Regulatory Specialist II
hace 7 días
As a Regulatory & Start Up Specialist II at IQVIA Argentina, you will play a critical role in ensuring the successful execution of site activation activities in accordance with local and international regulations, standard operating procedures, and project requirements.
Key Responsibilities- Serve as the Single Point of Contact (SPOC) for investigative sites, Site Activation Manager, Project Management team, and other departments, ensuring adherence to standard operating procedures, quality of designated deliverables, and project timelines.
- Perform start-up and site activation activities, distributing completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish, and agree on project planning and project timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- Bachelor's Degree in life sciences or a related field.
- 2 years clinical research experience: regulatory, submissions, regulatory entities, is a plus: 1 year experience in a leadership capacity.
- Fluent English (conversational).
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with the ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- 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 the regulated clinical trial environment and knowledge of the drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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