Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage site activation and regulatory activities for clinical studies, ensuring compliance and project timelines.
- Company: IQVIA is a global leader in clinical research services, enhancing healthcare through innovative solutions.
- Benefits: Enjoy flexible work options, professional development opportunities, and a collaborative team environment.
- Why this job: Join a dynamic team making a real impact on patient outcomes and gain valuable leadership experience.
- Qualifications: Bachelor's degree and 3 years of clinical research experience, including leadership roles.
- Other info: Opportunity to mentor colleagues and develop relationships with key clients.
The predicted salary is between 36000 - 60000 £ per year.
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Essential Functions
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
- Mentor and coach colleagues as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
- May take a lead role in developing long standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues and professional bodies, as required.
- May be involved in activities related to monthly study budget planning and reviews.
Qualifications
- Bachelor's Degree Related field Req
- 3 years clinical research experience, including 1 year experience in a leadership capacity.
- Equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Broad knowledge of clinical research.
Associate Regulatory and Start Up Manager employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Regulatory and Start Up Manager
✨Tip Number 1
Familiarise yourself with the regulatory landscape relevant to clinical trials. Understanding the specific regulations and guidelines that govern site activation and maintenance will give you an edge in discussions and interviews.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who have experience in regulatory roles. Attend industry conferences or webinars to make connections and gain insights into best practices that can enhance your application.
✨Tip Number 3
Prepare to discuss your leadership experiences in clinical research during interviews. Be ready to share specific examples of how you've managed projects, resolved issues, and collaborated with teams to meet regulatory requirements.
✨Tip Number 4
Stay updated on the latest trends and technologies in clinical research. Being knowledgeable about new tools and methodologies can demonstrate your commitment to the field and your ability to contribute to innovative solutions at StudySmarter.
We think you need these skills to ace Associate Regulatory and Start Up Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Associate Regulatory and Start Up Manager position. Understand the essential functions and qualifications required, so you can tailor your application accordingly.
Tailor Your CV: Highlight relevant experience in clinical research and leadership roles in your CV. Use specific examples that demonstrate your ability to manage site activation and regulatory activities, as well as your knowledge of clinical systems and procedures.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the responsibilities outlined in the job description. Emphasise your experience with regulatory strategy, project management, and collaboration across teams, showcasing how you can contribute to the company's goals.
Proofread and Edit: Before submitting your application, carefully proofread your CV and cover letter. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail and professionalism.
How to prepare for a job interview at IQVIA
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory requirements and challenges in clinical research. Being able to discuss recent changes or trends will demonstrate your expertise and show that you are proactive in staying informed.
✨Showcase Leadership Experience
Highlight your previous leadership roles and how you've successfully managed teams or projects. Be prepared to share specific examples of how you resolved issues or improved processes, as this will illustrate your capability to lead in a similar role.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask how you would handle specific regulatory challenges or site activation scenarios. Practising your responses will help you articulate your thought process and problem-solving skills effectively during the interview.
✨Demonstrate Collaboration Skills
Since the role requires collaboration across various teams, be ready to discuss how you've worked with different departments or stakeholders in the past. Providing examples of successful teamwork will highlight your ability to communicate and work well with others.
