Job Responsibilities:
- Support country SSU strategy to meet timelines, ensure adherence to SOPs, WIs, and quality standards. Act as Single Point of Contact (SPOC) for assigned studies to ensure SSU timelines and deliverables are met
- Perform regulatory, start-up, and maintenance activities per regulations and company procedures.
- Manage investigator payments, including setup, execution, and tracking, ensuring compliance with contracts, approvals, and timelines.
- Support in oversee project budget planning, financial tracking, and reporting; contribute to contract and budget development.
- Review, prepare, and negotiate site contracts and budgets (If applicable); ensure contracts are executed and deliverables completed.
- Maintain and update systems, databases, and project tracking tools.
- Executes and monitors internal controls; Translates Grant Plans into local Payment Schemes; Prepares and submits country TCF(s)
- Contribute to regulatory intelligence, pre-award activities, importation support, and sponsor communication if required.
- Mentor and train less experienced staff; participate in feasibility, site identification, and selection visits 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