Lead Start Up Specialist, FSP

Our FSP team is currently seeking a Lead Study Start Up Specialist to join our growing team! Candidates must be within the United States or Canada. Summary: Drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate 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 startup metrics and implement processes. Provide guidance, oversight, and mentoring to theFSP Site Start Up team, delivering activities to support Clinical Programs, including data and methodologies for protocol study startup, country and site selection, study startup planning, and modeling.

Create country-specific ICFs based on the Master ICF provided. Ensure standards are applied to the site startup process across project portfolios and support continuous improvement activities while developing the process.. Guide the collection and analysis of all data to influence study startup timelines.

Leverage leading industry tools and data sources to provide data on startup timelines and performance (data quality, startup cycle time) to assist project teams with study initiation timeline forecasting. Agree to deliverables on a site-level basis with the internal teamand 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 ToEnroll" to the Start Up Project Plan. Resolve escalated issues identified by the site start up -team in partnership with the Study Manager

Qualifications

& Experience

Requirements

(Minimum Required): BS degree or international equivalent in a life science. 4 or more years of experience in Clinical Operations, Project Management, study startup, and trial optimization with evidence of increasingresponsibilitywithin a pharmaceutical company, CRO or relevantindustryvendor. At least 2 years of directresponsibility in site activation and managing the study startup processes of clinical research studies at a sponsor or CRO.

Experience and knowledge with country level ICF creation and

Requirements

. Proficiency with software models and database structures. Global SSU experiencepreferred Ability to explain data, facilitate decision making processes to be data driven.

Expertise in principlesdriving country/site startup and study startup strategies. The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot.

Teamworkand people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment.

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 upper body and neck.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance.

Varied hours may be required. Target Pay Range: $85-92k USD #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.Originally posted on Himalayas