Lead Start Up Specialist, FSP

Our FSP team is currently seeking aLead Study Start Up Specialistto 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, andmentoringto 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, andmodeling. 

• Createcountry-specific ICFsbased on the Master ICF provided. 

• Ensure standards are applied to thesite  startup process across project portfolios and support continuous improvement activities while developingthe process.. 

• Guide the collection and analysis of all data to influence study startup timelines. 

• Leverage leading industry tools and data sources to provide data onstartup 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 theinternal teamand monitor adherence to these. Promptly recognize and improve potentialdelays, and escalate non-performance. 

• Lead theinternalFSPsitestart 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 "ReadyToEnroll" to the Start Up Project Plan. Resolve escalated issues identified by the sitestart up-team in partnership with the Study Manager  

Qualifications & Experience Requirements (Minimum Required):

• BS degree or internationalequivalent in a life science. 

• 4 or moreyears ofexperience in Clinical Operations, Project Management, study startup, and trialoptimization withevidence ofincreasingresponsibilitywithin apharmaceutical company, CRO orrelevantindustryvendor. 

• Atleast 2years ofdirectresponsibility in siteactivation andmanaging the study startupprocesses of clinicalresearch studiesat a sponsor or CRO. 

• Experience and knowledgewith countrylevel ICFcreation andrequirements. 

• Proficiency with software models and databasestructures. 

• Global SSUexperiencepreferred 

• Ability toexplain data, facilitatedecision makingprocesses to be datadriven. 

• Expertise inprinciplesdriving 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.