#R-211494
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 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 Practice
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Drug development and clinical trials processes
Data management processes
Clinical trial databases and applications
Study build and Edit check development
Programming Languages
Systems development lifecycle
Project planning and management
Collaborating with global cross-functional teams (team/matrix environment)
Quality management and Risk Analysis
Regulatory filings and inspections
Process improvement methodologies
Preferred Qualifications
Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline
Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
General project management and planning experience
Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, IRT vendors, etc.)
Basic Qualifications
Bachelors degree or equivalent in life science, computer science, business administration or related discipline
Specialist knowledge / experience in life sciences or a medically related field
General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
.