Overview
Work as a senior data operations programmer on clinical and non-clinical trials; develop and maintain trial specific databases, including eCRF’s, edit Checks and Custom Functions using relevant programming languages of various levels of complexity to excellent quality whilst adhering to deliverable timelines. Creation of advanced custom programs as per Data Review Convention specifications as required. Program reports and listings which contribute to the standardization of process and reports used for data review and analysis for external partners/vendors. Develop and maintain CDASH compliant therapeutic area and global eCRF libraries ensuring efficient mapping to current SDTM standards. Good knowledge of CDISC CDASH and SDTM implementation guidelines. Excellent teamwork ethos, willingness to help others and learn new skills from working in a team environment.
Responsibilities
Employees may be required to perform some or all of the following:· Participate in study specific eCRF programming strategy meeting at study set up.· Perform senior review of database specification documents created by study teams, such as eCRF specifications and Data Review Convention specifications.· Build clinical study database CRF database screens per CRF/database specifications provided by the study team.· Create/Program edit checks, special action and derivations as per the Data Review Convention specifications.· Ensure non -eCRF technologies for data capture (e.g., ePRO, coding, IWRS/RTSM) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.· Work closely with the study team to ensure all programming issues are resolved in a timely manner.· Complete study database updates as specified per database modification documents and procedures.· Trouble-shoot, solve study-building issues, and edit check-programming issues.· Configure and program additional system features, as required.· Create advanced custom programs as per Data Review Convention specifications as required.· Program reports and listings and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors.· Perform senior review of critical document/deliverable (CDASH eCRFs, SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of the eCRF.· Lead the development and maintenance of CDASH compliant global eCRF libraries ensuring efficient mapping to current SDTM standards.· Lead the development, update and retiral of CDASH compliant therapeutic area eCRF libraries ensuring efficient mapping to current SDTM standards.· Work as part of a study team to produce quality data.· Take responsibility for data operations programming deliverables within reporting teams for complex studies.· Work independently as a database lead builder.· Support data operations study teams with archiving of study documentation: archiving trial databases.· Lead database build teams for projects of significant complexity to ensure quality and timely deliveries on Phastar projects or client studies.· Liaise with stakeholders to ensure successful project delivery.· Highlight/ give feedback to relevant line managers regarding any performance of team members.· Provide expert advice for Data Operations project innovation - report progress, risks and issues to senior management.· Resolve any obstacles for team members.· Lead the implementation, accreditation and validation tasks for new software required to conduct Data Operations tasks.· Perform risk and impact assessment of new releases to software and provide input into change management plans.· Prioritise quality in everything that you do. · Ensure the principles in the PHASTAR checklist are followed rigorously.· Help network for potential recruits as and when required and representing the company at external events and conferences and presenting at conferences.· Report any potential new business opportunities to the business development manager.· Be involved in bid defence and other sales meetings, including demonstration of data capture software solutions.· Actively offer PHASTAR services for potential new opportunities.· Bring changes to the attention of the company and be involved in updating processes.· Ensure we keep pace with industry developments by sharing knowledge of emerging technologies, processes and opportunities to build Phastar’s competitive advantage and improve efficiencies.· Proactively identify own areas for development / improvement and share knowledge through attending and presenting and the Phastar forums.· Help others as and when required, proactively assisting less experienced team members on an ad-hoc basis and training and mentoring less experienced team members.· Develop and deliver technical and data capture software training internally and externally.· Identify internal training needs and overseeing delivery of courses.· Maintain training record to accurately reflect course attendance.· Ensure clients (internal and external) remain engaged and well informed.· Maintaining a positive client relationship.· Develop good working relationships with data capture software vendors.· Receive and process feedback from project teams.· Implement approaches that will result in error-free results.· Understand and work to the company SOPs.· Implement GCP standards.· Create, review and update SOP and WINS.· Take responsibility for study compliance for processes and SOPs being followed· Identify areas where new SOPs are required.· Refine SOPs to ensure optimal procedures.· Support audits and inspections as required.
Qualifications
· University or college degree in Life Sciences, Mathematics, Computer Science or equivalent degree· At least 5 years’ experience in clinical database programming, setup of clinical databases and eCRF design, edit checks, Custom Function and Migration, gained in the pharmaceutical industry, CRO or Life science related industry· Certification in Medidata Rave EDC· Strong knowledge of C#· Knowledge of SAS· Knowledge of clinical data capture software or relational databases as applied to clinical trials· Knowledge and experience of the implementation of CDISC CDASH and SDTM Standards