Senior Scientific Project Manager

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Oversee project management for a biopharmaceutical client.

• Manage and implement analytical testing, method development, and/or validation of assays including immunoassays, bioassays, pharmacokinetic, and/or flow cytometry assays in accordance with Good Laboratory Practices (GLP).

• Provide project management and technical assistance to teams engaged in training, technical transfers, data review, and trending analysis.

• Supervise the performance of Contract Research Organizations (CROs) and service providers.

• Lead negotiations and contracts with third-party laboratory service providers for assay development and validation.

• Collaborate with business operations, procurement, and clinical teams to ensure the accuracy of Statements of Work (SOWs) and contracts.

• Manage critical reagent supply and sample analyses.

• Work closely with bioanalytical strategy leads, clinical trial teams, and laboratory service providers to finalize study documents and meet deadlines.

• Support the creation of innovative bioanalytical processes.

• Contribute to the preparation of clinical trial documents (e.g., electronic Case Report Forms (eCRFs), Informed Consent Forms (ICFs), SOWs).

• Facilitate the delivery of data transfer specifications and guarantee data integrity.

• Monitor and reconcile sample testing, addressing any issues that may occur.

• Assist in the cleaning and finalization of data.

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences or a related field is required.

• A minimum of 2 - 3 years of experience in drug development and/or clinical trial processes for a Scientific Project Manager is required.

• A minimum of 5 - 6 years of experience in drug development and/or clinical trial processes for a Senior Scientific Project Manager is required.

• Equivalent experience in managing projects, including timelines, budgeting, and forecasting.

• Experience in method development, validation, and troubleshooting is essential.

• Comprehensive knowledge and experience in bioanalysis within regulatory frameworks (GLP/GCP), including experience with pharmacokinetics (PK)/anti-drug antibodies (ADA) and/or biomarker analysis.

• Experience in Oncology is preferred.

• PMP certification and formal change management training are strongly preferred.

• High proficiency in MS Office Suite, including MS Project, Word, Excel, PowerPoint, Smartsheet, and SharePoint.

• Strong planning, attention to detail, communication, and organizational skills are necessary.

• Excellent verbal and written communication skills are required.

🏝️ Benefits

• Fully remote position with the potential for less than 5% travel.