Biospecimen Project Manager

🕒 July 30

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

👻 Ghost score 55%

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• Develop and lead processes supporting specimen lifecycle management from sample receipt through analysis and final disposition or long-term storage • Monitor specimen location, viability, and retention alignment • Evaluate, develop, document, and communicate processes • Ensure accurate specimen metadata and resolve discrepancies • Communicate study specimen updates to client groups and stakeholders • Establish vendor transfer processes and track specimen status and location throughout its lifecycle • Provide site support and drive query resolution • Manage data transfer plans with analytical laboratories and resultant data • Participate in or independently lead special projects • Review clinical study protocols and service providers’ scope of work for sample handling and processing details • Set up and maintain complex study sample trackers, dashboards, and tracking tools • Attend meetings with Translational Sciences, Clinical Trial Management teams, vendors, partners, and study stakeholders • Create and manage project plans, templates, and frameworks for consistent execution • Establish a centralized repository for MSAs, work orders, sample forms, validation or qualification results, and assay or biomarker registries • Support study setup through intake forms used across vendors and sites • Oversee sample storage and retention policies and tracking across projects and vendors • Review specimen receipt status and data completeness • Ensure specimens are submitted and resulted for analytical assays within required timelines • Investigate and resolve complex queries • Ensure data transfers are complete and create reports for data management • Support planning by monitoring and projecting milestones, specimen storage or analytical needs, and budget • Manage archival study documentation • Adhere to client policies and Standard Operating Procedures

🎯 Requirements

• B.A./B.S. in life sciences, medical technology, or related field • Minimum of 2-3 years of directly related experience • Experience in biospecimen lifecycle management required • Experience in life sciences or medically related fields such as clinical development or clinical laboratory analysis • Strong project management experience, with demonstrated organizational skills • Very high attention to detail and excellent multi-tasking skills • Ability to establish and qualify processes, assess risk, identify mitigation strategies, and create streamlined efficiencies • Understanding of transaction-based inventory and data management systems and clinical trial processes • Understanding of ICH, GCP, GLP, and local regulations • Ability to draft SOPs, work instructions, and templates • Excel experience, macro and template building knowledge • Experience within sample tracking platforms, LIMS systems, and SharePoint • Strong planning, organizational, and time management skills • Ability to lead projects within a cross-functional matrix • Vendor management with bioanalytical and specialty laboratories and outsourcing experience preferred • Budgeting and forecasting experience preferred • Experience with Clinical Maestro preferred

🏖️ Benefits

• 6-month position, with potential for extension based on business needs and performance

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