Clinical Research Associate

Location:

Sofia – Sofia City, Bulgaria Provinces, Bulgaria

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Other Industries & Skills: 

Legal, Media

Job ID:

130414788

Posted On: 

01 May 2024

Are you a team player interested in clinical trial site management activities? Does dealing with people from different backgrounds excite you? Are you a highly adaptable and organized
person
who thrives in a fast-paced, dynamic work environment? If yes, then you are the Clinical Research Associate we are looking for! Join us and be part of a patient-centric global pharmaceutical company whose aim is to change patients’ lives
and apply for this exciting opportunity!

The Position

This position
provides you the opportunity to work in a high performing team while creating values for patients.
Y
ou will be the primary point of contact between site staff and Novo Nordisk.
Y
ou will be responsible for monitoring of the study at sites in compliance with local regulations, NN
SOPs
, protocol requirements and g
ood clinical practice to ensure data quality and study subject protection, as well as for recruitment at site level.
In
this role, you will deliver results that have a direct impact on the successful completion of the clinical program.
We are looking for 5 people to join our dynamic team.  A qualified candidate can be from anywhere in Bulgaria.

Your m
ain
r
esponsibilities
will be:

-Communicate with sites for ensuring adequate enrolment rate
.
Train and guide the site staff in the protocol and trial procedures
.
-Maintain and update study related documentation from CRA’s area responsibility
.
Maintain
clinical trials systems
up to date.
-Prepare and submit Monitoring Visit Reports within defined timelines
.
Perform clinical on-site monitoring activities (source data verification and review, drug accountability, data collection etc.)
.
-Identify potential risks and proactively take action to prevent or mitigate
.
Support audit and inspections at sites as applicable
-Participate in internal working groups, initiatives
and r
epresent Novo Nordisk in external working groups and at conferences
 

Qualifications

To be successful in this role you should
hold a
min. Master´s
degree
with
pharmaceutica
l/
medical
or life science focus and have
proven a
bility to work with extended
amount of documentation, and
with different types of electronic systems
.

-Willingness and ability to travel
(up to 50% across Bulgaria), you hold
valid driving license B
.
-Problem
solving
capability and ability to work in stressful situations
.
-Strong analytical skills.
-Present confident c
omputer literacy: MS Office
, experience with SOP.
-Show e
xcellent verbal and written communication skills in English and Bulgarian.
 

You have experience in independent monitoring from a similar position in the pharmaceutical industry or a Clinical Research Organization (CRO) as well as k
nowledge of GCP and local laws and regulations for clinical trials are
an advantage
. 

On a personal level, you are good at planning, coordinating and prioritizing activities in order to ensure optimal use of resources in the department, as well as good negotiation, communication
and
collaboration skills. You are able to relate to people in a diverse
and
international environment, to handle numerous tasks simultaneously.
You act as an
ambassador for NN values
. You are
adaptable person to changing environment
.

About Department

The Bulgarian affiliate is a fast growing and dynamic organization aiming to cement Novo Nordisk’s position on the market. You will also find a highly motivated and dedicated team, unique company culture as well as possibility to learn and develop. We are launching new products, making them more accessible to patients, and we are also aligned with our own long-term commitments through Changing Diabetes(R) and Changing Obesity(R).

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 energise 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

Please click on “apply now” to submit your resume in English. 

Data protection statement

Novo Nordisk will treat all personal information collected during the recruitment process with the utmost confidentiality and in line with current data protection legislation. We rely on the lawful basis of Art. 6 (1) (b) of the GDPR to process the information provided by you in the recruitment process. For more information on how we collect, process and use the data you have provided, please see our privacy notice for job applicants which is available on
novonordisk.bg/recruitment-notice.html

Should you be successful in your application, the information provided, and further information which will be gathered at the relevant time, will be subsequently used for the administration of your employment and in relation to any legal challenge which may be made regarding our recruitment practices.

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.

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