Lead Start Up Specialist, FSP

About the role

Drive rapid, accurate, and data-driven study start-up forecasts, benchmarking assumptions, scenarios, and planning. Develop creative processes, methodologies, data, and technologies to ensure ongoing delivery of valued Study Start-Up Services. Partner with Clinical Operations teams and TAU partners to improve overall study start-up metrics and implement processes.

Provide guidance, oversight, and mentoring to the FSP Site Start-Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study start-up, country and site selection, study start-up planning, and modeling. Create country-specific ICFs based on the Master ICF provided. Ensure standards are applied to the site start-up process across project portfolios and support continuous improvement activities while developing the process.

Guide the collection and analysis of all data to influence study start-up timelines. Leverage leading industry tools and data sources to provide data on start-up timelines and performance (data quality, start-up cycle time) to assist project teams with study initiation timeline forecasting. Agree to deliverables on a site-level basis with the internal team and monitor adherence to these. Promptly recognize and improve potential delays, and escalate non-performance.

Lead the internal FSP site start-up team, using the appropriate team members to help implement the Start-Up Project Plan. Drive delivery of all client and CRO-supported sites that are "Ready To Enroll" to the Start-Up Project Plan. Resolve escalated issues identified by the site start-up team in partnership with the Study Manager.

Responsibilities

• Develop and implement data-driven study start-up forecasts, benchmarking, and planning.
• Create and refine processes, methodologies, and technologies for Study Start-Up Services.
• Partner with Clinical Operations and TAU teams to improve study start-up metrics.
• Provide mentorship and oversight to the FSP Site Start-Up team.
• Develop data and methodologies for protocol study start-up, country/site selection, and planning.
• Create country-specific ICFs based on the Master ICF.
• Ensure consistent application of standards across project portfolios.
• Analyze data to influence study start-up timelines and performance.
• Leverage industry tools to provide insights on start-up timelines and cycle time.
• Monitor adherence to site-level deliverables and escalate non-performance.
• Lead the internal FSP site start-up team to implement the Start-Up Project Plan.
• Drive delivery of sites to "Ready To Enroll" status.
• Resolve escalated issues in partnership with the Study Manager.

Requirements

• BS degree or international equivalent in a life science.
• 4+ years of experience in Clinical Operations, Project Management, study start-up, and trial optimization with increasing responsibility within a pharmaceutical company, CRO, or relevant industry vendor.
• At least 2 years of direct responsibility in site activation and managing study start-up processes of clinical research studies at a sponsor or CRO.
• Experience with country-level ICF creation and requirements.
• Proficiency with software models and database structures.
• Global SSU experience preferred.
• Ability to explain data and facilitate data-driven decision-making.
• Expertise in principles driving country/site start-up and study start-up strategies.

Work Environment

The role operates in a fast-paced environment where:

• No deviations from the study protocol are allowed, and timelines must be strictly adhered to.
• Priorities change constantly, requiring on-the-spot adaptation.
• Teamwork and strong interpersonal skills are essential for smooth study execution.
• Data is collected directly into an electronic environment, requiring comfort with technology.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of the upper body and neck.
• Ability to access and use a variety of computer software, both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moving) objects, including luggage and a laptop computer, with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Pay

Target pay range: $85,000–$92,000 USD (remote).