[Remote] Biospecimen Project Manager

Note: The job is a remote job and is open to candidates in USA. LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations to accelerate the development of new medicines. The Biospecimen Project Manager will be the centralized point of contact developing and establishing processes to drive biospecimen lifecycle management in support of Translational Sciences and Clinical Trials teams.ResponsibilitiesDevelop and lead processes that support specimen lifecycle management from sample receipt to analysis and final disposition or long-term storageMonitor specimens with attention to tracking location, viability, alignment with retention requirementsEvaluate, develop and effectively document and communicate processEnsure accurate specimen metadataCommunicate study specimen updates to client groups and stakeholdersIncrease the efficiency of specimen management through sharing of knowledge and best practicesEstablish processes and systems to simplify transfer processes between vendors, ensuring accuracy in data recorded at study or project initiation and mechanisms to track specimen status and location throughout the duration of its lifecycleProvide site support and drive query resolutionManage specimen metadata discrepancies and ensure resolutionManage data transfer plans with analytical laboratories and resultant dataParticipate in or independently lead special projects as assignedAdhere to client policies and Standard Operating ProceduresReview clinical study protocols and service providers’ scope of work documents for sample handling and processing detailsSet up and maintain a complex study sample tracker, dashboards and tracking toolsAttend meetings or calls with Translational Sciences or Clinical Trial Management teams, vendors, partners and study stakeholdersCreate and manage project plans, templates and framework for consistent execution across vendors and projectsEstablish a centralized repository in a preferred vendor management system for MSAs, work orders, sample forms, validation or qualification results, and internal registry of assays or biomarkers for future useSupport study setup through the creation and implementation of intake forms consistently leveraged across vendors and sites supporting studiesReview and provide oversight of sample storage and retention policies, establishing framework for consistent tracking across projects and vendorsReview status of specimens received and completeness of dataEnsure that specimens are submitted and resulted for analytical assays per required timelinesInvestigate and resolve complex queriesEnsure transfer is complete; create reports for data management as neededSupport annual and long-term planning by monitoring and providing projections for milestones, specimen storage or analytical needs, and budgetManagement of archival study documentationSkillsB.A./B.S. in life sciences, medical technology, or related field and a minimum of 2-3 years of directly related experienceExperience in biospecimen lifecycle management required, with experience in life sciences or medically related fields such as clinical development or clinical laboratory analysisStrong Project Management experience, with demonstrated organizational skills requiredVery high attention to detail and excellent multi-tasking skills are required for success in this positionDemonstrated ability to establish and qualify processes, assessing risk and identifying mitigation strategies or creating streamline efficiencies where possibleUnderstanding of transaction-based inventory and data management systems as well as clinical trial processesUnderstanding of ICH, GCP, GLP, and local regulations requiredAbility to draft SOPs, work instructions, templates requiredExcel experience, macro and template building knowledgeExperience within sample tracking platforms, LIMS systems, SharePoint requiredAbility to lead projects within a cross-functional matrixVendor Management (bioanalytical and specialty laboratories) with outsourcing experience preferredBudgeting and forecasting experience preferredExperience with Clinical Maestro preferredBenefitsFinancial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)Health Benefits beginning on date of hirePTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your communityShort and Long-Term Disability, Life Insurance, and AD&DCompany OverviewLabConnect provides global central laboratory services It was founded in 2002, and is headquartered in Durham, North Carolina, USA, with a workforce of 501-1000 employees. Its website is https://www.labconnect.com/.Company H1B SponsorshipLabConnect has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.