Clinical Research Associate

Are you highly motivated by being able to make a difference in improving
patients' lives? Are you a high-performing professional who can energize
people around you? If yes, then continue reading and apply now!
In Novo Nordisk Saudi Arabia, the position of Clinical Research Associate
(CRA) provides you the opportunity to work in a high-performing team to
contribute directly towards the business results while creating value for
patients.

The position will be based in Riyadh, Saudi Arabia, and report to the Clinical
Operation Manager.

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 that the conduct of the trial follows the
currently approved protocol, GCP, and local legislation.
Being the main point of contact between site staff and Novo Nordisk, you will
act as an ambassador for the company and contribute to making Novo Nordisk the
preferred partner as well as establishing and maintaining a professional
relationship with all KOL, internal, and external stakeholders.
You will be responsible for supporting Site Management activities which
includes feasibility, selection, initiation, routine monitoring in compliance
with local regulations, ICH-GCP, Novo Nordisk procedures, and protocol
requirements to ensure data quality and study subject protection.
In addition to above, you will communicate with sites for ensuring an adequate
enrolment rate, train and guide the site staff in the protocol and trial
procedures as well as perform source data verification and review, drug
accountability, data collection, etc., as a part of clinical on-site
monitoring activities.
Your responsibilities will also include the following:

• Prepare and submit site visit Reports within defined timelines


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


• Participate in internal working groups, and 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 license.
We expect you to have:
* Academic Degree in Life Science or similar disciplines
* At least ‎1 year 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, and 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.

About the department
At the 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 a 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 Clinical Development Centre in Turkey.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We 're
inspired by life in all its forms and shapes, ups and downs, opportunities,
and challenges. For employees at Novo Nordisk, life means many things - from
the building blocks of life that form the basis of ground-breaking scientific
research to our rich personal lives that motivate and energize us to perform
our best at work. Ultimately, life is why we're all here - to ensure that
people can lead a life independent of chronic disease.

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 April ‎10, ‎2023.

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.