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

IQVIA; Belgique; Remote; EUR 90,000 - 130,000; Full time

Job summary

IQVIA sponsor-dedicated Clinical Functional Service Partnerships team is seeking a Local Clinical Study Manager to lead and oversee trials across therapeutic areas. The role is full-time and home-based, with location options Belgium/Denmark/Netherlands/Sweden.

You will drive study delivery, manage cross-functional teams, monitor progress, ensure regulatory compliance, and maintain TMF quality, while coordinating with vendors and sites to achieve timelines and quality, in line with ICH-GCP.

Qualifications

• Five or more years in clinical research with at least 2 years in project management.
• Knowledge of international guidelines ICH GCP and local regulations.
• Ability to lead cross-functional teams and drive trial delivery to timelines.

Responsibilities

• Provides overall clinical study leadership and oversight for trial delivery, quality, timelines and outcomes.
• Leads cross-functional teams, sets priorities, and ensures effective communication.
• Plans and oversees daily study monitoring activities and status updates.
• Manages vendors and budgets, and coordinates resources to support study objectives.
• Drives site activation and startup activities with regulatory, startup and in-house teams.
• Monitors quality and compliance, identifies risks, and implements mitigation plans.
• Reviews monitoring reports and ensures timely follow-up of findings.
• Develops training for study staff and supports CRA development.
• Analyzes study metrics and trends to improve execution across regions.
• Ensures regulatory compliance, TMF quality, and inspection readiness.

Skills

Clinical research

Project management

Cross-functional leadership

ICH-GCP knowledge

Vendor management

Education

Bachelor degree in life science

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.*