05 Dec
Associate Director-Senior Clinical Digital Solutions
Vacancy expired!
- Support innovation and continuous improvement of digital systems used in clinical trials.
- Leverage clinical digital solutions to achieve higher efficiencies and standards that improve cross-functional tea collaboration and coordination of operational approaches for delivering studies.
- Provide oversight for management of interactions with CROs and other digital systems vendors to ensure studies are conducted on time, of good quality, and within budget.
- Work collaboratively with Clinical Digital Solutions and IT in support of clinical and related enterprise digital solutions
- Education: Bachelor’s Degree in Engineering or Sciences preferred
- Good sound pharmaceutical industry business experience desired.
- At least 5 years of clinical digital data foundation experience with a Biotechnology/Pharmaceutical company or CRO in conducting Phase I - IV multinational clinical studies. Advanced degree in scientific, clinical research or regulatory affairs, or data foundation is desirable or equivalent by experience or technical training
- 5 plus years of cross-functional team Project Management experience. PMP or equivalent other certification e.g. LEAN Six-Sigma methodology
- Solid understanding of US and Global regulations and guidelines applicable to clinical development, inspection readiness and system validation
- Able to solve complex digital technology problems with minimal or no direct supervision
- Strong project management expertise, including designing and executing project plans, as well as communication plans associated with projects, training material development.
- Proficient, hands-on competency in utilizing tools such as Veeva CDMS or equivalent platform, g. EDC; J-Review or other data visualization tools such as Tableau desired
- Proficient in Microsoft Applications; Word, Excel, Teams, Project, Visio and PowerPoint
- Experience creating training materials is a plus
- Hands-on experience in utilizing the SharePoint platform is desirable
- Demonstrated ability to prioritize and manage multiple projects simultaneously
- Highly self-motivated, flexible, able to follow through in a fast-paced environment, and proven ability to meet key deadlines as required
- Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
- Highly proactive, flexible, curious and resilient
Vacancy expired!