General Description of the Role
The essential role of the Clinical Studies Manager (CSM) is to support the day-to-day clinical research portfolio of the Guthy-Jackson Charitable Foundation (GJCF) International Clinical Consortium to advance the prevention, diagnosis, treatment and eventual cure of Neuromyelitis Optica (NMO) and NMO Spectrum Disease (NMO/SD).
Requirement: This is a full-time position, located in The Guthy-Jackson Charitable Foundation Operations office in San Diego, CA. Applicants who state they can meet this requirement will be considered.
The Clinical Studies Manager (CSM) will collaborate with and report to the GJCF leadership team and foundation contractors on a multi-center clinical research study titled “Collaborative International Research in Clinical and Longitudinal Experience in NMO Studies (CIRCLES).” The CSM will closely interact with a consortium of clinical researchers, database experts, and healthcare professionals, as well as participating organizations.
Duties and Responsibilities
• Serve as the GJCF reporting point of contact for CIRCLES and assist in identifying any issues or inefficiencies and propose effective solutions to the GJCF Executive Team.
• Apply clinical research expertise to facilitate the highly efficient coordination of an NMO Clinical Research Network to support CIRCLES.
• Engage in real-time peer-level relationships with client team/s, including the clinical research consortium, third-party commercial laboratory(ies) and data teams, and other partners to assure timely and accurate implementation of protocols, policies, procedures, and best practices in the CIRCLES study.
• Assist in strategic and operational planning and support quality assurance policies of CIRCLES.
• Liaise with a Data Coordinating Center and related biostatisticians and bioinformatics groups dedicated to providing optimal methodological, statistical, and project management support to appropriate clinical research projects and facilitate access to high-quality data for timely decision-making and goal achievement in CIRCLES.
• Liaise as a representative of the Foundation with a contract research organization to ensure clinical site monitoring is progressing in the CIRCLES study.
• Support the GJCF Executive Team by providing strategic input and recommendations regarding opportunities for breakthrough clinical advances to address unmet patient needs in NMO.
• Engage with Foundation Advisors and others to assist in stakeholder stewardship and development strategies.
• Liaise with multi-stakeholder teams through all phases of translational research to advance industry-sponsored clinical trials
• Support the Foundation NMOtion Advocacy Program to raise awareness about unmet needs and innovative solutions in NMO and related demyelinating diseases.
Experience: Minimum of 10 years related experience in translational science and translational medicine.
The ideal candidate will have demonstrated experience and expertise in the interface of clinical research, laboratory sciences, clinical trials & the industry development process.
Degrees, Licensure, and/or Certification:
Advanced degree in clinical laboratory science, clinical outcomes research, epidemiology, or closely-related field desired; a thorough knowledge of good clinical practice (GCP) and biorepository science is a plus.
Previous Experience: Must have expertise in clinical research and clinical study design and implementation, medical monitoring experience, as well as demonstrated knowledge of all applicable Federal and/or International guidelines and regulations.
Must have excellent communication skills and outstanding professional diplomacy.
Must have a minimum of ten years of clinical trial