Senior Clinical Data Management Programmer
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Summary
Leads in the evaluation, implementation and validation of package systems to support Clinical Database review requests of all Clinical Database applications. Creates, maintains and oversees process for providing end user support for all Data review and ad hoc listings. Works very closely with Clinical Data Managers to develop study specifications listings and gain acceptance through user testing. Develops data quality listings to comply with related specifications and regulatory requirements. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance, and company SOPs. Communicates programming and related document review statuses to management and the project teams.
Primary Responsibilities
Lead the development, validation, and maintenance of clinical reporting of clinical trials using a variety of validated software applications
Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management documentation.
Develop a variety of SAS/Data review/Visualization reports by integrating various sources of Data for efficient Clinical Data review and decision making
Implement and test data quality checks in accordance with the study database specification listings.
Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data)
Serve as SME and facilitate integration of EDC systems to other clinical platforms such as CTMS, Reporting, and IRT as needed
Assist in managing and providing listings to all medical coding dictionaries, including but not limited to MedDRA and WHODrug
Oversee the management of Clinical report development, other GxP system user accounts and other help desk activities within Clinical reporting areas
Develop EDC report listings, work with EDC vendors to resolve, and escalate issues appropriately to Senior Management.
Work very closely with other functions to support ad hoc report development using tools such as Python, R Programming, Power BI, etc.
Quickly learn new and/or advancements in software to become the SME for any technical question
Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary
Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance)
Keep management team abreast of issues, progress, and risks related to trial operations
Support bid defenses from a technical SME perspective
Providing proactive ideas, support developing Insightful reports for supporting Data review process,
Participate in other clinical programming and data management activities, as required
Participate in internal and external team meetings, as required
Mentor junior level clinical programmers
Adhere to all aspects of the Statistics & Data Corporation s quality system
Comply with Statistics & Data Corporation s data integrity & business ethics requirements
Perform other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at SDC to maintain compliance with business and regulatory requirements.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Skills
Excellent understanding of relational database structures
Fast, accurate programming skills using assorted application software
SAS, R Programming, Python, PL/SQL, SQL, and