Randstad Clinical Operations in Irvine, California
Wednesday, October 12, 2016
Randstad Life Sciences
Job Title: Sr Clinical Programmer Analyst
The Senior Clinical System Programmer (SCSP) employee must conduct work activities in compliance with all company internal requirements and with all applicable requirements. Company internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Under the direction of management the incumbent will lead the design, development, validation, implementation, and provide ongoing support of electronic systems (e.g., Oracle Clinical, Phase Forward), reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., PLISQL, SAS) used in Clinical Research and Development studies. Additionally, the (PCSP) will analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies. Will assist in the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.
Other activities, special projects and assignments may be given as required and the incumbent must conduct work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all company policies, and procedures. The company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Clinical Programmer: Responsible for 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.
Data Integration Programmer: Assist with the role which includes Integration, Aggregation and Delivery of Clinical Study Data. Peer review of deliverables. Creation of the Data Lineage Plan and main technical interface with the External data provider.
Global Librarian: Support for the role which includes maintenance of Global Libraries and ensuring their synchronization with department standards (e.g. Standard data Elements). Review new programming objects prior to their use for Study database set-up.
Vendor Selection and Management Team Member: Assist with the role which includes participating in the vendor selection process and managing the vendor in accordance with the approved Vendor Management Oversight Plan. Assessment/Re-assessment of vendor capabilities, as necessary.
AGN Personnel / 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.
BA/BS degree or equivalent experience in Computer Science, Life Science or related field required.
BS/BA degree with 6 min. years experience, or MS degree with min. 4 years experience.
Minimum 3 year experience within a clinical programming organization, preferably within medium-large pharma or CRO.
Intermediate knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
Intermediate knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
Advanced knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.).
Intermediate knowledge of Research & Development and an understanding of regulatory guidelines/requirements related toR & D (e.g., ICH, GCP, safety reporting).
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance