Senior Clinical Programmer

3 weeks ago

india Cytel Full time

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Senior Clinical Programmer (Quality/Technical Review) role 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.

Summary of Job Responsibilities:

Conducts technical review and QC of clinical programming deliverables from internal and vendor employees. Provides analysis and trending of quality to management, feedback, and training to internal and vendor employees as needed. Performs additional clinical programming tasks including but not limited to data loading and report creation. Works with the requestor to define requirements and performs QCs programming. If required, reviews or creates user acceptance test scripts for quality and completeness. Performs UAT process to ensure high-quality results, feedback, and compliance with industry and client best practices.

Minimum Experience Requirements:

Minimum of 5 to 8 years of Clinical Data Management or database/statistical programming experience working in the biotechnology or pharmaceutical industry; work with CROs is highly desirable.

Technical/Software Skills: Expertise with Oracle Clinical/Medidata RAVE/Inform/eCOA and/or other clinical data management software; Expertise with Business Objects or Elluminate reporting tool is preferred; Expertise in SQL; detailed understanding of Oracle Clinical database structures. MS Office, Visio, familiarity with medical coding dictionaries especially MedDRA and WHODrug.

Experience applying best practices in clinical data management or database/statistical programming in the clinical trial environment, including requirements definition and QC plans. Knowledge of GCP and other regulations. Experience working in an Elluminate reporting tool is preferable. 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 or Master in Life Sciences, Clinical Data Management, Computer Science, Medical Informatics or equivalent degree.

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