Sr. Principal - Clinical Study Build Supervisor - eDC

Role Summary

Sr. Principal - Clinical Study Build Supervisor - eDC

Responsibilities

• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
• Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
• Provide insights into study level work (i.e. Data Management Plan, Project Plan, database, and observed datasets)
• Support submission, inspection and regulatory response activities
• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
• Opportunity to develop and tests new ideas and/or applies innovative solutions that add new value to the portfolio
• Increase speed, accuracy, and consistency in the development of systems solutions
• Enable metrics reporting of study development timelines and pre and postproduction changes to database
• Partner to deliver study database per business need and before first patient visit
• Follow and influence data standard decisions and strategies for a study and/or program
• Apply therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations to study build work
• Integrates multi-functional and/or external information and applies technical knowledge to data-driven decision making
• Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
• Represent Data and Analytics processes in multi-functional initiatives
• Actively engage in shared learning across the organization
• Work to Increase re-usability of forms and edits by improving the initial design
• Work to reduce postproduction changes change control process
• Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
• Interacts with regulators, business partners and outside team members on business issues
• Thinks with end to end in mind consistently managing risk to minimize impact on delivery
• Builds a diverse multi-functional and internal/external network to understand how different disciplines and approaches contribute to research and development
• Focuses on defining database solutions and timelines in support of advancing the portfolio
• The experienced Clinical Study Build Programmer ‚Äì eDC is expected to provide coaching and guidance for junior Clinical Study Build Programmers
• The Clinical Study Build Programmer ‚Äì eDC may or may not lead a team of junior Clinical Study Build Programmers
• Oversee the recruitment, development, and retention of a scientific, technical, and operationally capable workforce that is skilled and knowledgeable in end-to-end global clinical eDC system builds
• Provide effective technical leadership to an agile team of technical staff that continuously meets the needs of a changing portfolio and demonstrates judgment-based decision making, and provide leadership in clinical eDC system build delivery
• Creating a team culture that fosters inclusion and innovation and values diversity
• Responsible for effective resource planning
• Responsible for supervising clinical study build programmer staff, as assigned, including aspects of training, mentoring, goal setting, performance management, and engagement
• Ensure all necessary training is provided to staff to support job performance and knowledge

Qualifications

• Master‚Äôs degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Information Technology, Computer Sciences (or bachelor‚Äôs degree plus 3 or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors)
• Eligible to work in the United States; no sponsorship anticipated

Additional Preferences

• Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11
• Supervisory experience
• Knowledge of CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories
• Knowledge of CDISC and CDASH standards
• Ability to work independently as well as in a team
• Project and Vendor management experience
• Excellent time management and multi-project capability in a fast-paced environment
• Up-to-date on trends in the profession; quick learner of new technology
• Strong leadership, communication, and interpersonal skills
• Demonstrated teamwork and collaboration

Experience With The Following

• Articulating data flow from patient to analysis and applying this to data solutions
• Deciding technology platform for data acquisition and aggregation
• Collaborating with study team members (Data Sciences, Statistics, PK, Operations, Medical)
• Strong therapeutic/scientific knowledge; Society of Clinical Data Management certification
• Project management experience
• Familiarity with clinical data tools and technologies; data standards
• Ability to balance multiple activities, prioritize and manage ambiguity
• Demonstrated teamwork and problem-solving in a fast-paced environment

Education

• Master‚Äôs degree or equivalent in relevant field; or bachelor‚Äôs degree with substantial directly related experience

Additional Requirements

• Domestic and international travel may be required