Senior Technical Data Management Specialist
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a talented and energetic Senior Technical Data Management Specialist to join our team! Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
Responsible for technical leadership and delivery of integrated data/solutions for clinical trials, from start-up to study completion, as well as technical oversight and partnership with data vendors.
ROLES AND RESPONSIBILITIES
- Drives efficient and high quality technical data delivery, and oversees data integrations working closely with clinical operations, data management, SAS programming, Statistics, and data vendors on various clinical projects, triaging issues, risks and performance with data delivery through systems and technology
- Drives successful data delivery through coordination of data vendor efforts (one vendor or across multiple vendors), in conjunction with DM Lead
- Assists in the identification and management of innovative electronic data collection from external data sources; liaises with vendors to assure efficient and high quality data delivery
- Works closely with Data Management and Programming leads to create standard and/or custom, reports and analytics to facilitate data oversight and review.
- Provides technical input to development and maintenance of Data Standards libraries
- Provides leadership, testing, training, guidance, and support to other department members on optimal integrated data solutions, using expanded technical skills, including impact and risk/assessments due to introduction of new technology or major/minor system releases
- Supports data delivery and technical solutions initiatives for Data Management and other operating groups bridging activities, meetings, discussions or support of other technology-based initiatives including but not limited to EDC, IxRS, ePRO, eSource, etc.
- Supports effective cross-functional relationships and oversight of technical data improvements including the necessary support and/or communication of activities, decisions and initiatives
- Provides technical supports to ensure effective relationships and oversight/partnership with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships, and participation in CRO/vendor selection for clinical trial systems, technologies, services and software
- Supports the development and delivery of key systems and technology performance indicators, metrics, deliverables and timelines
- Works closely with functional and quality representatives in appropriate validation plans and documentation, including implementation of risk quality management best practices and approach
- May participate in translation of protocol requirements into discrete data collection expectations in eCRF modeling, DB specifications and data transfer specifications at Study level and with Program level view and awareness of SDTM and other data collection standards; works with and oversees EDC vendor on database build activities
- May participate in the drafting and maintenance of robust data cleaning specifications including data flows, DB edit checks, critical variables list, manual listing specification, external data reconciliation, SAS edit checks specification and patient profile specification
- Other responsibilities as needed.
- Bachelors Science Degree in Computer Science, degree in relevant technical field or equivalent technical experience
- Minimum of 8 years’ experience in data management, business process support, programming, technical support, program design, database design/ development/management or any combination thereof, or alternatively, must have proven experience in all primary job functions
- Strong analytical skillset with a high level of comfort sourcing, manipulating, analyzing, and visualizing clinical data via standard tools/charting methods; ability to effectively present trends and distill output into actionable items for clinical team
- Demonstrated leadership or significant participation in support role for Data Management related technical, process or quality improvement initiative
- EDC experience in one or more of the following systems (OmniComm, TrialMaster, Medidata RAVE, Oracle Clinical, InForm, ClinTrial); data imports/integrations; SAS and/or SQL programming ; Data Visualization applications (JMP Clinical, Spotfire, Tableau)
- Relevant experience with CDISC SDTM
- Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
- Detailed understanding of project planning and management methods with demonstrated experience in using standard planning and communication applications (Excel, PowerPoint, MS Access, MS Project, MS Visio)
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment