Senior Scientific Project Manager

Role Description

The (Senior) Scientific Project 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 Good Laboratory Practices (GLP). He/she will provide project management and technical support to teams conducting training, technical transfer, data review and trending analysis. The Sr. Project Manager must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.

What will you do?

• Vendor Management:
  • 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.
• 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.

Qualifications

• 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.

Working Hours, Location, Travel

• US-based, EST preferred (alignment with working hours).
• Fully remote position with potential for <5% travel.

Benefits

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility).
• Health Benefits beginning on date of hire.
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community.
• Short and Long-Term Disability, Life Insurance, and AD&D.