Manager - Clinical Programming
RESOLVIT
Bringing Solutions That Make Business Better
We are seeking a Manager - Clinical Programming to be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.
As the Manager - Clinical Programming, you will act as an expert representing the department or programming function on departmental initiatives, providing input and influencing groups outside of your own discipline. You will be internally and/or externally recognized as a technical expert in your area of specialism and apply this expertise effectively. You will also negotiate strategy and issues at internal regulatory meetings. Additionally, you will:
- Effectively explain concepts at all levels in the organization, including to senior managers and stakeholders
- Define, develop, and embed standards/best practices within a function in accordance with internal and industry standards
- Represent programming at external discussions of technical concepts and use of standards to advance technical capability across the industry
What You’ll Need to be Successful:
- Bachelor’s, Master’s, or PhD or equivalent with extensive (and in-depth) practical experience or proven experience at the expert level
- Experience in line management of staff
- Experience leading teams and business improvement efforts with positive results
- Solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11)
- Demonstrated knowledge of and experience with the application of CDISC data and standards, primarily the creation and use of ADaM datasets
Great Additional Skills:
- Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change
- Broad understanding of external landscape with respect to role and its related functions (Clinical Data Interchange Standards Consortium (CDISC), cancer Biomedical Informatics Grid (caBIG), outsourcing strategies)
- Experience applying creative thinking/business analysis skills to improve or solve business problems
- Demonstrated effectiveness in building, managing, and leveraging networks/client relationships internally
- Ability to manage conflicting demands and priorities and to negotiate successfully
- Project management or relevant experience
- Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. working with CROs and academic institutions)