Biospecimen Project Manager

LabConnect•Johnson City, TN

About The Position

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 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.

Requirements

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
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

Nice To Haves

Vendor Management (bioanalytical and specialty laboratories) with outsourcing experience preferred
Budgeting and forecasting experience preferred
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
Experience with Clinical Maestro preferred
Strong planning, organizational, time management skills
Ability to lead projects within a cross-functional matrix

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