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Baylor College of Medicine · 4 hours ago

Senior Manager, Clinical Research - Pediatrics - Center for Research Advancement Administration

Houston, TX

Full-time

Onsite

Senior Level

5+ years exp

Baylor College of Medicine is seeking a Senior Clinical Research Manager to oversee the planning, execution, and management of clinical trials within the Center for Research Advancement, focusing on Pediatric Neurology, Genetics, and Medical Device studies. This role involves ensuring regulatory compliance, quality, and efficiency while managing study assignments and personnel effort.

EducationHigher EducationPharmaceutical

No H1B

U.S. Citizen Only

Responsibilities

Monitor Study Progress: Track and evaluate the performance of clinical trials, ensuring quality of services, adherence to timelines, and compliance with applicable regulations

Project Oversight: Provide effective planning, coordination, and oversight of research projects from initiation through completion

Site Coordination: Schedule, coordinate, and participate in internal feasibility meetings, pre-site visits, and site initiation visits

Quality Assurance: Design, implement, and oversee clinical research quality assurance and quality control programs

Protocol Development: Develop, implement, and monitor research protocols, procedures, and processes to ensure consistency and compliance

Regulatory Compliance: Ensure adherence to institutional policies and regulatory standards governing clinical research

Investigator Support: Assist investigators and research staff with reporting requirements and site visits

Staff Supervision: Lead and mentor clinical research and administrative staff; provide training and guidance on regulations, best practices, and operational excellence

Training & Onboarding: Develop and implement training programs for new and existing staff; oversee onboarding processes to ensure team members are equipped with necessary knowledge and skills for success

Operational Improvement: Drive continuous improvement initiatives by developing, implementing, and maintaining Standard Operating Procedures (SOPs), workflows, and best practices to enhance efficiency and compliance across research operations

Other Duties: Perform additional job-related responsibilities as assigned

Qualification

Clinical trial managementRegulatory complianceQuality assuranceCCRP certificationProject oversightLeadership skillsInterpersonal communicationOrganizational skills