External Data Operations Principal Programmer (Data Management Resource II)
1 Astellas Way Northbrook, IL 60062
Purpose & Scope:
- Provides technical excellence to Data Management to standardize and streamline data checking and data cleaning of data received through other routes than the EDC system by developing appropriate tools and data standards.
- Oversees and/or provides technical support to Data Management and/or CRO to collect and check data received from external providers (e.g., central laboratories, ECG laboratories, and Biopharmaceutical laboratories).
- Oversees and/or provides specifications and creation of programs to check and ensure consistency between data received from external data providers and (e)CRF.
- Oversees or acts as intermediate between Data Management, Clinical Programming and external data provider regarding external data specifications data and technical issues.
- Arranges suitable interfaces and advises on system improvements
- Key contact for data standards related to external (laboratory) data
Essential Job Responsibilities:
Technical Excellence: Acts as an external data specialist (handling external data received from sources other than (e)CRF), and oversees junior team members, with the following job responsibilities:
- Creates and maintains standard specifications and standard programs/macros for external data vendors (e.g., central lab, PK, ECG). Defines specifications to automate reconciliation (i.e., create functional requirements for standard macros) and to create SAS programs to perform external data checks against the data transfers received for data reconciliation. At the end of the study, provides clean external data as SAS datasets as required by statistical programming for statistical analysis
- Assists junior team members with external data tasks when needed and oversees Contract/Clinical Research Organization (CRO) vendors performing external data tasks when applicable to ensure delivery of high quality output in line with agreed timelines. Provides expert level technical direction to less experienced team members in order to ensure the highest quality results.
- Assists and provides project and study level support for external data requests to study team and junior team members, such as investigating questions regarding safety lab data reported, handling protocol amendments affecting external data, and coordinating transfer schedules for data cut-off deliverables (e.g., dose escalation meetings). Checks quality of the data received and reconciles with (e)CRF data.
- May lead initiatives designed to improve the speed of data flow and quality of external data and/or guide other team members in executing these initiatives.
- Works with SAS programmers and electronic data capture (EDC) programmers, as well as external data vendors to design, build and implement interfaces between the external data vendor’ s systems and SAS or external data collection applications (e.g., ePRO) and SAS to further standardize and facilitate external data reconciliation.
- Works with data standards subject matter experts (SMEs) to ensure data transfer structures comply with standard data models. Makes significant contributions, or may lead, the development and maintenance of external data standards and the processes needed to support their use and evolution.
- Demonstrates breadth of knowledge across the entire clinical development life cycle, and understands how external data can be employed to improve quality, efficiency and cycle times.
People Development /Management: Provides guidance, advice and support to junior team members in providing best in class external data operations to support drug development programs. Acts as leader and leads by example.
Performance and Resource Management
- Contributes to the development of metrics and key performance indicators (KPIs) for measuring and monitoring performance standards.
- Works to established timelines and KPI goals. Follows required processes and utilizes standards. Suggests improvements as appropriate.
- Provides study oversight and ensures that all external data deliverables outsourced to CROs are delivered on time with quality. Reviews and analyzes KPIs and metric reports and discusses progress with study team and CRO vendors. Effectively escalates issues in line with agreed procedures.
- Provides new and innovative ideas regarding managing external data and/or reports and/or process that will improve efficiency, quality, and cost-effectiveness.
- Responsible for development and implementation of best in class standards, processes, and standard operating procedures (SOPs) in regards to external data operations applications.
Technology Development: Stays abreast of industry development with regard to external data operations and external data innovations.
- Responsible for adhering to quality standards and assisting other members of the team with adherence.
- Complies with established SOPs and EMA, FDA, and ICH regulations and policies.
- Collaborates with Global Clinical Science, Global Clinical Pharmacology & Exploratory Development, Medical Affairs, Health Economics and Outcomes Research, CRO vendors, and study team members to enable collection and use of clinical data.
- Partners with the Data Manager and other study team members to plan for success of study deliverables.
- Acts as key liaison between Data Management, Clinical Programming, Clinical and Biopharmaceutical/Bioanalytical Sciences and external data vendors.
Leadership: Inspires individuals for project and study delivery, and provides expert input into development programs.
Quantitative Dimensions: The External Data Operations Programmer provides technical support to Data Management for 1 – 6 studies depending on the status of each study and number of External Data Specifications per study (1-15).
Organizational Context: The External Data Operations Principal Programmer will report to the Senior Manager/Associate Director, External Data Operations.
- BS/BA in computer science or a related discipline. Combination of formal training and experience equivalent to the above may be considered.
- Generally, 8-10 plus years experience as a programmer within Data Management or SAS programmer with thorough knowledge of data flow and data reconciliation requirements
- Strong computer skills required, including knowledge of database management software
- Demonstrated experience using Medidata Rave from a front end data management user perspective. Back end user knowledge of Medidata Rave is desirable.
- Excellent communication skills and capability of working with individuals across multiple disciplines and projects.
- Strong organizational skills and be able to prioritize work for self and others to ensure timelines are met.
- Demonstrated interpersonal and project management skills.
- Use of Microsoft Office Suite (Word, Excel). Preferred
- Advanced experience using SAS, ORACLE and SQL
- Advanced experience using Crystal Reports, Business Objects and other business intelligence tools