CDC Trial Manager

Do you wish to be part of an international clinical trial team as we set out on a journey into new and exciting therapeutic areas and ways of working? Can you help us bring new treatments to patients, faster and smarter, by leading and optimizing trial work within your area of expertise? Then, apply now for a life-changing career!

The position

As a CDC Trial Manager you will manage daily the allocated trials on Clinical Development Centre (CDC) Czech Republic Therapy Area (TA) level to deliver the TA trials KPIs. You will be responsible for project planning, management, and execution from site selection to post clinical trial activities. You will develop and execute specific TA trial delivery strategy, including trial-specific risk management plan. You will manage the relevant Trial Project Teams including CRAs and CTAs, that support assigned clinical trials. You will act as the main point of contact for internal and external stakeholders on TA-specific trial strategic discussions and decisions in CDC.

You will establish and maintain the professional relationships with internal and external stakeholders. You will participate in regular meetings with CDC Trial Team members to monitor the progress of the plan’s implementation, conduct regular meetings with CRAs to discuss the progress of recruitment plans, trial squad meetings and represent CDC/country Therapy Area in study meetings. Contribute to and participate in Local Investigator Meetings to support trial implementation. Organise pre-audit meetings with CRAs, develop the audit activities plan with timelines and follow up on implementation.

Other responsibilities will include:

• Deliverables on assigned clinical trials within the CDC including strategy recruitment, retention, risk analysis and management, database lock (DBL) and archiving, and responsible for achieving deliverables within agreed timelines and quality measures.
• Support in develop the trial Risk Management Plan and if necessary, escalate identified issues/challenges to appropriate stakeholders, country and CDC recruitment plans with trigger points and ensure continuous monitoring of progression, taking necessary measures to mitigate potential delays.
• Responsibility for budgets, timeline, quality, and risk in the start-up phase of the trial, proactively identifying any risks in start-up and site activation plans and developing and implementing mitigation strategies as required. Create and review trial country budgets. Approve trial related payments.
• Provide operational and therapeutic expertise to the project and provide Global Teams with local intelligence. Provide input for the annual report. Review and approve all type of site visit reports. Oversee the set-up of internal clinical systems, oversight, and compliance check of e-TMF for assigned clinical trials in close collaboration with CDC CTA and track site trainings through CRA responsible.
• Control the accuracy of the trial data based on DM reports in the systems and follow up with CRAs towards DBL. Review of documents for CTR in close collaboration with CTA. Supervise archiving of trials in close collaboration with CTA. Perform TM Monitoring, co-visits with CRAs, monthly COSMOS quality checks on site and country level and follow-up with CRAs accordingly.

Qualifications

• Master’s degree in life/natural science or similar.
• Minimum 3 years of experience in operational aspects of planning and conducting of clinical trials. Preferably 1 year of experience in project management of clinical trials.
• Fluent in Czech and English – oral and written.
• Understanding of clinical trial regulations in the Czech Republic. Excellent knowledge of clinical trial methodology. Up to date knowledge of the clinical trials environment. Therapeutic knowledge as applicable, demonstrated understanding of diseases and treatments. Knowledge of drug development process.
• Good communication skills, innovative mindset, organizational skills, prioritization, troubleshooting skills, collaboration skills, negotiation skills, influencing,
• Adaptability to a changing work environment.
• Anticipating/foreseeing difficulties and taking preventive actions.
• Assessing problems as they arise and making quick decisions on appropriate actions.
• Valid driving licence B
• Project and resource management skills and ability to deliver quality in a timely manner.
• Computer literacy and IT skills.
• Proven success in managing clinical trials (desirable), including multi-centre studies.

About Department

CDC (Clinical Development Center) Czech Republic is part of Region South-East Europe, Middle East and Africa (SEEMEA) and is a new set up of clinical organization in Novo Nordisk. Within CDC, you will join Therapy Area unit specialized in CVD (Cardiovascular Disease), OSCD (Other serious chronic diseases) & Rare Diseases. 

Working at Novo Nordisk

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 the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Contact

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

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.