Apply on Employer Site

Medix · 10 hours ago

Clinical Research Manager - 247098

United States

Full-time

Remote

Senior Level

$105K/yr - $120K/yr

5+ years exp

Medix is a company focused on clinical research, and they are seeking a Clinical Research Manager to oversee the operational, logistical, and regulatory aspects of clinical research activities. This role involves managing clinical trials to ensure compliance with regulations and collaboration with internal teams and external partners.

MedicalPharmaceuticalWholesale

Hiring Manager

Emma Housel

Responsibilities

Manage the operational and logistical execution of clinical research studies to ensure efficiency, regulatory compliance, and adherence to established budgets and timelines

Ensure all clinical research activities comply with GCP, FDA regulations, Federal Code of Regulations, and applicable state and local regulatory requirements

Coordinate internal and external resources, including industry sponsors and contract research organizations (CROs), to support trial selection, patient recruitment, and study execution

Establish and maintain productive relationships with physician investigators and research partners to support ongoing and future research initiatives

Collaborate with internal clinical and operational teams to integrate clinical research into clinical facilities and support onboarding of new practices interested in clinical trial participation

Support the maintenance and effective use of the Clinical Trials Management System (CTMS)

Assist field coordinators with sponsor interactions, including site initiation visits, monitoring visits, audits, and responses to sponsor requests for information

Develop and maintain professional relationships with industry sponsors, CROs, investigator physicians, and clinical and business operations teams

Promote a patient-focused research culture emphasizing patient safety, data integrity, and quality

Represent the organization at sponsor investigator meetings, national conferences, and clinical research sites

Partner with clinical research leadership and quality teams to ensure quality metrics are met and conduct internal GCP audits to maintain program compliance

Maintain current knowledge of clinical research standards, best practices, and regulatory requirements

Recruit, train, develop, and supervise clinical research department staff, and support training and onboarding of new investigator physicians

Ensure all staff and investigator physicians maintain appropriate licensure, credentials, and certifications

Manage employee performance, including evaluations, time approval, coaching, and disciplinary actions as necessary

Support organizational goals by promoting teamwork, accountability, and effective collaboration across departments

Qualification

Clinical research experienceGCP knowledgeFDA regulations knowledgePeople managementClinical Trials Management SystemsProject managementManage prioritiesLeadership skillsOrganizational skillsCommunication skillsRelationship-building