Neurocrine

Neurocrine

Clinical Compliance Manager

US CA San Diego

Sponsorship not specified$131k-$179kDetected 15 days ago
GCPComplianceProject ManagementClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

  • Serves as a key ClinOps liaison, adept at identifying procedural gaps and championing innovative solutions to enhance efficiency and effectiveness across clinical processes. _
  • Your Contributions (include, but are not limited to):
  • Guides study teams on audit/inspection activities, offering insights on findings, and escalating issues to Clinical Compliance (CC) Director when necessary

Responsibilities

  • Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness.
  • Develops and reviews new or updated ClinOps controlled documents, coordinate input from Subject Matter Experts (SMEs), assess impact, propose implementation plans, and manage timelines

Requirements

  • Master's degree life science or related field AND 4+ years of similar experience noted above
  • Proven expertise in audit/inspection-related activities, Good Clinical Practices (GCP), and regulatory compliance, and inspection readiness
  • Strong leadership and collaboration skills, with a track record of effectively leading and supporting cross-functional teams
  • Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders
  • Proficiency in both collaborative and independent work, with the capability to mentor and lead junior team members
  • Comprehensive project management expertise, including resource allocation, timeline governance, and risk mitigation strategies
  • Working knowledge of Clinical Operations, specifically conducting clinical studies from start-up through close-out
  • Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

Nice to have

  • BS/BA degree in life science or related field AND 6+ years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry.
  • Previous experience as a Clinical Trial Associate (CRA), Clinical Trial Manager (CTM) or Clinical Research Coordinator, or equivalent, preferred OR
  • Excellent computer skills.
  • Experience with Veeva Vault preferred

Compensation

  • The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00.

Company info

  • Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
  • About the Role:
  • Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Plays a pivotal role in shaping and implementing process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees the facilitation of training and the creation and revision of controlled documents to ensure operational excellence. Serves as a key ClinOps liaison, adept at identifying procedural gaps and championing innovative solutions to enhance efficiency and effectiveness across clinical processes. _
  • Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs.
  • We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders.
  • The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
  • to relieve suffering for people with great needs.
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