Senior Scientific Project Manager

🔥 17 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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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

• Provide project management oversight to a biopharmaceutical client • Manage and execute analytical testing, method development and/or validation of assays such as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under Good Laboratory Practices (GLP) • Provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis • Monitor the performance of CROs and service providers • Lead the contracting with third-party lab service providers for assay development and validation • Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts • Manage critical reagent supply and sample analysis • Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines • Support the development of novel Bioanalytical processes • Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs) • Drive the delivery of data transfer specifications and ensure data accuracy • Track and reconcile sample testing, resolving any issues that arise • Contribute to cleaning and finalizing data

🎯 Requirements

• Bachelor’s, or Master’s level equivalent degree in Life Sciences or related field, required • 2 - 3 years' experience in the drug development and/or clinical trial processes for Scientific Project Manager, required • 5 - 6 years’ experience in the drug development and/or clinical trial processes for Senior Scientific Project Manager, required • Equivalent amount of experience managing projects, including timelines, budgeting and forecasting • Experience with method development, validation and troubleshooting • Extensive knowledge and experience in bioanalysis within regulatory environments (GLP/ GCP) to include experience with PK/ADA and/or biomarker analysis • Experience working in Oncology is preferred • PMP certified and formal change management training strongly preferred • Highly proficient in MS Office Suite, including MS Project, Word, Excel and PowerPoint, Smartsheet and SharePoint • Strong planning, attention to detail, communication, and organizational skills • Excellent verbal and written communication skills

🏖️ Benefits

• Fully remote position with potential for <5% travel