Global Pharmaceutical Company out of Madison, NJ and Irvine, CA
Position Summary: (Irvine, CA or Madison, NJ)
Responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report form (eCRF) systems (e.g. InForm, etc.), external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, J-Review), and other programs (e.g. SQL, PL-SQL, SAS, APEX, etc.).
Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.
Responsible for the role which includes implementation of data capture systems and methods, member of the CRF Review Team, providing ongoing support to data capture, and generation of reports for use in ongoing data review and reconciliation. Provides leadership and content expertise for programming activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
Responsible for the role which includes integration, aggregation and delivery of clinical study data. Work with external vendor on data acquisitions and peer review of deliverables and maintain technical interface with external data providers.
In addition, the incumbent is the key contact for Clinical Data Management, Research & Development Quality Information Technology (RDQIT), Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology(GPSE), Clinical Development, and Non-Translational Sciences (NTS).
Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Programming tasks. Drives and contributes to continuous improvement. Delivering training to Clinical Programming and other functions/departments as necessary. Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Programming staff. Supports Corrective and Preventative (CAPA) Action initiatives as needed.
Bachelor’s Degree with demonstrated ability in Clinical Research, Computer Science, Project Management or related field.
Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting).
Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials.
Strong knowledge of global standards related to clinical programming activities (data standards, database design, coding and coding dictionaries, etc.).
Strong ability to work in a matrix environment and communicate effectively with different functional groups across the organization.
Strong ability to foster open communication and practice active listening to encourage a collaborative team environment.
Demonstrates a solution oriented approach to problem solving and a “can do” attitude.