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Site Monitor I or II, FSP - Germany/Single Sponsor

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Junior (1-2 years)
Work from: 
Germany

Offer summary

Qualifications:

Bachelor's degree or Registered Nurse (RN), Minimum 1 year of clinical monitoring experience, Experience in Oncology or high-risk therapeutic areas, Familiarity with CTMS and eTMF systems.

Key responsabilities:

  • Ensure data integrity and quality compliance
  • Monitor sites according to the Study Monitoring Plan
Parexel logo
Parexel XLarge http://www.parexel.com/
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
See more Parexel offers

Job description

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 FSP is hiring for a home-based Clinical Site Monitor I or II.

Single sponsor dedicated to a worldwide biopharmaceutical company that relentlessly seeks breakthroughs to improve patients’ lives. Their daily innovation contributes to a healthier global community. This is where today’s visionaries, solution-seekers, and trailblazers converge to shape tomorrow’s groundbreaking solutions. Together, we have the power to revolutionize patients’ well-being. Every choice and step we make is guided by our unwavering focus on patients, fostering an environment where innovation thrives.

Experience Required:

The Site Monitor will be responsible for data integrity and data quality and will ensure 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 most activities to supplement on-site visit requirements. The Site Monitor will collaborate with the Site Manager to ensure that the site follows the protocol and is inspection-ready and will coordinate with institutions and investigators at the local level.

  • A minimum of 1 year’s experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite).

  • Experience in managing complex protocols in Oncology or other therapeutic areas (TAs) where protocols are determined to be high risk:

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

  • Experience in utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence)

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Apply today!

#LI-TA1

Required profile

Experience

Level of experience: Junior (1-2 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Clinical MonitoringData IntegrityData QualityOncologyClinical Trial Management SystemsElectronic Trial Master File

Other Skills

  • Detail Oriented
  • Collaboration
  • Problem Solving
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