Biospecimen Project Manager

🔥 44 minutes ago

🍂 Massachusetts, Tennessee – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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Logo of LabConnect

LabConnect

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

• Serve as the centralized point of contact for biospecimen lifecycle management and resulting analytical data from clinical studies • Drive biospecimen lifecycle management from sample receipt to analysis and final disposition • Ensure accurate specimen metadata • Communicate study specimen updates to client groups and stakeholders • Improve specimen management efficiency by sharing knowledge and best practices • Provide site support and drive query resolution • Participate in or lead special projects • 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 complex study sample trackers • Create and manage project plans • Manage data transfer plans with analytical laboratories • Manage data received from external and internal laboratories, including exploratory studies • Manage specimen metadata discrepancies and ensure resolution • Submit specimens for analytical assays according to study timelines • Review specimen receipt status and data completeness • Support database locks by ensuring all specimens have final results and data transfer is complete • Create reports for data management as needed • Support annual and long-term planning projections • Provide support and act as a technical resource within the department

🎯 Requirements

• 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 • Project Management experience strongly desired • Excellent communication skills • Strong planning, organizational, and time management skills • 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

🏖️ Benefits

• 100% remote work arrangement • Ability to work standard east coast business hours • Potential maximum travel 2–4 times per year in Cambridge, MA

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