·Single point of contact for MOH and National/Independent/Site's ERB (if applicable) from start up to closure of clinical trials.
·Provide historical site activation data to enhance site selection discussions ensuring the appropriate sites are participating in the study
·Prepare and manage regulatory submissions to support clinical trials/non-interventional studies (if applicable) for both internal and external clients
·Coordinate of translation process for all the required trial documents and oversight of the quality of final documents.
·Responsible for preparing the country/Site study-level ICF as well as revising as a result of protocol amendments, risk profile updates, etc. in a timely manner.
·Interact and influence collection of required regulatory documents for investigative sites
·Drive timeliness for ERB/MOH submission for trial-level regulatory package as well as negotiate as required
·Develop and maintain relationships with MOH/ERB where applicable.
·Identify potential issues and, anticipate current trends related to regulatory/ethical issues and create plan to mitigate them.
·Ensure that required documents for importation/exportation of IP and non-IP are obtained from regulatory body as applicable.
·Ensure country level regulatory requirements within internal databases (eg. Requirements for the initiation of Trials in Affiliates)
·Maintain active relationships and/or memberships with applicable research and disease-state organizations, if applicable.
·Communicate site-level site activation updates to sites and appropriate study team members as appropriate
·Collaborate with the Clinical Research Administrator (CRA), Clinical Development Consultant (CDC), Lead SAM to declare site regulatory and site readiness for enrollment.
·Collaborate with the Clinical Research Administrator (CRA), Clinical Development Consultant (CDC), Lead SAM to manage site activity/performance during the site activation and maintenance phases of the trial
·Understand, comply, and reinforce local regulations, laws, and guidance (e.g., ICH), Medical Quality Systems (MQS) Standards and Procedures, and Good Clinical Practices (GCP)