Job Description

Job Responsibilities:

• 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.

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 https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.