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Regulatory and Start-Up Expert
hace 2 meses
Regulatory and Start-Up Expert
Join IQVIA Argentina as a Regulatory and Start-Up Expert and take on a challenging role in site management. As a key member of our team, you will be responsible for participating in end-to-end site management from feasibility to site closure. Your primary focus will be on serving as a point of contact for investigative sites and study team members, supporting site qualification, regulatory green light, and site maintenance/close-outs.
Key Responsibilities
- Develop in-house model process documents to ensure seamless site management.
- Act as a primary site contact for end-to-end study activity, providing detailed updates to cross-functional teams.
- Participate in study team meetings, utilizing systems and tools to track assigned activities and produce reports and metrics as needed.
- Oversee essential document collection, tracking, and review, ensuring compliance with regulatory requirements.
- Support the collection of country and site-level intelligence, facilitating informed decision-making.
- Assist with Ethics Committee and Regulatory Authority submissions, ensuring timely and accurate submissions.
- Where required, complete, manage, and/or support country and site-specific activities, such as import/export licenses, radiation board approvals, and biobank committee approvals.
Requirements
- Bachelor's Degree in Business Administration, Finance, Science, or related field, or equivalent work experience.
- Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, including experience in EC submission in the US.
- Fluent English: written and oral communication skills.
- Proficiency with Veeva Vault and Microsoft Office applications.
- Ability to negotiate complex contract and payment terms.
- Goal-oriented, self-starter with proven ability to work independently.
- Able to proactively identify issues and provide potential solutions for resolution.
- Detail-oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Good interpersonal skills.
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, improving patient outcomes and population health worldwide. Learn more at IQVIA Argentina.
