Study Start‑Up Manager

Clinical Operations | Regulatory & Site Activation

Location: Flexible / office‑based depending on project needs
Travel: Occasional travel may be required

Contract Length: 3- 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 Study 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 Study 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 ResponsibilitiesLead and oversee site activation and maintenance activities, including pre‑award and bid defence supportDevelop and maintain Regulatory & Start‑Up Management Plans in line with project scope, timelines, and strategyDefine and implement regulatory strategy, including submission requirements and authorisation pathwaysReview, negotiate, and track regulatory and contractual documentation to ensure full executionMonitor site performance metrics and ensure compliance with SOPs, GCP, ICH, and applicable regulationsCollaborate across regions and countries to deliver multi‑regional and multi‑protocol programmesAssess regulatory complexity and provide creative, practical solutions to operational challengesMaintain accurate data in internal systems (including CTMS) and project tracking toolsMentor and coach team members and provide regulatory leadership and guidanceBuild and maintain strong relationships with sponsors, investigative sites, and key customersDeliver presentations or training to clients and colleagues where requiredSupport monthly study budget planning and reviews, as neededAbout You

You are a confident study start up 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 fieldTypically 3–5 years’ relevant experience, with broader experience (up to 7+ years) in a scientific or clinical research environment preferredDemonstrated experience working on international clinical trialsIn‑depth knowledge of the clinical trial lifecycle, regulatory requirements, and drug development processStrong understanding of GCP, ICH, and global regulatory guidelinesExcellent negotiation, communication, and interpersonal skillsProven ability to lead through influence and deliver results across cross‑functional teamsStrong organisational, planning, and problem‑solving skillsConfidence using clinical systems and technology (e.g. CTMS)The ability to work proactively, exercise sound judgement, and manage competing prioritiesWhy 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.

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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 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.

The potential base pay range for this role, when annualized, is zł195,700.00 - zł363,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.