Scientific Project Manager

  The Scientific Project Manager (Bioanalytical Study Manager) will be responsible for providing project management oversight to a biopharmaceutical client tasked with managing and executing analytical testing, method development and/or validation of such assays as immunoassays, bioassays, pharmacokinetic and/or flow cytometry assays under GLP/GCP.  They will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Project Manager must have the ability to effectively monitor the performance of CROs and service providers. They will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.Essential Duties and Responsibilities   Vendor Management: Support the team 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. Study Coordination: 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. Documentation and Data:  Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). Drive the delivery of data transfer specifications and ensure data accuracy. Sample Logistics: Track and reconcile sample testing, resolving any issues that arise. Contribute to cleaning and finalizing data. Education and Experience Bachelor’s, or Master’s level equivalent degree in Life Sciences or related field, required Scientific Project Manager Requirement: 2 - 3 years' experience in the drug development and/or clinical trial processes Equivalent amount of experience managing projects, including timelines, budgeting and forecasting  Experience with method development, validation and troubleshooting 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  Working Hours, Location, Travel: For US Candidates. Standard East Coast Business Hours Some travel may be required