Associate Start Up & Regulatory Manager
Job Summary
Associate Regulatory & StartUp Manager
Clinical Operations Regulatory & Site Activation
Location: Flexible / officebased depending on project needs
Travel: Occasional travel may be required
Contract Length: 4-6 months
Are you looking to take the next step in your Regulatory & StartUp career within clinical research We are seeking an Associate Regulatory & StartUp Manager to support and deliver site activation regulatory and maintenance activities across clinical studies working closely with crossfunctional teams and global stakeholders.
This role offers the opportunity to build leadership capability contribute to complex international studies and play a critical role in bringing new therapies to patients.
The Role
As an Associate Regulatory & StartUp Manager you will support the delivery of site activation and maintenance activities for assigned studies or multiprotocol programmes. You will help ensure regulatory submissions contracts and essential documents are managed compliantly and efficiently while developing your leadership and project management experience.
You will work as part of the study management team contributing regulatory expertise throughout study startup and maintenance phases.
Key Responsibilities
- Support the execution of site activation and maintenance activities including preaward and bid defence activities
- Assist in developing and maintaining Regulatory & StartUp Management Plans aligned to project scope and timelines
- Contribute to defining regulatory strategy submission pathways and authorisation requirements
- Prepare review and track regulatory and contractual documentation ensuring timely execution
- Identify regulatory challenges and support the development of practical solutions
- Monitor site performance metrics and support compliance with SOPs GCP ICH and applicable regulations
- Collaborate with regional country and global teams to deliver study milestones
- Maintain accurate records within CTMS databases timelines and tracking tools
- Support Quality Management activities to ensure appropriate standards are maintained
- Provide input into client communications presentations or training where required
- Support budget planning and study tracking activities as needed
- Actively develop leadership skills including mentoring or supporting junior colleagues
About You
You are a motivated regulatory professional with a solid foundation in clinical research and a desire to grow your responsibilities and impact.
You will bring:
- A Bachelors degree in a related scientific or clinical field
- Typically 23 years relevant experience in clinical research
- Around 3 years clinical research experience including exposure to leadership or coordination responsibilities
- Good knowledge of clinical research processes medical terminology and regulations
- Experience working with clinical systems and strong Microsoft Office skills
- Strong communication organisational and interpersonal skills
- The ability to manage multiple tasks and priorities with attention to detail
- Confidence working both independently and collaboratively
- A proactive solutionfocused mindset with the ability to build strong working relationships
What We Offer
This is an excellent opportunity for someone looking to step into greater responsibility within Regulatory & StartUp gain exposure to global studies and develop leadership capability within a supportive and collaborative clinical research environment.
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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
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.
Required Experience:
Manager
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more