Manager, CSAR

We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting.The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology.We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).Responsibilities include, but are not limited to, the following:Support of clinical trial platform technologiesSupport decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.Coordinating and providing programming support to Clinical Study TeamsEnsure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards.Acting as a technical point of contact for systems deliverables on defined programsIdentify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment.Providing technical and business process input / expertise on new and emerging technologiesDevelop, review and implement policies, SOPs and associated documentsEnsure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes.Assist in preparing for and responding to audit findings (internal or external).KnowledgeGood Clinical PracticeStrong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinkingDrug development and clinical trials processesData management processesClinical trial databases and applicationsEdit check development and Custom function programingProgramming LanguagesSystems development lifecycleProject planning and managementCollaborating with global cross-functional teams (team/matrix environment)Quality management and Risk AnalysisRegulatory filings and inspectionsProcess improvement methodologiesPreferred QualificationsAdvanced degree or equivalent in life science, computer science, math, statistics, business administration or related disciplineBroad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arenaGeneral project management and planning experienceExperience in oversight of outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.)Basic QualificationsBachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experienceSpecialist knowledge / experience in life sciences or a medically related fieldGeneral biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)