Clinical Trials Program Manager (Full-Time)

Job Summary

The Clinical Trials Program Manager (CTPM) will own the entire clinical trial processes from study design to regulatory approval and will be provided all necessary tools for success. CTPM will be available on site to provide hands-on support and supervision of all Clinical Trials and Research staff and provide regular feedback and training/refresher training sessions. CTPM will also drive recruitment, enrollment, and retention of study participants in all Clinical Trials to ensure study success.

Essential Duties and Responsibilities

• Develop and execute winning strategies for recruitment, enrollment, and retention of study participants across all clinical trials to ensure successful completion of the clinical trials
• Lead scientific implementation and daily operation of research studies, monitoring protocol compliance and ensuring data quality and adherence to all relevant regulatory requirements
• Co-ordinate and manage all R&D activities, projects, and clinical trials to assure validity of findings
• Develop research protocols and associated procedures to achieve specific research aims
• Ensure adherence to protocols and oversee record management for research studies
• Source for grants and prepare grant applications and ongoing progress reports
• Aid with budget development and award preparation and submission for prime awards and subawards
• Develop tools for study implementation including data collection tools such as REDCap, standardized order sheets, study reference materials, and patient questionnaires. Evaluate these tools on an ongoing basis for validity
• Prepare and submit all study related updates, changes to research, required reports, and study related instruments to IRB, FDA, and other relevant regulatory authorities
• Maintain regular communication with IRB to ensure efficient review of study documents throughout life span of each protocol
• Create and maintain Key Performance Indicators for the Company and individual projects. Provide expert project management with multiple simultaneous projects
• Organize flow of study participants at study sites; ensure compliance with study visits and medications through frequent contact with study participants
• Extract medical data from charts requiring interpretation
• Perform quality assurance/quality control on data collected during study visits and review source documents. Develop and implement procedures for quality management
• Maintain regulatory files for the study in compliance with Sponsor/FDA/NIH/DoD/DSMB/IRB guidelines
• Perform regular statistical analyses on all study-related data using SPSS or other statistical software
• Lead study meetings and provides updates on protocol implementation status and make recommendations on operational issues
• Oversee and track budget expenditures for study operations
• Anticipate and prevent problems with sites or collaborators that may affect KPIs. Co-ordinate activities and information flow between collaborators, contractors, and other R&D stakeholders
• Aid with writing and editing NIH grants, scientific publications, research manuscripts, and IRB and IBC protocols for approval by medical school committees
• Prepare and present weekly & monthly project progress analysis and reports
• Prepare biannual project progress reports for NIH and other program/grant sponsors
• Perform other duties as assigned by management

Required Skills and Experience

• Bachelor’s degree in clinical field or health sciences. Post-graduate degree preferred
• Minimum 5-year experience in project management roles, preferably in clinical trials
• Advanced data management and analytics
• Excellent attention to detail
• Excellent leadership and interpersonal skills
• Excellent written and verbal communication skills
• Strong knowledge of healthcare, regulatory, and government funding opportunities
• Proven leadership experience with P&L responsibility
• Experience working with REDCap and VivaVault
• Must be able to interact effectively with study participants from diverse backgrounds
• Self-motivated, innovative, and competitive attitude to work
• Travel – up to 10% regional