Clinical Data System Lead II / Senior Analyst

• Should have hands on experience in EDC-Medidata Rave / any other clinical EDC system clinical database & setting up EDC-Veeva CDMS/Medidata RAVE studies and program edit checks/dynamics per specifications and accountable for on time deliverables.
• Able to read, understand the protocol and transcribe into the specs. Convey specs with study team, collect input, design/program forms/dynamics checks for the study in Rave. Perform unit testing, share EDC screen and walk-through forms/design, and update as needed. Have understanding about UAT/testing documentation and approval process.
• Have an understanding about CDASH/CDISC terminology and global standard objects and common data standards used during setup.
• Consider having with Project Data manager skillset with hands on designing experience of EDC-Veeva CDMS/Medidata RAVE databases for clinical studies. Any other designing tool Oracle Central Designer/Inform, Veeva, Oracle PL/SQL, other programming language, understanding rational database would be plus for this role.
• 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 client 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 startup 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 Information Technology (RDIT), 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, efficiency, 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 with 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.
• 3+ years of experience.

• Rave Medidata – Must have hands-on deep knowledge of study design.
• Protocol reading and visit structure understanding.
• CDASH / SDTM control terminology and understanding about Domain/Variable OIDs.
• Coordination with study team/Data Manager and gathering eCRF requirement and management skillset. Capability to coordinate across departments and communicate issues/resolutions.
• Knowledge about eCRF standardization and library concept skillset. Knowledge about study data, reporting, and departmental structure.
• We are looking for EDC-Rave Medidata System Designer/Programmer. Not Manager or oversight role.

Katalyst HealthCares & Life Sciences