Note: The job is a remote job and is open to candidates in USA. LabConnect improves lives by partnering with pharmaceutical and biotech companies to accelerate the development of new medicines. The Senior Scientific Project Manager will oversee project management for a biopharmaceutical client, managing analytical testing and method development while ensuring compliance with Good Laboratory Practices.
Responsibilities
- 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
Skills
- 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
- 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
- Experience working in Oncology
- PMP certified and formal change management training strongly preferred
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
- We celebrate our differences, which enriches our culture!
- Career growth opportunities, globally
Company Overview
Company H1B Sponsorship