05 Dec
Associate Director-Senior Clinical Digital Solutions
New Jersey, Bridgewater , 08807 Bridgewater USA

Vacancy expired!

Description:The Senior Clinical Digital Solutions - Associate Director primarily supports digital projects and products that are used by Clinical Operations.The candidate is expected to have broad business systems knowledge and experience in supporting clinical Electronic Data Capture (EDC), SAS, CTMS and other tools used in clinical data sciences planning, oversight and execution of complex global studies across multiple phases of oncology clinical trials (phases I-III).As a subject matter expert (SME) for Clinical Digital Solutions, this role includes four primary accountabilities:
  • 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

Minimum Requirements:
  • Education: Bachelor’s Degree in Engineering or Sciences preferred
  • Good sound pharmaceutical industry business experience desired.

Experience:
  • 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.

Additional Skills/Competencies:
  • 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!


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