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: LabConnect has an immediate opening within FSP Solutions for a Scientific Project Coordinator. This person will be responsible for providing operational oversight and support for outsourced analytical testing in ADA and PK bioanalysis. Support will include monitoring timelines, managing documentation and contracts, maintaining tracking logs, working with external vendor partners, facilitating communications, and participating in all aspects of a study life cycle from initiation to closure. Responsibilities: • Manage analytical method support documentation including dosing documents, reagent qualifications, reagent expiry extensions, and bioanalytical reports. • Manage study timelines and monitor scheduling and conduct of bioanalytical testing to ensure alignment with data transfer deliverable requirements. • Assist with monitoring outsourced bioanalytical method performance and identifying analytical trends. • Communicate project updates and issues to cross functional teams including scientific project managers, internal scientists, CRO staff and operational teams. • Manage and lead recurring cross-functional meeting series. • Assist in facilitating contracts with external suppliers. • Support shipping and reagent requests. • Maintain trackers related to issues and program-specific information. • Support sample disposition requests. • Contribute to the maintenance of external collaboration sites. • Manage logistics for new clinical study initiation. • Participate in and/or lead operational process improvements. Education, Required Knowledge and Skills: • B.S., Life Sciences or related field. Master's Degree and/or 2 year degrees may be considered with different levels of work experience • 4 years of industry- relevant project and/or laboratory management experience, required • 1 - 3 years of Large Molecule PK/ADA/NAb Bioanalytical bench experience preferred (validation experience in the laboratory is a plus) • Demonstrated project and timeline management skills • Proactive mindset/self starter • Solid organizational skills with attention to detail and ability to develop and follow process • Strong oral and written communication skills with experience in both strong team collaboration and technical writing • Experience working with vendors/service providers • Understanding of clinical trial processes • Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA) • Strong computer literacy, including word processing, SharePoint, presentation, and spreadsheet applications • Ability to work effectively in a cross-functional team matrix environment Work Hours/Travel: • 100% remote with the ability to travel to the client site up to approximately 1 - 2 times per year, on the west coast • Occassional meetings later in the day may be necessary to accommodate west coast hours
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 talent@labconnect.com or call +1 (423) 722-3155.
