Clinical Data Specialist

The Role:

The Clinical Data Specialist will manage service providers' activities in overseeing the data management process for phase I-IV clinical trials, as well as ensuring that the data from the trials conforms to the Principia's standards. The incumbent will also develop systems for organizing data to review, identify and report trends to ensure the integrity of complex clinical data.

Essential Responsibilities

• Leads the development of eCRFs and database development and testing specifications by interacting with other functional area representative and ensuring Principia data standards are followed appropriately
• Responsible for the implementation of standards within a study across multiple service providers and data sources (e.g., EDC, IRT, Labs, etc.)
• Oversee vendors that have been contracted to handle Principia's data and ensure the data are complete, accurate and delivered within the timelines agreed to
• Ensure data transfer specifications are in place and review data transfers for consistency with Principia data standards and SDTM specifications
• Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.
• Responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals
• Ensures all data from the trial data sources are complete, accurate and coded correctly
• Develops and executes ad hoc database queries utilizing data review and query tools
• Maintain Principia data standards library
• Troubleshoot configuration problems in the Rave EDC system being used for a study
• Report lags in data entry and query resolution to ensure timeliness of database lock
• Ensure all data collected from the clinical studies are stored appropriately in Principia's data repository
• Report query trends and data entry/query metrics and oversee suggest any changes or intervention as appropriate
• Prioritize projects and coordinate data management activities in support of corporate goals and objectives
• Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices
• Address the business needs of CDM functional customers
• Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership.

Qualifications

• Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies

• Working knowledge of CDISC and SDTM nomenclature

• Working knowledge of SAS databases and SAS programming

• Multi-task in a fast-paced environment

• Work without close supervision both independently and as part of a team

• Proactively foresee and solve problems and commit to a high level of service

• Build strong cooperative relationships with coworkers

• Work well with people from a variety of different backgrounds and cultures

• Write complex documentation without direct supervision

• Possess a high degree of attention to detail

• Propose solutions and schedule all problem-solving activities under indirect supervision in clear project plan with defined goals, decisions, and endpoints

• Previous employment at a pharmaceutical or biotech company or CRO

Education

• BA or BS degree with a minimum of 3 years relevant experience in a life science industry; or equivalent combination of education andexperience.

• Working knowledge of CDISC standards

Language skills:

• Superior written and spoken communication skills in English

• Ability to clearly communicate complex issues, observations and resolutions to management

Reasoning ability:

• Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions

• Work on complex problems where the analysis of situations or data requires in-depth evaluation

• Ability to understand interrelationships of data and the logical aspects of datasets

• May determine methods and procedures on new assignments