Site Monitor - Poland - FSP - Oncology

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.

Do you know why we are one of only three CROs to have received the Leadership Award for 11 consecutive years? Because we appreciate our team, whose dedication and commitment to excellence is reflected in this award, and we work with heart, keeping the patient at the center of everything we do.

Join our team and develop your career with us by contributing your personal and professional talents and skills. Together we will continue to do things that matter to people.

Parexel FSP is looking for Site Monitor I in Poland to strengthen our clinical operations team. Work from home and with the flexibility you want. Our monitors have less travel and less workload to maintain work-life balance. We offer long-term projects, world-class technology and training tailored to your individual experience.

As a Site Monitor, will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (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, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).

You will have the opportunity to be a unique sponsor dedicated to one of the top 10 pharmaceutical companies in the world, working on oncology studies that deliver real impact.

You will possess:

• Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.
• A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite).
• Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence).
• Experience in managing complex protocols in Oncology or other therapeutic areas (TA’s) where protocols are determined to be high risk.
• Proficiency in local language is required.
• English proficiency is required.
• Ability to manage required travel of up to 75% on a regular basis.
• Current driver’s license required.

Send me your updated resume to marta.kuniewicz@parexel.com for an immediate interview.