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
- Ensure 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 programs
- Identify, 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 technologies
- Develop, review and implement policies, SOPs and associated documents
- Ensure 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).
Knowledge
Good 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 applicationsStudy build and Edit check developmentProgramming LanguagesSystems development lifecycleProject planning and managementCollaborating with global cross-functional teams (team / matrix environment)Quality management and Risk AnalysisRegulatory filings and inspectionsProcess improvement methodologiesPreferred Qualifications
Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline with 9+ years of experienceBroad 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 Qualifications
Bachelors degree or equivalent in life science, computer science, business administration or related disciplineSpecialist 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, Project Managment, Risk Management