**Regulatory & Start‑Up Manager** **Clinical Operations | Regulatory & Site Activation** **Location:** Flexible / office‑based depending on project needs **Travel:** Occasional travel may be required **Contract Length** : 4- 6 months Are you an experienced **Regulatory & Start‑Up professional** looking to lead complex clinical trial start‑up activities across global or multi‑regional studies? We are seeking a **Regulatory & Start‑Up Manager** to take ownership of site activation, regulatory strategy, and ongoing site maintenance for high‑profile clinical research programmes. This is a key role within Clinical Operations, providing leadership, oversight, and subject‑matter expertise to ensure studies are delivered compliantly, efficiently, and on time. **The Role** As Regulatory & Start‑Up Manager, you will **direct and manage all site activation and regulatory activities** for assigned studies or multi‑protocol programmes. You will act as a central point of contact for investigative sites, sponsors, and internal stakeholders, ensuring regulatory and contractual requirements are met throughout start‑up and maintenance phases. You will also contribute to **business development and pre‑award activities** , providing regulatory insight and solutions to support successful bids and study delivery. **Key Responsibilities** + Lead and oversee **site activation and maintenance activities** , including pre‑award and bid defence support + Develop and maintain **Regulatory & Start‑Up Management Plans** in line with project scope, timelines, and strategy + Define and implement **regulatory strategy** , including submission requirements and authorisation pathways + Review, negotiate, and track **regulatory and contractual documentation** to ensure full execution + Monitor site performance metrics and ensure compliance with SOPs, GCP, ICH, and applicable regulations + Collaborate across regions and countries to deliver multi‑regional and multi‑protocol programmes + Assess regulatory complexity and provide **creative, practical solutions** to operational challenges + Maintain accurate data in internal systems (including **CTMS** ) and project tracking tools + Mentor and coach team members and provide regulatory leadership and guidance + Build and maintain strong relationships with sponsors, investigative sites, and key customers + Deliver presentations or training to clients and colleagues where required + Support monthly study budget planning and reviews, as needed **About You** You are a confident regulatory leader with strong stakeholder management skills and the ability to balance multiple, complex priorities. **You will bring:** + A **Bachelor’s degree in Life Sciences** or a related field + Typically **3–5 years’ relevant experience** , with broader experience (up to 7+ years) in a scientific or clinical research environment preferred + Demonstrated experience working on **international clinical trials** + In‑depth knowledge of the **clinical trial lifecycle** , regulatory requirements, and drug development process + Strong understanding of **GCP, ICH** , and global regulatory guidelines + Excellent negotiation, communication, and interpersonal skills + Proven ability to lead through influence and deliver results across cross‑functional teams + Strong organisational, planning, and problem‑solving skills + Confidence using clinical systems and technology (e.g. CTMS) + The ability to work proactively, exercise sound judgement, and manage competing priorities **Why Join Us?** You’ll play a pivotal role in bringing innovative therapies to patients, working on complex global studies within a collaborative and supportive environment. This role offers the opportunity to **lead, influence, and grow** within a highly respected clinical research organisation. \#LI-HCPN \#LI-CES \#LI-DNP \#LI-CT1 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled