Clinical Trial Manager

We are NOT accepting resumes from recruitment agencies or search firms.About Us:Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. We self-fund our projects through preclinical development and work with financial partners for clinical development and commercialization. Our portfolio of hydrogel technology positions us to be the leader in creating new hydrogel based medical devices to address unmet medical needs in a range of surgical interventions. We have launched over ten medical device companies based on this unique technology. These companies have generated over $4B in value and have helped over 5 million patients worldwide achieve better outcomes.Position Summary:This is a contract position (initial 8-month term with potential extension).The Contract Clinical Trial Manager (CTM) will serve as the sponsor-side operational study lead, responsible for day-to-day execution and oversight of clinical trial activities during study start-up, activation, and enrollment phases of the clinical trial. This role will act as an operational interface with CRO partners and internal cross-functional teams, ensuring timelines, budgets, quality standards, and compliance obligations are met.The CTM will manage study governance processes including risk management, decision logs, meeting cadence, and financial tracking, while supporting TMF oversight and clinical quality system activities.The CTM will report to the Senior Clinical Operations leadership and work closely with the CRO, Monitoring Manager, CRAs, Legal/Finance, QA, and external vendors.Job Responsibilities:Study Execution & Project ManagementLead day-to-day operational management of assigned clinical study(s) under the direction of the Sr. Clinical Operations ManagerDevelop and maintain detailed study timelines and project trackersCoordinate cross-functional study team meetings and maintain action item logsMaintain and actively manage the study risk log with mitigation plans and decision log; escalate significant risks appropriatelyTrack study milestones to ensure adherence to approved timelinesSupport development and execution of operational plans while ensuring compliance with current regulatory guidance and GCPsContribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, trial reports, and annual reportsServe as operational liaison with CROMonitor CRO performance metrics and escalate concerns to the Sr. Clinical Operations ManagerBudget & Financial OversightTrack study budget, accruals, and financial forecastsSupport invoice review and reconciliationCoordinate CTA/CTA Amendments in partnership with legal and finance as neededEnsure financial alignment between scope, contracts, and study executionMonitoring & Site IntegrationReview monitoring reports as needed, identify trends, and escalate issues appropriatelyConduct site level training as neededQuality & ComplianceEnsure study activities are conducted in compliance with applicable regulations, GCP, and company SOPsPerform sponsor-level TMF oversight reviews (in collaboration with CRO)Provide support in the development of new clinical processes and SOPs as neededSupport inspection readiness efforts through documentation tracking and quality reviewEnsure essential documents are filed appropriately and timelyUpload sponsor quality documents into the Quality Management System (QMS)Prepare routine study status updates and dashboards for internal stakeholdersSupport preparation of clinical study reports, clinical evaluation reports, and regulatory submission documentation as requestedQualifications & Requirements:Bachelor's degree in life sciences or equivalent training/experienceMinimum of 7+ years of clinical research experience within medical device industry, biotechnology, or pharmaceutical industryAt least 3-5 years of clinical trial management or study coordination experienceExperience working within a sponsor/CRO hybrid operating model preferredExperience supporting clinical study budgets, accrual forecasting, and vendor oversight requiredMedical device clinical trial experience strongly preferredDemonstrated knowledge of FDA regulations, ISO/ICH-GCP, and applicable clinical research standardsStrong understanding of clinical trial lifecycle from study start-up through close-outExperience maintaining risk registers, action logs, and project timelinesFamiliarity with clinical trial budgeting, accrual tracking, and invoice reconciliationAbility to analyze operational metrics and identify trendsStrong organizational and documentation skillsExcellent written and verbal communication skillsProficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with EDC/TMF systemsAbility to manage multiple priorities in a fast paced, small company environmentDemonstrated ability to work independently while escalating appropriatelyWorking Conditions:Long periods of time sitting or standing at a computerThe ability to travel to study sites, investigator meetings, and in person meetings as needed

Created: 2026-04-15