Database programmer job description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!

The Clinical Database Programmer II, CDP II will work under the supervision of Senior CDP or above but may work independently as project lead. Working closely with members of Data Management, Statistics, Information Technology (IT), and Quality Control (QC) Departments, the CDP II is responsible for the design and the development of electronic or paper Case Report Forms and performs set-up of study EDC databases using company's clinical data management systems. The CDP II creates, revises and/or approves all applicable supporting documents per quality processes, and maintains and develops processes that support team, department, and group activities.

Develops reports and data validation outputs (listings) to support data management cleaning activities, and also data import programs based on data transfer specifications. Executes activities and assignments within scope, budget, and timelines, and adheres to ICH guidelines for Good Clinical Practice and other national and international standards and legislation (as required), and company procedures.



As a Clinical Database Programmer II You Will...


Perform the design and the development of eCRFs/CRFs. Review protocol, and/or synopsis, and other information provided to prepare and design the eCRF/CRF. Undertake review of, and contribute feedback towards, development of specifications for CDMS components as required by process. Undertake peer review of peer's work as required by process. Ensure eCRF/CRF Designs and Study Set-Up tasks are in compliance with existing industry regulations & guidelines, Company SOPs processes, company guidance. Develop Database Validations (Edit checks) to accompany eCRFs for studies. Attend project & client meetings as required by project scope and budget. Liaise and communicate with sponsor representatives as appropriate to ensure process, timelines and budget adherence. Prioritize tasks in conjunction with key milestones, providing regular feedback on progress to Project & Data Managers. Contribute to and maintain processes, SOPS, manuals, technical documentation and guidance on processes and systems. Liaise with relevant internal functions or client representatives to ensure process adherence. Support helpdesk activities for proprietary CDMS. Liaise with relevant internal functions and sponsor representatives to ensure timelines agreement and adherence. Input into timeline creation. Liaise with relevant internal functions and sponsor representatives to ensure budget adherence. Input into amendment costing estimates. Raise any out of scopes to Project Manager and lead DM. Complete assigned training on time. Contribute to identification of training requirements & support creation and delivery of training as required. Support group initiatives as appropriate to improve process, systems, technical capabilities and group knowledge. Lead group initiatives as appropriate to improve process, systems, technical capabilities and group knowledge. Provide ad-hoc technical support for CDMS as required. Contribute to SME groups for CDMS and/or specific CDMS tools and add-ons. Develop data validation outputs using required programming languages (e.g. SAS). Enhance efficiency of Design and compliance to industry standard data models by adhering to use of standards where possible. Define and develop import programs as necessary to inject vendor data files into company clinical data repositories and/or other related systems and databases, or data files of a standardized format (for example SAS datasets). Run and manage ad-hoc or planned EDC study reports. May support DM activities such as DB cleaning, external reconciliation and EDC roles and sites admin. Assist with User Acceptance Testing. Participate in bid defenses. Develop and review the EDC library. URL and study team Admin. Participate in ad hoc tasks as required per project or management.
Experience & Minimum Requirements:


Bachelor's degree or equivalent (preferred in science) or equivalent work experience. 3 years of industry and sector experience in eCRF design and development with commercially available CDMS, for example Medidata Rave, Oracle InForm/ Central Designer, Veeva, DataLabs, Medrio, IBM Clinical required. 2 years of experience leading projects required. Prior experienced in clinical research setting strongly preferred. General knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines preferred. Familiar and proficient in use of computer software such as MS Word, Excel, PowerPoint, with the ability to learn new applications.
Under the supervision of Senior CDP or above, but may work independently as project lead.
Leads complex studies.
Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.


#LIRemote
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.