Feasibility: plan the robust and data driven feasibility function so that site selection can be data driven.
Study Start-Up (SSU): plan the robust SSU strategy from the CDC so that overall allocated study can be started within very competitive timeline.
Quality and Training; Drive the pro-active quality and training strategy to assure audit and inspection readiness and boost the GCP and compliance mindset.
Qualifications
Bachelor’s degree or higher qualification in Pharmacy, Life Sciences, or another related field.
Minimum of 7+ years of experience in the clinical operations area and 4-5 years of experience in people management.
Experience in GCP audits and inspections is highly preferred with a solid knowledge of clinical trial processes and protocols. Awareness on LEAN principal and methodology of other operational excellence framework will have added advantage.
Knowledgeable in ICH-GCP, local requirements, and Novo Nordisk’s Standard Operating Procedures (SOPs). You must also be able to adapt to changes and manage the unit and clinical trials in control of the innovative use of new IT systems.
Strong functional and cross functional stakeholders’ management and situation leadership. You have highly proficient verbal and written communication skills with the ability to manage complex projects with strong planning, problem-solving, and organizational skills.
