Sr. Clinical Trials Manager
vor 1 Monat
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, 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 suffering for people with great needs, but few options.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid
- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit
, and follow the company on
LinkedIn
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X (Formerly Twitter)
and
Facebook
- (*_in collaboration with AbbVie_)
About the Role:
Contribute to overall clinical trial strategy and responsible for managing the operational activities to support planning, initiation, conduct and close out phases of clinical studies. Leads and manages the end-to-end operational activities of assigned Clinical Studies (domestic and global studies). Manages studies using multiple Contract Research Organizations (CROs) as well as managing internally run studies. Responsible for integrity of clinical trial data and completeness of Trial Master File (TMF) documentation.
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Your Contributions (include, but are not limited to):
- Responsible for developing, leading and managing NBI trials on an end-to-end basis and contribute to the overall trial study strategy and planning- Serves as primary point of contact for clinical operations aspects of assigned clinical studies, may oversee other clinical trials assigned to lower level team members- Participates, and may lead, in technical and study design discussions and provides expert level counsel and input to clinical trial outlines, protocols, and clinical study reports- Manages multiple contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies- Oversees study team meetings and manages study issues. Develops and manages study timelines in accordance with corporate goals. Identifies barriers to enrollment and develops recruitment solutions- Manages internally run studies (without CROs) including the management of trial monitoring team(s) and develops various study plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary- Works collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs- Manages Trial Master File (TMF) content ensuring all study documents are appropriately filed and inspection ready throughout the conduct of the study as well as at study completion- Ensures 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-
- May support the recruitment, training, management, and career development of subordinates within the clinical operations group- Other duties as assigned
Requirements:
- Expert knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive- Excellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out and understands clinical development efforts of trials- Strong understanding of trial development and extensive trial management protocol and process knowledge across all phases of clinical studies- In-depth understanding of Clinical Research industry and the relevant environments in which it operates- Ability to identify and organize clinical resources needed to accomplish major projects, set overall trial(s) objectives and provide clear direction to others; expertise planning activities in advance and taking account of possible changing circumstances; manages time effectively- Must possess strong presentation and communication skills for internal and external presentations- Strong computer skills, organizational skills, interpersonal and team participation skills are essential- Anticipates business and industry issues; recommends relevant process / technical / service improvemen
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