Responsibilities include, but are not limited to, the following :
- Support of clinical trial platform technologies
- Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.
- Coordinating and providing programming support to Clinical Study Teams
- Works collaboratively with Clinical Data Management to meet study deliverables and timelines
- Acting as a technical point of contact for systems deliverables on defined programs
- Experience in creating / programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation.
- Providing technical and business process input / expertise on new and emerging technologies
- Develop, review and implement policies, SOPs and associated documents
- Assist in preparing for and responding to audit findings (internal or external)
Knowledge
Good Clinical PracticeStrong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking.Drug development and clinical trials processesData management processesProgramming of clinical trial databases and applicationsProficient in SAS edit check programmingSystems development lifecycleProgramming LanguagesProject planning and managementCollaborating with global cross-functional teams (team / matrix environment)Quality management and Risk AnalysisRegulatory filings and inspectionsProcess improvement methodologiesWhat we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Preferred Qualifications
Advanced 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 (CRO's, central labs, imaging vendors, IRT vendors, etc.)Basic Qualifications
Bachelor's degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience.Master's degree and 4 to 6 years of experience.Specialist 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)Skills Required
Data Management, Vendor Management, System Development, Sas, drug development, Project Planning