Specialist, Clinical Trials 5/2/2020
San Diego, CA
JOB DESCRIPTIONAPPLY WHO WE ARE:
At Neurocrine Biosciences, we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.
WHAT WE DO:
Neurocrine Biosciences (Nasdaq: NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems.
The company s diverse portfolio includes two FDA-approved treatments INGREZZA (valbenazine) for tardive dyskinesia and ORILISSA (elagolix) for endometriosis*, as well as clinical development programs in multiple therapeutic areas, including Parkinson s disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome.* As part of a strategic collaboration with Voyager Therapeutics, Neurocrine Biosciences is also focused on the development of investigational gene therapy programs for the treatment of severe neurological diseases, including Parkinson s disease and Friedreich s ataxia. (*in collaboration with AbbVie)
ABOUT THE ROLE:
Among other responsibilities, the Specialist, Clinical Trials supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). This individual is a key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies.
YOUR CONTRIBUTIONS (INCLUDE, BUT ARE NOT LIMITED TO):
* Working with the Clinical Trial Managers, helps ensure clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
* Serves as team member for of assigned clinical studies.
* Prepares data / information for technical and study design discussions.
* Provides administrative support, ensuring invoices are paid, tracking metrics, issues for contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies.
* Participates in study team meetings and tracks study issues. Under direction of the CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts.
* Participates in internally run studies (without CROs) including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary.
* Works collaboratively with clinical operations department in documenting NBI standard processes across assigned clinical programs.
* Other duties as assigned.
* BS/BA in Scientific field or equivalent and 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred, OR
* Master's degree in Scientific field or equivalent and some experience as noted above
* Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
* Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out.
* Some trial management protocol and process knowledge
* General understanding of Clinical Research industry and the relevant environments in which it operates
* Ability to plan activities and works well under changing circumstances; manages time effectively
* Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
* Works to improve tools and processes within functional area
* Ability to work as part of and lead multiple teams
* Strong computer skills
* Good communications, problem-solving, analytical thinking skills
* Sees impact on department
* Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
* Developing project management skills
* Ability at analyzing data and information to derive options/recommendations for management considerations
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.