Senior Scientific Project Manager

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 (Senior) Scientific Project 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 Sr. 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. What will you do?

• Vendor Management:
• 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.
• 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.

What will you bring to the table?

• 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
• Senior Scientific Project Manager Requirement: 5 - 6 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
• Extensive 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 UK candidates:
• This position will be remote with the ability to visit the customer office as needed for meetings (Cambridge, UK)
• 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:

• We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always
• The opportunity to make a meaningful impact on a passionate and growing team
• Strong communication and collaboration within a smaller sized team
• Access to tools and resources that empower you to excel in your role

In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. We are proud to be an Equal 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. LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with the General Data Protection Regulation (GDPR). For this job posting, all hiring decisions are made with meaningful human involvement and consideration. In this context, no applicant is subject to a decision based solely on automated processing within the meaning of Article 22 of the 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. Apply tot his job Apply To this Job