Job Description
Prepares and/or reviews regulatory documents to support clinical trial submissions. With guidance from senior staff, provides regulatory support for more complex projects.
Acts as a Clinical Trial Regulatory Manager (CTRM) on straightforward projects independently and complex regulatory projects under the guidance of senior staff.
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
May strategically plan and perform/support European centralized submissions and facilitate global submissions with minimal supervision.
Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
Ensures high quality in all regulatory deliverables
Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
Ability to participate in audits relating to Projects and Systems.
May perform additional tasks as deemed appropriate by Line Manager
Required Qualifications
Bachelor's Degree Degree in Lifescience or related discipline
At least 1-2 years relevant experience with EU CTIS, Global core pack knowledge
Experience in country oversight particularly for amendments
Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
Strong software and computer skills, including Microsoft Office, CTMS, SA WF, SAFE, Wingspan, as applicable;
Possesses a specific regulatory or technical expertise;
Good, solid interpersonal communication (oral and written) and organisation skills;
Ability to establish and maintain effective working relationships with coworkers, managers and clients;
Demonstrates self-motivation and enthusiasm;
Ability to work on several projects, with direction from senior staff as appropriate;
Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
Ability to make decisions on discrete tasks under senior supervision.
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.
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