Clinical Trial Start-Up Lead

GI Alliance; Austin (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

GI Alliance is seeking a study start-up manager to oversee end-to-end clinical trial start-up activities across the research network, from feasibility to SIV and site activation. You will coordinate business development, feasibility, finance, regulatory, and site operations to keep studies progressing on schedule.

You will maintain visibility into the start-up pipeline, address barriers, and drive cross-functional teams toward milestones while ensuring regulatory and site readiness and effective

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

Responsibilities

• Owns the end-to-end clinical trial start-up process across the research network from feasibility through SIV and site activation.
• 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.

Skills

Project management

Cross-functional coordination

Regulatory compliance

IRB knowledge

Education

Bachelor’s degree

Tools

CTMS

RealTime

CRIO

Job description

GI Alliance is seeking a study start-up manager to oversee end-to-end clinical trial start-up activities across the research network, from feasibility to SIV and site activation. You will coordinate business development, feasibility, finance, regulatory, and site operations to keep studies progressing on schedule.

You will maintain visibility into the start-up pipeline, address barriers, and drive cross-functional teams toward milestones while ensuring regulatory and site readiness and effective