IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. By creating intelligent connections, IQVIA accelerates the development and commercialization of innovative medical treatments. Their mission is to improve patient outcomes and global population health through cutting-edge solutions.
With a presence in over 100 countries, IQVIA is at the forefront of providing high-quality clinical research, data analytics, and technology solutions to healthcare organizations, pharmaceutical companies, and medical device manufacturers. Headquartered in Durham, North Carolina, IQVIA’s expertise in clinical trials, data analytics, and regulatory affairs plays a critical role in shaping the future of healthcare.
Responsibilities of the Clinical Operations – Regulatory & Start-Up Specialist
The Regulatory & Start-Up Specialist at IQVIA plays a pivotal role in executing key activities during the clinical trials process. This includes the feasibility, site identification, regulatory documentation, start-up, and maintenance tasks, all in compliance with local and international regulations, SOPs, and project requirements. Here’s an overview of the key responsibilities:
- Site Activation and Feasibility: The Specialist will be the primary point of contact for investigative sites. They are responsible for conducting feasibility assessments, assisting with site activation, and ensuring the necessary documentation is completed and accurate. This includes reviewing and negotiating site documents and contracts with sites and sponsors.
- Document Management: The role involves preparing, reviewing, and distributing site-related documentation such as Informed Consent Forms (ICFs), regulatory documents, ethics approvals, and investigator packs. It’s crucial to track the progress and execution of all required documents.
- Project Coordination and Tracking: You will work closely with the Site Activation Manager (SAM) and Project Management team to ensure timelines are adhered to. Regular updates will be provided on the progress of document approvals, ensuring full execution of contracts.
- Compliance & Oversight: The Specialist is responsible for maintaining adherence to applicable regulations and SOPs. This role demands ensuring all regulatory requirements are met while keeping internal systems and tracking tools updated.
Required Qualifications for the Role
To be considered for the Regulatory & Start-Up Specialist position at IQVIA, candidates must meet the following qualifications:
- Educational Background: A Bachelor’s Degree in Life Sciences or a related field is required.
- Experience: A minimum of 1-3 years of experience in clinical research or a related healthcare field is required. Relevant experience in a clinical or healthcare environment will be considered a valuable asset.
- Additional Skills: Candidates with experience in clinical trials, regulatory documentation, or site activation will have an advantage.
Skills and Competencies Required
To excel in the Regulatory & Start-Up Specialist role, candidates should possess the following skills:
- Attention to Detail: Precision is crucial when preparing and reviewing site documents, ensuring accuracy and consistency.
- Project Management: Strong organizational skills to track multiple activities, timelines, and deliverables.
- Communication Skills: Ability to negotiate and communicate effectively with investigative sites, sponsors, and internal teams.
- Knowledge of Clinical Regulations: Understanding of clinical trial regulations, ethics approval processes, and contractual requirements is essential.
- Problem-Solving Abilities: Ability to resolve issues related to site activation and document completion.
