Sr. Manager Document & Clinical Systems

Neurocrine Biosciencesis 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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons disease classic congenital adrenal hyperplasia hyperphagia in 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 and follow the company onLinkedInX Facebook and YouTube. (*in collaboration with AbbVie)

At Neurocrine strong leadership drives both business results and team success. We look for leaders who think strategically anticipate whats ahead and set clear direction while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful measurable impact through sound decision-making and accountability. Responsible for leading the strategy oversight quality compliance and operational execution of the electronic Trial Master File (eTMF) across one or more clinical development programs. Serves as the TMF subject matter expert (SME) and works cross-functionally with Clinical Operations CROs Functional Areas Quality Assurance Regulatory Affairs and Clinical Systems to ensure TMFs are inspection-ready throughout the lifecycle of each study.

Provides leadership for TMF processes vendor oversight inspection readiness metrics training and continuous process improvement while ensuring compliance with ICH-GCP FDA EMA MHRA and other global regulatory requirements.

• Leads mentors and develops junior team members by providing performance management coaching onboarding training and career development while ensuring successful delivery of study and departmental objectives

• Provides strategic leadership and oversight for TMF operations across assigned clinical studies ensuring timely compliant and inspection-ready TMFs through effective document management quality review remediation and query resolution

• Serves as the eTMF Subject Matter Expert (SME) providing strategic and technical guidance to study teams functional areas CROs vendors and end users while promoting TMF best practices and regulatory compliance

• Establishes and monitors departmental priorities work plans schedules resource allocation and key performance indicators to ensure achievement of business objectives and study milestones

• Builds and maintains strong cross-functional partnerships with Clinical Operations Regulatory Biometrics Pharmacovigilance Clinical Supply CROs vendors and other stakeholders to support successful TMF execution

• Leads TMF governance and study team meetings proactively communicating risks quality concerns compliance issues and recommendations to study teams and senior leadership

• Oversees TMF quality through health checks performance metrics trend analysis and continuous process improvement initiatives including development of SOPs work instructions training materials and sharing of lessons learned

• Leads internal and external audit and inspection readiness activities including facilitating inspections preparing responses overseeing CAPAs and ensuring timely resolution of TMF findings

• Applies expert knowledge of ICH-GCP global regulatory requirements industry standards and TMF best practices to ensure ongoing compliance and operational excellence

• Supports departmental and organizational initiatives special projects and other responsibilities as assigned

• BA/BS degree in life sciences or related field AND 8 years experience in clinical trial documentation clinical operations or related areas. Previous experience as a Clinical Trial Associate CRA Clinical Trial Manager CTM Research Coordinator or similiar strongly preferred. OR

• Masters degree in life sciences or related field AND 6 years experience as noted above

• Extensive experience in maintaining TMF documents and coordinating cross-departmental collaboration

• Excellent computer skills

• Advanced problem-solving and analytical thinking skills

• Ability to meet multiple deadlines with a high degree of accuracy and efficiency

• Strong 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

• Comprehensive understanding of regulatory requirements and standards in the biopharmaceutical industry with a commitment to ongoing learning and professional development

• Excellent organizational skills and detail oriented

• Strong leadership in both team settings and independent projects effectively managing direct reports with a coaching approach that helps junior team members develop their skills and advance their careers

• Comprehensive project management expertise including resource allocation timeline governance and risk mitigation strategies

• Strong knowledge of Clinical Operations specifically conducting clinical studies from start-up through close-out

• Expertise in audit/inspection-related activities Good Clinical Practices(GCP) and regulatory compliance and inspection readiness

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging respect and empowerment and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications dont line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $154500.00-$211000.00. Individual pay decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and addition this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match) paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans.