Local Clinical Study Manager (Belgium/ Denmark/ Netherlands/ Sweden)

IQVIA; Basel; Hybrid; CHF 120,000 - 180,000; Full time

Job summary

IQVIA is seeking a Local Clinical Study Manager for a sponsor-dedicated Clinical FSP. The role is full-time and home-based, with possible locations in Belgium, Denmark, Netherlands, or Sweden.

You will oversee operational and scientific aspects, including trial setup, execution, and delivery at the local level, collaborating with regulatory, QA, and clinical teams. Responsibilities include leading cross-functional teams, monitoring progress, managing sites and vendors, and ensuring ICH-GCP

Qualifications

• Bachelor degree in life sciences or related discipline.
• 5+ years in clinical research with at least 2 years in project management.
• Solid knowledge of ICH GCP and local regulations.
• Proven ability to lead cross-functional teams to deliver trials on time and on budget.
• Experience in Oncology or Onco-hematology is required.
• Excellent spoken and written English and local language.

Responsibilities

• Provide overall leadership and oversight for trial delivery, quality, timelines and outcomes.
• Lead cross-functional teams, set priorities, and ensure effective communication.
• Plan and oversee monitoring activities, provide status updates and drive progress.
• Manage vendors and budgets, coordinate resources to support study objectives.
• Drive site activation and startup activities with regulatory and in-house teams.
• Ensure regulatory compliance and trial master file quality, risk mitigation and issue resolution.

Skills

Cross-functional leadership

Project management

English language proficiency

Stakeholder management

Education

Bachelor's in life sciences

Tools

CTMS

Job description

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.

We currently offer the exciting opportunity to join the team as a Local Clinical Study Manager in full-time and home-based setting. The position can be located in Belgium or Denmark or Netherlands or Sweden. In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of your assigned clinical trials at the local level.

MAIN RESPONSIBILITIES

• Provides overall clinical study leadership and oversight for trial delivery, execution, quality, timelines, and outcomes.
• Leads and manages cross-functional clinical teams, setting priorities, expectations, and ensuring effective communication.
• Plans and oversees daily study monitoring activities, providing status updates and driving study progress.
• Manages vendors and budgets (when applicable) and coordinates resources to support study objectives.
• Drives site activation and startup activities, collaborating with regulatory, startup, and in-house teams.
• Monitors study quality and compliance, identifying risks, implementing mitigation plans, and addressing issues proactively.
• Reviews and approves monitoring reports, ensuring timely follow-up and resolution of site-related findings.
• Develops and delivers study-specific training and supports ongoing development of clinical staff and CRAs.
• Analyzes study metrics and trends, using data to improve execution, consistency, and quality across countries and regions.
• Ensures regulatory compliance, including submissions, approvals, renewals, reporting requirements, and adherence to ICH-GCP and local regulations.
• Oversees Trial Master File (eTMF) quality, ensuring essential documents are complete and compliant.
• Partners with Quality Assurance (QA) on audits, CAPA activities, and inspection readiness.
• Acts as the primary point of contact for clinical monitoring issues, coordinating communication across stakeholders and vendors.
• Facilitates proactive problem-solving and escalation management across cross-functional teams.
• Maintains project plans, tools, systems, and reporting to ensure accurate project tracking and visibility.

REQUIRED SKILLS AND QUALIFICATIONS

• Bachelor degree in related discipline, preferably in life science
• Five or more years of experience in clinical research, including a minimum of 2 years' project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
• Good knowledge of international guidelines ICH GCP as well as relevant local regulations
• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
• Previous work experience in TA's: Oncology or Onco-hematology is required
• Good knowledge of the Drug Development Process
• Excellent knowledge of spoken and written English and local language.
• Good ability to learn and to adapt to work with IT systems.
• Effective decision-making is crucial for resolving challenges and ensuring alignment with overall study goals.
• Experience in monitoring study activities for compliance and inspection readiness.
• Strong interpersonal skills are vital for collaborating with internal teams, stakeholders, and external vendors.
• A deep understanding of clinical operations processes, including trial data collection and management, is paramount to ensuring successful study execution.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

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.