Clinical Programmer/Clinical Database Programmer

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Ihre Aufgaben

Clinical Programming Analyst is responsible for contributing to the assessment and tracking of the quality of programming tasks and activities executed by CRO and FSP vendors performing clinical trial programming work. The position collaborates with the BIOMETRICS staff, management, and vendor clinical programmers to schedule and conduct the review of study documentation and programming quality related to the design and testing of electronic data capture systems including eCOA and EDC databases, to ensure that all clinical trial databases and electronic collection tools are consistent with the needs of the study protocol and department standards and procedures. He/She collaborates closely with BIOMETRICS Data and Analytics Leads to plan timelines and workload to ensure deliverables are met across the client portfolio. He/She performs additional clinical programming tasks including but not limited to data loading and report creation.,

• Conducts peer review and QC of clinical programming deliverables from internal and vendor employees, providing analysis and trending of quality to management and feedback and training to internal and vendor employees as needed

• Reviews or creates user acceptance test scripts for quality and completeness and performs UAT process to ensure high-quality results, feedback, and compliance with industry and client best practices.

• Performs additional clinical programming tasks including but not limited to data loading and report creation. Works with the requestor to define requirements and performs or QCs programming

Ihr Profil

• Minimum of 5 years of Clinical Data Management or statistical programming experience working in the biotechnology or pharmaceutical industry; work with CROs highly desirable

• Technical/Software Skills: Expertise with Oracle Clinical/Medidata RAVE/Inform and/or other clinical data management software; Expertise with Business Objects or other reporting tool; Expertise in SQL, PL/SQL; detailed understanding of Oracle Clinical database structures. General software skills: Lotus Notes, MS Access, MS Word, MS Excel, MS Project, Visio, familiarity with medical coding dictionaries, especially MedDRA and WHO.

• Experience applying best practices in clinical data management or statistical programming in the clinical trial environment, including requirements definition and QC plans

• Knowledge of GCP and other regulations.

• Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, ability to develop trust, shared goals, and values.

• Collaborative, with negotiation skills, conceptual thinking, systems process thinking, accountability to deliverables milestones, and conflict resolution (internal and external).

• Must have excellent oral and written communication/presentation/negotiation skills.

• Detail-oriented, able to identify issues and consistently collaborate to solve problems in a timely manner.

• Ability to handle multiple (changing) priorities under tight timelines

  Minimum Education Requirements:

• Bachelor's degree required, Masters or PhD in Biology / Chemistry, Life Sciences, Clinical Data Management, or Drug Development preferred, BS in biological sciences, computer sciences, or other related fields