Database Programmer (Data Manager) Contract
Excellent Rates| Milano| Contract/Interim
Database Programmer 6 Month Contract
The Database Programmer participates in design, development, validation, implementation, and provides ongoing support for electronic clinical data systems including Electronic Data Capture (EDC) systems, reporting tools, and clinical data system integrations such as randomization and EDC. Provides functional technical leadership and acts as a Subject Matter Expert (SME) with responsibility for delivering EDC technical services and management of data within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data.
Database Programmer staff will be responsible for managing smaller and less complex projects and serve as the lead programmer on the study team. They may be asked to provide full database programming services for these studies or to help out on larger more complicated tasks where they can assist Sr Database Programmers or where they can participate by testing or writing specifications. Database Programmers may be asked to participate in process improvement initiatives.
- Analyze clinical study design requirements and create system specifications to support the implementation of electronic systems used in clinical studies.
- Assist in the validation/ User Acceptance Testing (UAT) of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.
- Responsible for development, peer review and maintenance of database systems and tools to support delivery of global clinical trials.
- Assist with definition, capture and delivery of clinical study data. Peer review of database programming deliverables.
- 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 development and finalization of the EDC database according to the study specifications (e.g. Protocol, Data Management Plan, Data Review Plan or Edit Specifications).
- Responsible for participation in the identification, evaluation, recommendation, implementation and management of clinical information technology solutions to support clinical study operations 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. Create and maintain library of standard templates and practices, specifications, documents, meetings, reports, tools, etc. for use by DM and study teams.
- Liaise with Quality Assurance on EDC systems Corrective Action and Preventative Actions (CAPA) and/or Incident Reports (IRs).
- Provide project team EDC support in the initiation of EDC studies and facilitate EDC implementation through the start up Phase.
- Oversee and facilitate study UAT process by acting as UAT Facilitator as needed.
- Oversee mid-study changes in study conduct phase until study close.
- Work with EDC vendors, facilitate direct communication among Database Programmers, Project Managers and Project Data Managers.
- Measure vendor performance, conduct Lessons Learned, implement vendor process improvements, and evaluate/audit EDC vendors.
- Facilitate issue resolution/issue escalation as relates to clinical data issues.
- Create and analyze metrics reports and key indicators to measure vendor performance and standards improvements.
- Facilitate, review and approve EDC training plan and training curriculum.
- Attend Investigator Meetings to assist in and evaluate EDC training.
- Participate in Electronic SAE (eSAE) system development, other integration processes (CTMS, IVRS, ePRO, ARISg, etc.), and study level data integrations.
- Implement Process enhancements in EDC implementation procedures.
- Conduct cross-functional process training workshops.
- Conduct and facilitate gap training forums in software version upgrades.
Education Experience / Certification
- Previous experience building eCRF databases preferably within a medium-large Pharma or CRO with experience at the minimums noted below:
*Sr Database Programmer
*Sr Database Programmer should have a track record of demonstrating increasing responsibility for leading the eCRF database build activities for clinical studies
- Previous experience working with EDC systems (e.g. Medidata Rave, MedNet, Oracle InForm)
- Previous experience working with reporting/business Intelligence tools (e.g. Business Objects, Spotfire)
- Technical abilities and skills in analysis, design, specification and programming of computer systems
- Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical studies
- Analytical, problem solving and technical skills and attention to detail with high quality outputs
- Knowledge of clinical data management (eCRF/CRF design, data standards, database design, coding and coding dictionaries, etc.) and clinical programming methodologies as well as current and emerging global industry standards