Clinical Research Manager

Lead Clinical Research ManagerMed X CROAbout Med X CROMed X CRO is a Toledo, Ohio–based clinical research organization specializing in neuroscience, with a focus on neurovascular and peripheral therapies. Operating as a lean, agile team capable of delivering studies across the U.S., Europe, and additional global regions, Med X partners with sponsors, investigational sites, and vendors to ensure rigorous, compliant, and efficient study conduct.Our value proposition is efficiency, specialization, and quality — offering rapid trial startup and enrollment supported by the precision of a dedicated neuroscience team. The work is dynamic and fast‑moving; our professionals simultaneously manage the needs of sponsors, sites, patients, regulatory bodies, statisticians, and vendors.Role OverviewThe Lead Clinical Research Manager oversees the operational execution of assigned clinical trials from startup through closeout. This is a hybrid role, and candidates must be based in the Toledo, Ohio area. This role serves as the primary operational lead between sponsors, investigational sites, vendors, and internal teams to ensure studies are conducted in accordance with appropriate regulations, and company SOPs. The Lead Clinical Research Manager drives timelines and deliverables, supports sponsor relationships, and ensures high‑quality study execution across all phases of the clinical trial lifecycle.Key ResponsibilitiesStudy ManagementManage day‑to‑day operational activities for assigned clinical trialsDevelop and maintain study timelines, trackers, and project plansEnsure compliance with protocol, GCP, FDA regulations, and internal SOPsIdentify operational risks and implement mitigation strategiesMonitor study progress, enrollment, and site performanceLead study team meetings and sponsor callsSupport database lock and study closeout activitiesOversee site management and monitoring activitiesReview monitoring reports, follow‑up letters, and escalation itemsSupport site startup activities including feasibility, regulatory collection, and site initiationEnsure timely resolution of data queries and protocol deviationsAssist with corrective and preventive action plansVendor & Sponsor ManagementServe as an operational point of contact for sponsorsCoordinate and oversee external vendors including IRBs, labs, imaging partners, EDC providers, DSMBs, and CECsTrack vendor deliverables and timelinesMaintain strong sponsor communication and provide routine study updatesQuality & ComplianceEnsure audit and inspection readiness throughout the study lifecycleOversee maintenance of TMF/eTMF documentationReview adverse events, serious adverse events, and protocol deviations for trends and compliance concernsMaintain quality standards and data integrity across all study activitiesFinancial & Operational SupportAssist with study budgets, forecasting, and resource planningReview and track site invoices and milestone paymentsSupport contract and change‑order discussionsMonitor study timelines and financial performanceLeadership & MentorshipProvide guidance and mentorship to CRAs, CTAs, and study coordinatorsSupport onboarding and training of new staffContribute to SOP, workflow, and process improvementsFoster a collaborative and positive team environmentRequired QualificationsBachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferredMinimum 5 years of clinical trial management experience within a CRO, pharmaceutical, or biotech environmentDemonstrated experience managing full‑cycle clinical trialsStrong knowledge of GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and ICH guidelinesExperience managing sponsor relationships and vendor oversightProficiency with eTMF systems, EDC platforms, and clinical project management toolsExcellent communication, leadership, and organizational skillsAbility to manage multiple studies and priorities in a fast‑moving environmentWork EnvironmentPrimarily remote role with occasional travel to investigational sites, sponsor offices, or company locationsFrequent use of computer systems, video conferencing, and digital collaboration toolsDomestic or international travel may be required for site visits, sponsor meetings, audits, or inspectionsFlexible hours may be needed to support teams across time zonesEqual Opportunity EmployerMed X CRO is an equal opportunity employer. We are committed to creating an inclusive workplace and providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, pregnancy, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.CompensationSalary Range: $75,000–$95,000 annually. The anticipated salary range for this position is $75,000 to $95,000 per year. Actual compensation will be determined based on job-related factors, including experience, qualifications, skills, education, geographic location, and business needs. This range does not include any additional benefits or other forms of compensation that may be offered.