Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
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
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
- 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!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe 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
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email [email protected] or call +1 (423) 722-3155.