LabConnect

Role Description 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 - 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. Qualifications - 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. - Occasional meetings later in the day may be necessary to accommodate west coast hours. Benefits - 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.

Role Description The Quality Specialist, Sr. is responsible for assisting Quality Leadership with ensuring compliance, optimizing quality processes, and implementing strategic enhancements of the Quality Management System (QMS) in support of clinical trial operational activities. The Quality Specialist, Sr. will serve as administrator for the quality management software (QMS) and is responsible for development, configuration, and management of the QMS. Please note: this is a fully remote role, with candidates required to be based on the east coast. Responsibilities - Supervise and assist in management of QMS Quality Event reporting and related investigation, root cause analysis, proposed corrective and/or preventive measures, and timely closure. - Leads and project manages QMS activities, ensuring robust implementation and continuous improvement of document control, change control, non-conformance reporting, and supplier qualification/requalification processes within the QMS framework. - Communicates with internal team and clients on quality related matters. - Serves as team lead on QMS-related systems, ensuring compliance with regulatory standards. - Responsible for QMS metrics and reporting to leaders across the company. - Trains QMS users on workflow and associated tasks for modules within the QMS. - Leads configuration, optimization, and continuous improvement initiatives for electronic QMS (eQMS), ensuring alignment with organizational quality objectives and regulatory requirements. - Identifies and drives QMS-centric Lean and process efficiency initiatives, leveraging data analytics and stakeholder input to enhance system performance and user experience. - Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses. - Provide expert-level QMS compliance guidance and strategic quality assurance consultation to internal teams and external partners, ensuring adherence to industry best practices and regulatory expectations. - Schedules and conducts monthly quality review meetings as required. - Prepare training materials and conduct training for QMS topics. - Collaborates with Human Resources regarding training program requirements affected by the QMS. - Serves as Quality subject matter expert for configurable systems validation projects. - Conducts research and compiles reports. - Performs other tasks as defined by the Quality Assurance Leadership. Qualifications - 4-year degree preferred with 5-7 years of Quality Assurance Experience; or a 2-year degree with 8-10 years related experience and/or training; or equivalent combination of education and experience. - Must possess strong organizational and interpersonal skills. - Experience with QMS platforms such as Veeva is highly preferred. - Proven track record of leading QMS implementations or enhancements is a strong asset. Requirements - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. - Ability to write reports, business correspondence, and procedure manuals. - Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public. - Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. - Ability to apply concepts of basic algebra, statistics, and geometry. - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. - Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. - To perform this job successfully, an individual must have working knowledge of Microsoft Office applications, including word processing software, spreadsheet software, MS PowerPoint, and MS Project. - Advanced proficiency in QMS platforms (e.g., Veeva), including configuration, reporting, and user training and experience with eLMS also preferred. Benefits - 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.

Role Description The QC Specialist is responsible for the review of low complexity study setup and study setup amendment documents to ensure accuracy and completeness of information. They will review Operational Specification Documents (OSD) and any ancillary study documents and liaise with other departments as needed to ensure that the study is set up correctly. This is a remote role. Essential Duties and Responsibilities - QC of laboratory specification documents for accuracy of data or information presented including Operational Specification Document (OSD), Testing Schedules, Blood Volume Charts, Exclusion/Alerts/Blinding programming, Kit components (kit builds, requisitions and labels), and Laboratory Manuals. - Verify documents completeness and consistency within a document and between related documents, including but not limited to study protocols, budgets, kit components, requisitions, and labels, and internal scope of work documents. - Verify documents are completed on most recent template versions. - Cross departmental collaboration to ensure QC reviews are consistent with current process and quality standards. - Work closely with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment and PRM teams to resolve problems or quality findings identified during QC review. - Oversee and facilitate QC timelines with PRI, Project Amendment and PRM to ensure milestones are met. - Capture detailed documentation of noted QC findings for each document reviewed. - Capture, maintain, and analyze findings for trend analysis, metrics, and opportunities for enhanced training and process improvements. - Work performed must be in accordance with ICH Guidelines for Good Clinical Practice. - Assure that all QC findings and deviations are shared clearly and in a timely manner with the applicable study manager or team to be corrected or addressed in a manner consistent with good practices and company SOPs. - Organize, maintain, and archive electronic and hard-copy quality records in accordance with document control and record retention requirements; ensure accurate filing, traceability, and accessibility of controlled documents. - Support the electronic Quality Management System (eQMS) by assisting with the creation, review, issuance, revision, and change control of quality documents. - Utilize eQMS to log, monitor, trend, and report quality-related actions, Quality Events, client complaints, audit findings, and CAPAs to ensure timely closure and visibility. - Maintain quality logs, metrics, and dashboards to support management review, audits, and continuous improvement initiatives, ensuring compliance with internal procedures and regulatory expectations. - Work as a liaison between support groups as applicable. - As needed, interface with laboratory(ies), BD, Operations, and Data Management to communicate study needs or for problem solving. - Effectively and respectfully communicate with Project Managers to resolve any discrepancies or address any open questions or concerns. - Provide back-up assistance for other departmental functions, when needed. - Train incoming employees in all departmental processes. - Perform other related duties and tasks as necessary or as assigned. Qualifications - Required - Associate’s degree (A.A.A., A.S, A.A.S), or 4 years’ customer clinical research industry experience, 4 years set-up-related experience and/or Clinical Trials Materials or clinical specimen collection kit build experience. - Experience in contract research and/or research setting preferred. Skills and Ability - Excellent attention to detail, strong planning, and problem-solving skills. - Excellent organizational and time management skills. - Excellent listening and verbal comprehension skills. - Must be able to multitask throughout the workday, driving completion of work towards deadlines. - Ability to make well-thought-out decisions and adapt to changing environments and requirements. - Self-motivation and ability to work well independently as well as using a collaborative team approach. - Ability to adhere to established timelines, processes, and procedures. - Proficient in Microsoft Word, Excel, and database software. Physical Demands - Prolonged periods of sitting at a desk and working on a computer. - Prolonged use of computer and headphones for conference calls. - Communicate effectively via phone, video, and email. - Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. - Use hands and fingers to operate a computer and other office equipment. - Walk and/or reach with hands and arms. - Read text of various sizes. - Lift, pull and/or push up to 25 pounds. Travel Requirements - Minimal Benefits - 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

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 supports the implementation and communication outsourcing processes and practices. Responsible for providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays in the areas of flow cytometry, genomics/genetics and/or immunogenicity. Please note: this is a fully remote role, best suited for candidates located in the Pacific Time Zone or able to work Pacific Time hours, and will require travel at least twice per year to the client site, as well as occasional travel to vendor laboratories as needed. 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 one or more of the following areas: flow cytometry, genomics/genetics and/or immunogenicity. - 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 applicable guidelines & regulations Tech Transfer - Implements transfer strategy and coordinates between the product team and technical experts. - Responsible for establishing production phase monitoring requirements (PT and trending) - Technical monitoring of assay performance and evaluation of transfer pass/fail criteria. - Strong technical understanding in one or more of the following areas: flow cytometry, genomics/genetics and immunogenicity - Ensures vendor adherence to project plan. Supplier Management - 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. Department Support - Assist with writing SOPs for new laboratories - Assist with developing and implementing training documents and plans. - Assist with process improvement initiatives Education and Experience - B.S. in Life Sciences or related field. - Minimum of 5 years of industry-relevant project, laboratory, and management experience. 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.