Senior Specialist Study Management

Job Description:Primarily responsible for coordinating the study start-up for in-house clinical trials. Works as part of a clinical delivery team providing support, guidance and advice on a local level. Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery. Able to solve complex problems within a range of studies. A self-starter who is able to navigate study start-up for multiple clinical trials independently.The candidate must be able to work standard US business hours in any time zoneThe person will manage a set list of study sites—some with ongoing start-up, some brand new—responsible for all regulatory document collection and coordination at each site (including IRB/ethics committee submissions)Must handle vendor management: engage vendors, coordinate site training with systems, and arrange start dates for vendorsExperience as a Study Startup Lead is highly valued; the more experience in this area the betterTechnical skills required include IRB submissions and packet preparation, essential document collection, and any site or study startup tasksMust be able to operate independently with almost no guidance after initial system training; immediate ability to contribute is neededEducation & Skills required:Education: Bachelor’s degree required; Master’s or higher not necessaryIdeal experience: 3-5 years, but flexible if a candidate is otherwise a good fitStudy Startup Lead experienceIRB submissions and essential regulatory document management/collectionVendor management for study and site startupAbility to work independently with minimal guidanceTeam-oriented attitude and willingness to help out broadlyThe position is remote, temporary (6 months) assignment only.