Program Manager

Education
Masters required

PRINCIPAL DUTIES AND RESPONSIBILITIES :

Please note that the functions below are representative of major duties that are typically associated with this position. Specific responsibilities may vary based on study needs.

• Create and manage study deliverable timelines according to programmatic and sponsor-specified milestones.
• Work closely with the MPIs and the TOR investigative team to ensure all study activities are completed accurately and on schedule, and serve as the primary point of contact for operational and logistical coordination across sites.
• Oversee implementation of UG3 and UH3 phase milestones, including IRB submissions, site start-up activities, staff training and certification, run-in enrollment, and transition to the full efficacy trial per NCCIH requirements.
• Create systems for ensuring and maintaining compliance with applicable federal regulations, IRB requirements, and institutional policies and procedures.
• Conduct and/or supervise other research staff in preparing, submitting, amending, maintaining, and following study protocols.
• Create and or supervise systems for maintaining program information and study databases.
• Create and/or supervise systems for quality monitoring and assurance.
• Coordinate study activities and function as a resource for all study issues.
• Develop and manage program communication plans.
• Provide supervision in aspects of the data collection process, including email communications and electronic questionnaires.
• Maintain and collaborate with appropriate Research Management staff on updated Biosketches and Other Support documents of personnel.
• Draft and submit Progress Reports and Just-In-Time requests for funding agencies.
• Communicate with Research Management, relevant institutional offices (e.g., Supply Chain, Clinical Trials Office), the TOR Data Coordinating Center (DCC), and scientific collaborators across all study sites.
• Manage processing of institutional study agreements, data use agreements, and subcontracts in coordination with participating sites.
• Prepare budgets and budget components for research sponsors.
• Prepare materials for post-award processes, including revised budgets and progress reports.
• Manage personnel allocations, including updating, tracking, and ensuring proper reporting of study personnel effort.
• Track and monitor study charges and expenses to conduct study activities, including interface with relevant institutional offices (supply chain, research finance)
• Monitor participant enrollment and pay-per-participant billing across all sites; ensure accurate and timely submission of billing records in coordination with site PIs and institutional finance offices.
• Be responsible for the day-to-day activities of assigning work projects, monitoring the progress of all project staff, and directly supervising and evaluating the work of the Project Coordinator and Clinical Research Coordinators (CRCs), including serving as back-up when needed.
• Travel to sites (as needed but no more than 1 time per year).

Skills and attributes:

• Excellent organizational skills and ability to multi-task effectively
• Skilled in identifying opportunities to improve efficiency of research operations and subsequently execute improvements.
• Time management skills with the capability to prioritize among multiple requests from multiple individuals and the ability to change direction in response to a fluctuating work environment.
• Strong attention to detail and accuracy in managing timelines, budgets, and study milestones.
• Ability to monitor site performance and address site-specific issues proactively to ensure smooth operations.
• Ability to work successfully in a collaborative environment.
• Ability to manage diverse teams with different skillsets, work styles, and professional roles.
• Capable of training and mentoring team members in best practices for clinical trial operations and regulatory compliance.
• Experience in managing remote teams and ensuring consistent communication and accountability across sites.
• High personal work standards and sense of urgency about results - Ability to anticipate the needs of the group in a fast-paced environment.
• Problem-solving ability, including the ability to gather information, identify resources, and imagine alternatives.
• Skilled at assessing trial progression and identifying necessary adjustments to ensure project success.
• Demonstrates initiative and identifies key priorities, even in ambiguous situations with limited direction.
• Ability to work effectively under pressure and within short time constraints.
• Consistently demonstrates a positive, "can-do" attitude.
• Persistent focus on achieving or exceeding project goals, maintaining high productivity standards even in a challenging environment.
• Excellent written and verbal communication skills - Expertise in cross-functional communication
• Ability to clarify and distill complex issues to a variety of stakeholders with varying expertise.
• Cognizant and respectful of cultural differences in communication approach
• An ability to build strong relationships, read a room, and influence people at all levels.
• Intellectual curiosity and willingness to learn.
• Strong data management and analytical skills for tracking study performance, ensuring accuracy and compliance.
• Rigorous academic and/or professional background including clinical or research work.