The Clinical Data Integration Programmer within Clinical Programming under the direction of management will lead the acquisition, transformation, integration, specification, validation, implementation, and ongoing support of clinical research and development data from multiple sources using ETL technologies (e.g., Informatica PowerCenter) and programs (e.g., SAS, PL/SQL) into target electronic systems (e.g., Clinical Data Repositories/Warehouses, Data Tabulation Datasets i.e., CDISC SDTM) used in Clinical Research and Development studies. Lead the development of clinical study design requirements against industry standards to deliver compliant datasets (e.g., CDISC SDTM). Support the implementation of electronic systems implemented internally or through external vendors according to regulatory requirements. Support clinical information delivery via dashboards and reports ( Business Objects).
The consultant is expected to be skilled in performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the consultant is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The consultant must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all companies policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Data Integration Programmer
Responsible for the role which includes acquisition, integration, and delivery of Clinical Study Data. Documentation and peer review of deliverables.
Assist with the role which includes development, peer review and maintenance of database systems and tools to support Clinical Research activities. Provide leadership and content expertise for programming activities from startup through the statistical analysis stage of clinical studies in support of Global Development to effectively manage data capture, review and database lock activities.
Subject Matter Expert
Responsible for the role which includes participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities including all forms of electronic data capture through in-house or third party vendors. Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions. Support Corrective Action and Preventive Action initiatives. Report process gaps and potential misconduct during clinical studies to management.
Desired Candidate Profile:
Degree or equivalent experience in Computer Science, Life Science or related field: BS/BA degree with 6 years experience, or MS degree with 4 years experience.
Minimum 2 year experience within a clinical programming organization, preferably within medium-large pharma or CRO.
Informatica ETL development experience required.
Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies.
Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards.
Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.)
Ability to effectively interact with and influence others without direct reporting relationships.
Technical abilities and skills in analysis, design, specification and programming of computer systems.
Analytical, problem solving and technical skills.
Planning, organizational, and project management skills.
Attention to detail with high quality outputs.
Computer skills (word processing, spreadsheets, graphics, PowerPoint).
Competencies and skills in the following:
- cross functional relationships
- decision making
- execution/results/process improvement
- customer satisfaction
Qualified candidates can forward their updated resume along with cover letter to firstname.lastname@example.org or Fill up Quick Apply Form .