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.

Summary:

The Scientific Project Manager will leverage their expertise in bioanalytical methods, particularly in PK/ADA and Nab assays, to lead method development and validation initiatives. They will provide comprehensive oversight of bioanalytical projects, managing all aspects, including technical transfer, validation protocols, analytical testing, method trending, troubleshooting, and data review for a biopharmaceutical client. This role also involves supporting cross-functional teams through training and management summaries while ensuring effective collaboration and performance monitoring of CROs and service providers.

Essential Duties and Responsibilities:

Study Monitoring

• Coordinate outsourcing activities with analytical method performance oversight and timeline management of clinical studies involving large molecule bioanalytical assays in the following areas: PK/ADA and Nab.
• Serve as the initial point of contact between external vendors and internal stakeholders for outsourcing issue resolution, vendor capacity & capability management.
• Provide technical support to troubleshoot specific issues that impact the project.
• Ensure contracted studies are conducted in compliance with the respective protocol and GxP regulations and guidelines
• Lead PK/ADA/Nab status update meetings
• Track and maintain critical reagents inventory for the duration of studies

• Implements transfer strategy and coordinates between the product team and technical experts.

• Arrange Kickoff meetings and create development/validation, sample analysis timeline
• Responsible for establishing production phase monitoring requirements (PT and trending)
• Technical monitoring of assay performance and evaluation of transfer pass/fail criteria.
• Serve as SME for PK/ADA/Nab outsourced method to troubleshoot and provide technical expertise
• Ensures vendor adherence to project plan
• Review protocols and reports
• Assist Clinical Operations team with study start upand coordinate sample analysis
• Collaborate with Biospecimen Project Manager(s) in sample selection for disposition/long term storage

• RFP and review scientific content
• Review and approve invoices
• Lead operational point of contact between vendor and client
• Manage supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.

• Assist with writing SOPs for new laboratories
• Assist with developing and implementing training documents and plans.
• Assist with process improvement initiatives

Education/Experience/Skills Required:

• B.S., Life Sciences or related field
• 5 years of industry-relevant project, laboratory and management experience
• Project management expertise is highly desirable
• Strong planning, organizational, prioritization time management skills
• Understanding of inventory management and data management systems as well as clinical trial processes
• Understanding of ICH, GCP, GLP, and local regulations

• 100% remote with possibility of travel approximately twice a year to the client site
• Ability to work daily core business hours of 10am - 4pm Pacific Time, with the other hours flexible based on location

Read more below and get ready for your next great employment adventure!

Some of the Perks our LabConnectors Love:

• Financial Security (base pay, 401k match and annual bonus eligibility)
• Health Benefits beginning on date of hire
• PTO plan plus 10 Paid Company Holidays and 1 day to Volunteer in your community
• Short and Long-Term Disability, Life and AD&D
• We celebrate our differences, which enrich our Culture

We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.

We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.

It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.

Equal Employment Opportunity Posters:

https://www.dol.gov/agencies/ofccp/posters

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email talent@labconnect.com or call +1(423)722-3155.

For more information, visit www.labconnect.com

Other details

• Pay Type Salary