Clinical Research Associate

Are you a dedicated clinical trial professional with a direct site management
experience? Are you highly motivated by being able to make a difference to
improving patients' lives? If yes, keep reading - this role might be just for
you!

The position will be based in Riyadh and reporting to the Clinical Operation
Manager.

About the department

At Clinical, Medical and Quality (CMQ) Department, we aim to improve patients
' lives by being a leading strategic partner in the generation, interpretation
& communication of scientific data with relevant stakeholders, while ensuring
full compliance in all our internal and external activities.
We work closely with cross-functional team to support Novo Nordisk KSA
business growth needs in a continuously changing environment. All CMQ
activities are built on our strengths in business understanding, strategic
thinking, creativity and innovation.
The Clinical Operations Team is responsible for conducting high quality
clinical trials in Saudi Arabia within several therapy areas and is working
closely with Russia CDC organization.

The Position

As Clinical Research Associate your role is to verify the accuracy and
completeness of the trial data, that the rights and well-being of human
subjects are protected, and the conduct of the trial follows the current
approved protocol, GCP and local legislations.

Being the main point of contact between site staff and Novo Nordisk, you will
act as ambassador for the company and contribute to making Novo Nordisk the
preferred partner as well as establishing and maintaining the professional
relationship with all KOL, internal and external stakeholders.

You will be responsible for supporting Site Management with the feasibility,
selection, and initiation of sites as well as conducting and closing
activities of the appointed studies in compliance with local regulations, ICH-
GCP, Novo Nordisk procedures and protocol requirements to ensure data quality
and study subject protection.

Adding to the above, you will communicate with sites for ensuring adequate
enrolment rate, and you will train and guide the site staff in the protocol
and trial procedures as well as performing clinical on-site monitoring
activities (source data verification and review, drug accountability, data
collection etc.).

Your responsibilities will also include the following:

• Prepare and submit Monitoring Visit Reports within defined timelines


• Maintain and update study related documentation from CRA's area responsibility


• Participate in internal working groups, initiatives and represent Novo Nordisk in external working groups and at conferences


• Assisting with audits and inspections at sites and in the affiliate


• Excellence in off-site and on-site management activities including elements of Risk Based Monitoring.

Qualifications

In order to be considered, you need to be fluent in both English and Arabic
and have a valid driving licence.
We expect you to have:
* Academic Degree in Life Science or similar disciplines
* At least ‎2 years of experience in direct site monitoring and performing all types of visits
* Experience in taking ownership of start-up activities to ensure timely FPFV, coordinating and driving start-up activities in assigned trials, providing insightful input on local study start-up strategy and regulatory submissions documents and timelines
* Ability to build and maintain strong relationships and successfully cooperate with internal and external stakeholders including KOLs
* Knowledge of ICH GCP, regulatory issues and SOPs

In addition to the above, travel will be required including some overnight
stays depending on the clinical site's location.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and
balancing what is important at different stages of our career is never easy.
That 's why we make room for diverse life situations, always putting people
first. We value our employees for the unique skills they bring to the table,
and we work continuously to bring out the best in them. Working at Novo
Nordisk is working toward something bigger than ourselves, and it's a
collective effort. Novo Nordisk relies on the joint potential and
collaboration of its more than ‎40,000 employees. Together, we go further.
Together, we're life changing.

Contact

If you believe you are qualified, and are willing to take the challenge,
please send your CV directly via our online application tool.
We thank all applicants for their interest, however, only those candidates
selected for interviews will be contacted.

Deadline

Apply before ‎15 September ‎2022.

We commit to an inclusive recruitment process and equality of opportunity for
all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be
the best company in the world. We need to aspire to be the best company for
the world and we know that this is only possible with talented employees with
diverse perspectives, backgrounds and cultures. We are therefore committed to
creating an inclusive culture that celebrates the diversity of our employees,
the patients we serve and communities we operate in. Together, we 're life
changing.