Site Monitor - Hungary - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is currently seeking Site Monitors I/II in Hungary.

You would be dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases.

Our sponsor has a long history of excellence in research, delivering medicines, vaccines, and other health solutions for some of the most difficult diseases in the world.

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level.

Key Accountabilities

• Ensuring regulatory, ICH-GCP and protocol compliance.

• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.

• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes.

• Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations.

• Conducts source document review and verification of appropriate site source documents and medical records.

• Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete.

• Manages reporting of protocol deviations and appropriate follow up.

• Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.

• Conducts follow up for escalated adverse event monitoring (AEM) report queries.

• Collaborates with primary Site Manager who will act as the primary liaison with site personnel.

The Individual

• A minimum of 1 year experience as a clinical monitor with demonstrated experience of onsite monitoring.

• Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.

• Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show agility to work with new systems to support monitoring practice.

• Fluency in local language.

• Advanced level or fluency in English is required.

Who are Parexel?

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

Here are a few requirements specific to this advertised role.

Skills

• Networking and relationship building skills. Ability to communicate effectively and appropriately with internal and external stakeholders.

• Ability to adapt to changing technologies and processes. Effectively overcoming barriers encountered during the implementation of new processes and systems.

• Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization.

• Identifies and builds effective relationships with investigator site staff and other stakeholders.

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