Manager, Study Start Up (32539) in Austin, Texas at GI Alliance

Description

The study start-up manager is responsible for the end-to-end management and execution of clinical trial start-up activities across the research network, from feasibility through Site Initiation Visit (SIV). This role serves as the central owner and “conductor” of the start-up process, coordinating business development, feasibility, finance, regulatory, and site operations to ensure studies progress efficiently from opportunity identification to activation.

The study start-up manager maintains comprehensive visibility into the network’s start-up pipeline, proactively identifies barriers and delays, establishes priorities, and drives cross-functional teams toward established milestones. While functional teams retain responsibility for their respective deliverables, the study start-up manager is accountable for ensuring those activities remain coordinated, timely, and aligned with overall study activation goals.

This individual must be highly operational and willing to step into any portion of the start-up process when additional support is needed. The study start-up manager must understand and support feasibility assessment completions, source documentation creation, site capability evaluations, and other start-up activities, when necessary, to prevent delays.

Key Responsibilities:

• Owns the end-to-end clinical trial start-up process across the research network from feasibility through SIV and site activation, serving as the central point of accountability for study progression.

• Maintains oversight of the entire study start-up process, including timelines, milestones, dependencies, priorities, risks, and target activation dates.

• Serves as the primary cross-functional coordinator between business development, finance, regulatory, operations, recruitment, investigators and site leadership.

• Drives functional teams toward established start-up milestones, proactively identifies bottlenecks or stalled activities, facilitates resolution, and escalates barriers when necessary.

• Partners with business development and the Feasibility Specialist to ensure timely completion of feasibility assessments and appropriate transition of awarded studies into start-up.

• Provides hands-on support with feasibility, source document creation, site capability assessments, vendor management, and other start-up activities when additional support is necessary to maintain timelines.

• Coordinates and tracks contract/budget negotiation, regulatory and IRB submissions, vendor contracting, and any other activities to ensure workstreams progress concurrently and efficiently toward activation.

• Partners with operations to ensure site readiness, including investigator and staffing assignments, equipment and calibration, laboratory and pharmacy/IMP requirements, technology, supplies, space, and protocol-specific operational needs.

• Establishes and facilitates regular start-up communication/meetings, clearly identifying functional ownership, deadlines, outstanding items, risks, and upcoming milestones.

• Coordinates SIV readiness and scheduling with internal teams and sponsor/CRO partners and ensures critical requirements are completed prior to initiation.

• Conducts final readiness reviews, tracks post-SIV action items through completion, and facilitates an effective handoff from study start-up to Clinical operations following activation.

• Develops and monitors network-wide study start-up KPIs, including feasibility turnaround, award-to-activation timelines, contract/budget cycle times, regulatory timelines, and SIV readiness.

• Identifies recurring causes of start-up delays and leads continuous improvement efforts to standardize and accelerate start-up processes across the research network.

• Provides routine study start-up metric reporting to research leadership, ensuring clear visibility into study status, risks, expected activation dates, and overall performance.

Qualifications

Bachelor’s degree; equivalent clinical research experience may be considered.

• 5+ years of clinical research experience, preferably within a clinical research site, physician practice, or multi-site research network.

• Strong experience with all aspects of research execution, including feasibility, regulatory, budgets/contracts, source creation, site qualification, and SIV preparation.

• Demonstrated understanding of the complete clinical trial lifecycle and dependencies between business development, finance, regulatory, and clinical operations.

• Experience managing multiple studies, sites, and competing start-up priorities simultaneously.

• Strong knowledge of ICH-GCP, FDA regulations, IRB requirements, and clinical research site operations.

• Experience with CTMS and electronic regulatory systems such as RealTime, CRIO, or similar platforms preferred.

• Strong project management skills with demonstrated ability to establish timelines, manage dependencies, and drive cross-functional accountability.

• Highly organized, proactive, deadline-driven, and comfortable operating in a fast-paced environment.

• Demonstrated ability to identify barriers and independently drive issues toward resolution.

• Strong communication and relationship-management skills with the ability to work effectively with investigators, site teams, executives, sponsors, and CROs.

• Willingness and ability to work hands-on within the start-up process when additional support is required.