Summary
The Senior Clinical Research Manager oversees the planning, execution, and management of clinical trials within the Center for Research Advancement (CRA), focusing on Pediatric studies currently in the divisions of Infectious Disease, Allergy and Immunology, Endocrine, Pediatric Hospital Medicine (PHM), Nephrology/Renal, Gastroenterology, and Pulmonary Medicine. This role ensures regulatory compliance, quality, and efficiency while managing study assignments, personnel effort, and financial resources. Key responsibilities include monitoring timelines and KPIs (feasibility, study activation, enrollment, safety, compliance, and study close-out processes), driving strategic coordination, and leading workforce management for our teams: including development, performance, and recruitment. As a member of the CRA leadership team, this position provides operational and strategic direction to advance research excellence.
Job Duties
- 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.
- Resource Allocation: Oversee assignment of study personnel across clinical research projects, ensuring appropriate expertise, balanced workloads, and adequate coverage to meet operational demands and timelines. Monitor staffing capacity, adjust assignments as priorities shift, and proactively address resourcing gaps through hiring, cross‑training, or workload redistribution.
- 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. Ensure study teams and sites are prepared for internal audits and study monitor visits.
- Risk Management: Proactively identify operational and compliance risks and implement mitigation strategies. Address complex site issues, protocol deviations, or compliance concerns, ensuring timely resolution.
- Study Documentation & Systems Management: Oversee data quality, query resolution, and interim data review meetings with cross‑functional teams. Ensure accurate and timely maintenance of essential regulatory documents. Lead the adoption, training, and optimization of clinical research technologies (CTMS).
- Investigator Support: Assist investigators and research staff with reporting requirements and site visits.
- Workforce Management: Lead and mentor clinical research and administrative staff; provide training and guidance on regulations, best practices, operational excellence, and career development.
- Training & Onboarding: Develop and implement training programs for new and existing staff; oversee onboarding.
- 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 based on company needs.
Minimum Qualifications
- Bachelor's degree.
- Five years of relevant experience.
Preferred Qualifications
- Bachelor’s degree in scientific, healthcare, or public-health–related fields or advanced degree in a healthcare or research-related field.
- Five years of clinical trial research experience.
- Two years of direct management experience.
- Experience in nursing or as a Research Nurse.
- Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC).
- Strong knowledge of federal, state, and institutional regulations governing clinical research.
- Excellent organizational, leadership, and project-management skills, with the ability to manage multiple projects and meet deadlines.
- Ability to work effectively in a fast-paced environment, overseeing all stages of complex clinical research studies, including feasibility, start-up, enrollment, and close-out.
- Demonstrated ability to multitask, prioritize competing demands, and maintain strong attention to detail.
- Exceptional verbal, written, and interpersonal communication skills.
- Proven ability to navigate, influence, and lead within a complex organizational environment.
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.