Clinical Research Manager

Med 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 Overview The 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 Responsibilities Study Management Develop and maintain study timelines, trackers, and project plans Ensure compliance with protocol, GCP, FDA regulations, and internal SOPs Identify operational risks and implement mitigation strategies Monitor study progress, enrollment, and site performance Lead study team meetings and sponsor calls Support database lock and study closeout activities Oversee site management and monitoring activities Review monitoring reports, follow‑up letters, and escalation items Support site startup activities including feasibility, regulatory collection, and site initiation Ensure timely resolution of data queries and protocol deviations Assist with corrective and preventive action plans Serve as an operational point of contact for sponsors Coordinate and oversee external vendors including IRBs, labs, imaging partners, EDC providers, DSMBs, and CECs Track vendor deliverables and timelines Maintain strong sponsor communication and provide routine study updates Quality & Compliance Ensure audit and inspection readiness throughout the study lifecycle Oversee maintenance of TMF/eTMF documentation Review adverse events, serious adverse events, and protocol deviations for trends and compliance concerns Maintain quality standards and data integrity across all study activities Assist with study budgets, forecasting, and resource planning Review and track site invoices and milestone payments Support contract and change‑order discussions Monitor study timelines and financial performance Provide guidance and mentorship to CRAs, CTAs, and study coordinators Support onboarding and training of new staff Contribute to SOP, workflow, and process improvements Foster a collaborative and positive team environment Required Qualifications Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred Minimum 5 years of clinical trial management experience within a CRO, pharmaceutical, or biotech environment Demonstrated experience managing full‑cycle clinical trials Strong knowledge of GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and ICH guidelines Experience managing sponsor relationships and vendor oversight Proficiency with eTMF systems, EDC platforms, and clinical project management tools Excellent communication, leadership, and organizational skills Ability to manage multiple studies and priorities in a fast‑moving environment Primarily remote role with occasional travel to investigational sites, sponsor offices, or company locations Frequent use of computer systems, video conferencing, and digital collaboration tools Domestic or international travel may be required for site visits, sponsor meetings, audits, or inspections Flexible hours may be needed to support teams across time zones Equal Opportunity Employer Med 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. Compensation Salary 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. #J-18808-Ljbffr MedXCRO