Regulatory and Start up Manager
Responsible for coordinating the operational and strategic aspects for Clinical Trial Submissions
Essential Functions:
- Lead the submission process from strategy formation to clinical trial approval
- Coordinate creation of trial submissions strategy development, planning and delivery
- Responsible for Quality checks on CTIS before submissions
- Financial planning an tracking
- Driving discussions, consolidates inputs from stakeholders and facilitate CTR submission strategy
- Responsible for Coordinating submissions in the CTIS portal
Qualifications
- 3 to 5 years experience building RDC databases in support of clinical research
- Experience in regulatory and submissions
- Project management skills
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at [click to reveal website link]
The potential base pay range for this role, when annualized, is zł146,800.00 - zł363,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.