Neurocrine Biosciences · 1 day ago
Senior Clinical Trial Manager
San Diego, CA
Full-time
Onsite
Senior Level
$157K/yr - $214K/yr
6+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Senior Clinical Trial Manager will contribute to the overall clinical trial strategy and manage the operational activities to support the planning, initiation, conduct, and close out phases of clinical studies.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Incorporates Risk Based Monitoring with Clinical Quality Assurance counterparts to assure subject safety and data integrity across NBI Development Programs
May support the recruitment, training, management, and career development of subordinates within the clinical operations group
Other duties as assigned
Qualification
Required
BS/BA degree AND 8+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required OR
Master's AND 6+ years of similar experience noted above
Anticipates business and industry issues; recommends relevant process / technical / service improvements
Demonstrates broad expertise or unique knowledge
Considered an expert within the company and may have external presence in area of expertise
Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
Ability to work as part of and lead multiple teams
Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
Excellent computer skills
Excellent communications, problem-solving, analytical thinking skills
Sees broader picture and longer-term impact on division/company
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management, strong project leadership skills
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
Proven ability at analyzing data and information to derive conclusions and drive sound decision making
Works to improve tools and processes within functional area
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
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
Retirement savings plan (with company match)
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase