• Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned. Distribute and collect CDAs for potential study sites.

• Provide country-specific study start-up expertise to study start-up team leads and project teams. Create study start-up document templates.

• Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies.

• Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs.

• Review and translate drug labels.

• Perform independent quality review of submission packages.

• Responsible for the translation and coordination of translations for documents required for submission.

• Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.

• Copy and route incoming correspondence, internal documentation, etc, as appropriate.

• Responsible for the timely follow-up for queries made by EC/competent authority (CA).

• Coordinate and create documents and material needed to support SIV

• Responsible for the collection of critical documents required for IP release.

• Responsible for the dispatch, negotiation, execution, and tracking of contract with sites and other sites, as appropriate.

• Responsible for the timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS in assigned countries.

• Attend study team meetings as required, including Kick-Off Meeting.

• Responsible for the collection and maintenance of the current regulatory/CA and EC submission information and similar information for other related organizations in the assigned countries and update relevant information system.

• To be familiar with ICH GCP, relevant country regulations/guidelines, and SOPs.

• Competent in communication and influencing skills to ensure timely follow up, issue resolution, and report updates, as outlined in the communication and escalation plan with timely documentation.

• Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable.

• Develop and maintain effective relationships with local, regional, and country authorities.

• Comply with all department requirements regarding information provision and status updating and reporting.

• To undertake other reasonably related duties as may be assigned from time to time e.g. protocol amendment submissions, Investigator site budget negotiation, if required.

Job Requirements:

• Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

• In-depth knowledge of clinical systems, procedures, and corporate standards.

• Good negotiating and communication skills with ability to challenge, if applicable.

• Effective communication, organizational, and interpersonal skills.

• Ability to work independently and to effectively prioritize tasks.

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.

• Understanding of regulated clinical trial environment and knowledge of drug development process.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.