual and long-term planning by monitoring and providing projections for milestones, specimen storage or analytical needs, and budget
• Management of archival study documentation

Education and Experience

• B.A./B.S. in life sciences, medical technology, or related field and a minimum of 2-3 years of directly related experience
• Experience in biospecimen lifecycle management required, with experience in life sciences or medically related fields such as clinical development or clinical laboratory analysis
• Strong Project Management experience, with demonstrated organizational skills required
• Vendor Management (bioanalytical and specialty laboratories) with outsourcing experience preferred
• Budgeting and forecasting experience preferred

Skills and Ability

• Very high attention to detail and excellent multi-tasking skills are required for success in this position
• Demonstrated ability to establish and qualify processes, assessing risk and identifying mitigation strategies or creating streamline efficiencies where possible
• Understanding of transaction-based inventory and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations required
• Ability to draft SOPs, work instructions, templates required
• Excel experience, macro and template building knowledge
• Experience within sample tracking platforms, LIMS systems, SharePoint required
• Experience with Clinical Maestro preferred
• Strong planning, organizational, time management skills
• Ability to lead projects within a cross-functional matrix

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.