Senior Specialist Study Management
Zenith LifeScience, Gaithersburg, MD, United States
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 zone The 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 vendors Experience as a Study Startup Lead is highly valued; the more experience in this area the better Technical skills required include IRB submissions and packet preparation, essential document collection, and any site or study startup tasks Must be able to operate independently with almost no guidance after initial system training; immediate ability to contribute is needed
Education & Skills required:
Education: Bachelor’s degree required; Master’s or higher not necessary Ideal experience: 3-5 years, but flexible if a candidate is otherwise a good fit Study Startup Lead experience IRB submissions and essential regulatory document management/collection Vendor management for study and site startup Ability to work independently with minimal guidance Team-oriented attitude and willingness to help out broadly
The position is remote, temporary (6 months) assignment only.
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 zone The 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 vendors Experience as a Study Startup Lead is highly valued; the more experience in this area the better Technical skills required include IRB submissions and packet preparation, essential document collection, and any site or study startup tasks Must be able to operate independently with almost no guidance after initial system training; immediate ability to contribute is needed
Education & Skills required:
Education: Bachelor’s degree required; Master’s or higher not necessary Ideal experience: 3-5 years, but flexible if a candidate is otherwise a good fit Study Startup Lead experience IRB submissions and essential regulatory document management/collection Vendor management for study and site startup Ability to work independently with minimal guidance Team-oriented attitude and willingness to help out broadly
The position is remote, temporary (6 months) assignment only.