Regulatory and Start Up Manager - Bulgaria
$48,840–$73,260 year
On-site · Sofia, Sofia-Capital, Bulgaria
Job Summary
Direct and manage site activation and regulatory activities for selected studies or multi-protocol programs, including pre-award activities; oversee site activation and maintenance; develop and implement the Management Plan within the Scope of Work and Project Plan; provide regulatory and technical scientific support to enable study initiation, maintenance, and compliant business development; mentor and coach colleagues; ensure quality standards (CTMS and related systems) are maintained; may lead development of long-standing relationships with IQVIA customers; participate in budget planning and client training.
Required Qualifications
- Bachelor's Degree Life sciences
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role
- Strong negotiation and communication skills
- Good regulatory and/or technical writing skills
- Good knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
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