Clinical Study Planning & Scheduling Lead

Overview

Leads study planning and portfolio scheduling across the Austin, Las Vegas, and Prague Clinical Research Units (CRUs), with a primary focus on early-phase clinical studies, and serves as the central owner of the integrated site study calendars.

What you'll do

• Own and maintain the integrated study calendars across supported CRUs, coordinating study placement for awarded and prospective studies and ensuring placement, key milestones, and scheduling changes are accurately and timely reflected.
• Evaluate prospective and awarded studies requiring CRU scheduling or placement assessment, partnering with the Feasibility Lead and relevant functional stakeholders to develop scheduling plans based on protocol requirements, participant and cohort needs, bed capacity, recruitment capability, procedural workload, specialized equipment and processing limitations, holidays, sponsor timelines, and competing site activity.
• Serve as the owner and coordination point for study-calendar changes, evaluating downstream impacts across the portfolio, implementing routine adjustments within established parameters, and developing scheduling alternatives or escalating significant capacity and prioritization decisions to Site Leadership.
• Facilitate cross-functional study placement and scheduling discussions with Site Leadership, Site Investigators, Participant Recruitment, Business Development, and operational stakeholders to identify constraints, challenge assumptions, and develop executable scheduling solutions.
• Coordinate portfolio scheduling across CRUs, including multisite studies, balancing confirmed and prospective study demand, site-specific capabilities, operational constraints, and available capacity.
• Maintain accurate scheduling data, trackers, and planning tools and provide schedule information to Finance and Site Leadership to support capacity planning, revenue forecasting, business decision-making, and continuous improvement of scheduling processes.
• Coordinate administrative activities supporting the Human Safety Committee (HSC), including managing submissions, scheduling reviews, preparing agendas and meeting materials, facilitating meetings, documenting minutes and decisions, and tracking follow-up activities in accordance with applicable procedures.
• Coordinate the CRU study placement process, ensuring required scheduling and operational inputs are available for review, facilitating placement discussions, documenting decisions and action items, and ensuring approved placements and scheduling changes are reflected in the applicable CRU calendars.
• Participate in client discussions as needed to communicate scheduling considerations, site capacity constraints, and potential scheduling alternatives.

What you'll need

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• Knowledge of the clinical trial process, with an emphasis on early-phase clinical research and CRU operations.
• Ability to review and interpret study protocols and identify requirements relevant to study scheduling and placement.
• Strong written and verbal communication and interpersonal skills.
• Excellent presentation and meeting facilitation skills.
• Excellent organizational skills and attention to detail.
• Strong time management, prioritization, and ability to manage multiple concurrent activities.
• Demonstrated business maturity, professionalism.
• Ability to work independently as well as in a collaborative team environment.
• Ability to work in an upright and/or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required; occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand, and to listen to and understand information presented through spoken words and sentences.
• Frequently interacts with others to obtain or relay information to diverse groups.
• Ability to perform a wide range of variable tasks as dictated by variable demands and changing conditions, with little predictability as to occurrence.
• Ability to perform under stress and to multi-task.
• Regular and consistent attendance.

Details

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms, and exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.