Job Overview
The Project Director will oversee the management and oversight of study and regional/country level activities from study startup through conduct and study close.
* Manage study start up process in countries assigned and/or oversee CRO responsible for these activities as applicable.
* Identify and evaluate sites to ensure they can meet all study protocol requirements.
* Collaborate with accountable roles to identify and manage deviations and risks in study startup and execution.
* Leader of the Local Study Team, ensuring compliance to relevant Global and Local, internal and external requirements and regulations.
* Provide timely communication bidirectionally between the global and local study team.
Responsibilities
The Project Director will be responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close.
* May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee CRO responsible for these activities as applicable.
* Site identification and feasibility ensuring countries/sites can meet all study protocol requirements.
* Provides country level input on Startup and Recruitment milestones as provided by CRO and/or Country Trial Manager to Global Study Manager during planning.
Requirements:
* Relevant operational clinical trial experience.
* A scientific or technical degree is preferred along with knowledge of clinical trial methodology.
* 3~5+ years of relevant experience in BS/BSc/MS/MSc.
* Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility.
* English is required.