Manager, Clinical Programming in Southern California

Manager, Clinical Programming in Southern California

Tanner and Associates is recruiting a Manager, Clinical Programming to be based in Southern California. Please contact me for more information.

Manage internal and outsourced Clinical Programming personnel and activities in support of Clinical Research and Development studies. Manage the design, development, validation, implementation, and provide ongoing support for electronic systems (e.g., Clinical Data Repositories/Warehouses, Oracle Clinical, etc), reporting/business intelligence tools (e.g., Business Objects, Spotfire), and industry standard compliant datasets (e.g., CDISC SDTM) using ETL technologies (e.g., Informatica Powercenter) and programs (e.g., SAS, PL/SQL).

Analyze Clinical Study design requirements against third party system specifications to support the implementation of clinical systems. Support the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements. Manage the implementation of programming standards and conventions.

Responsible for document creation, development, peer review, validation, 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.

Responsible for integration, aggregation, delivery, and creation of technical documentation. Peer review of deliverables. Main technical interface with the External Data Providers. Creation of industry standard compliant Data Tabulation Datasets (e.g., CDISC SDTM).

Responsible for maintenance of Global Libraries and ensuring their synchronization with department standards (e.g. Standard Data Elements). Review and approval of new programming objects prior to their use for study database set-up.

Responsible for planning, organization, and management of all internal and external programming activities supporting clinical trials. Hire, train and manage performance of staff inclusive of orientation, training, personal development, completing and administering performance evaluations). Works closely with human resources to ensure timely hiring of qualified resources.

Responsible for developing procedures and documentation in support of the definition of, and project planning and requirements for study-specific program and software development.

Responsible for participating in the vendor selection process and managing the vendor as necessary.

Responsible for 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. Report process gaps and potential misconduct during clinical studies to management.

• Degree or equivalent experience in Computer Science, Life Science or related field: BS/BA degree with 9 years experience, or MS degree with 7 years experience, or PhD degree with 4 years experience.
• Minimum 4 years experience in a leadership role within a clinical programming organization, preferably within medium-large pharma or CRO.
• 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 (CDISC; SDTM), database design, coding and coding dictionaries, etc.).
• Ability to effectively interact with and influence others without direct reporting relationships
• Technical abilities and skills in the analysis, design, specification and programming of computer systems using tools such as Powercenter, SAS. Knowledge of UNIX, Oracle a plus.
• Technical writing skills and experience
• Planning, organizational, and project management skills