CDC Trial Manager

Location:

Athens, Attica, Greece

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Other Industries & Skills:

Legal

Job ID:

130892984

Posted On:

02 August 2024

   

Would you like to join a team that plays a crucial role in the ambitious drug development programs at Novo Nordisk? Are you a devoted clinical professional who enjoys working in a dynamic and multicultural work environment?

Then you could be our new Trial Manager Clinical Development Centre (CDC) Greece. Apply now and join us for a life-changing career!

The role is based in Athens, Greece and reports to Therapeutic Area Head of CDC.

The position

In this role, you will oversee day-to-day planning, executing, and reporting (from site feasibility up to and including study site close-out) of assigned clinical trials in CDC Greece.

The Trial Manager CDC is the single point of contact and lead in making sure that deliverables are met as per project timelines, within budget and complying with Protocol, country regulatory requirements, Helsinki Declaration, Good Clinical Practice (GCP) and Novo Nordisk Standard Operating Procedures (SOPs). Furthermore, this position will assist in the mentoring and supervision of less experienced colleagues, best practice sharing, active participation in CDC meetings and workshops, and contributes to the preparation of local guidelines/processes.

The main accountabilities will be:

-Overall trial organization and coordination within the country including assessing site selection, planning resources and budget, risk analysis and developing a strategy for trial implementation.
-Ensure compliance with the application, timely and accurate communication of trial issues and function as key point of contact for Clinical Research Associates (CRAs), Global Trial Managers (GTMs), Clinical Operations Manager (COM), Therapeutic Area Head and CDC Director.
-Ensure effective communication of all trial/project-related issues between Headquarters, CDC, the region, and other internal/external stakeholders, and collaborate with COM and CDC Feasibility Manager (FM) to ensure efficient and accurate site feasibility visits including analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies.
-Work in collaboration with Study Start-Up to organize for prompt Human Research Ethics Committee (HREC), Research Governance Office (RGO) and Therapeutic Goods Administration (TGA) approval by making timely submissions and providing responses, as requested.
-In charge of representing CDC in relevant study meetings and organizing these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings, and Study Result meetings, as well as assist in CDC TMs and be actively involved in new CDC Project Managers (PMs) onboarding and mentoring.
 

Qualifications

To be considered, you have a bachelor’s degree level in Life Science, Pharmacy or Nursing qualification, or equivalent. Fluency in English and Greek is required.

On top of what we would expect:

-Minimum 1 year of working experience as a Trial Manager (equivalent project manager role) or People Manager with tried proficiency and previous experience of successful trial and/or people management and monitoring in clinical trials in accordance with ICH GCP
-Understanding of clinical trial regulations/methodology, as well as up-to-date knowledge of the clinical trials environment (ICH GCP, regulatory issues, SOP’s) and drug development process.
-Computer literacy and IT skills utilizing SAP, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) and electronic Trial Master File (eTMF).
 

About the department

The Clinical Operations Department is a fast-growing Team with highly skilled and ambitious colleagues responsible for the planning and execution of clinical trial activities in accordance with the Product Development Plans of Novo Nordisk.

The scope of our activities is phase I to IV clinical trials and non-interventional studies in collaboration with our Headquarters and local stakeholders. Our environment is characterized by a global network with challenging assignments in a project centric organization. We focus on continuous personal and professional development and exciting opportunities which arise within or international organization.

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 63,000 employees. Together, we go further. Together, we’re life changing.

Contact

To submit your application, please upload your CV in English (click on Apply and follow the instructions). Please note that we are reviewing applications on an ongoing basis and that the position will be filled as soon as a successful candidate is found.

Deadline

Apply before 16th of August

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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