Scientific Project Manager
The Scientific Project Manager (Bioanalytical Study Manager) will be responsible for providing project management reputed company 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 reputed company.
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 reputed company 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 reputed company regulatory environments (GLP/ GCP) to include experience with PK, reputed company 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, reputed company and PowerPoint, reputed company 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
Join reputed company and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love
- Financial reputed company (reputed company 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!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We reputed company in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
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If you need assistance to complete your job application, search for a job opening, or submit an online application at reputed company, please email talent@reputed company.com or call +1 (423) 722-3155.
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