Senior Database Programmer

Accountability Supporting Activities

Documentation • Utilize current study documentation including the Protocol, Independent Reviewer Charter (Assessment criteria) / Reviewer Manual, eCRF, QC guidelines etc

• Participates in preparation of Data Operations Plan (DOP), maintains DOP throughout lifecycle of study project and ensures DOP is followed according to study design and requirements.

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory

compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.

• Maintain Study level technical documentation.

Setup • Build and execute project specific requirements at study level in standard format.

• Maintain consistency in programming by understanding standard regulatory requirements.

• Accountable for first time quality on all deliverables.

• Develop database (DB) Imaging trial data specifications, edit rules/checks, query logic and data validations.

• Reconcile electronic data transfers from vendor to Sponsor.

• Provide technical support and advice to the internal team.

Support • Assist in providing technical and domain level solutions to internal or external sponsor queries.

• Develop wider knowledge in Imaging Systems and reporting along with other programming language usage and process within PSG.

• Ensure adherence to SLA with respect to turnaround time once specifications are finalized.

• Involved in training and extending support to the new members joining the data management group.

• Participate in the creation of standards, either through tools, libraries or

processes, as required for IDO to ensure efficient, effective and

optimal processes.

Act as SME • Provide relevant training and mentorship to staff and project teams as

appropriate.

• Assist project teams in the resolution of problems encountered in the

conduct of their daily work.

• Assist in providing technical solutions to internal or external client

enquires.

• Maintain and expand local and international regulatory knowledge within the clinical industry.Qualifications• Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner

• Excellent interpersonal, verbal and written communication skills

• A flexible attitude with respect to work assignments and new learning

• Critical thinking to evaluate information gathered from multiple sources, reconcile conflicts, and decompose high-level information into details

• Affinity for logical thinking as would be applied in a software environment

• Ability to work together with a team as well as independently.

• Solid understanding of relational database concepts

• Proficiency in SQL exposure within Oracle, DB2, or SQL Server (Oracle preferred)

• Must be very organized and have ability to multi-task.

• Working experience or Knowledge SAS

• Experience working within a formal SDLC is preferred

• FDA 21 CFR Part 11 knowledge is preferred

• Demonstrate commitment to refine quality processes.

• Relevant clinical trial industry experience.