Clinical Team Leader

4 days ago


กรงเทพมหานคร, Thailand Novo Nordisk Full time

**About the Department**

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.

Headquartered in Denmark, Novo Nordisk employs over 43,500 people in 80 countries, and markets its products in more than 170 countries.

Novo Nordisk in Thailand has been working closely with the stakeholders for more than 30 years. Our purpose in Thailand is to defeat diabetes, obesity, and other serious chronic diseases, as it is globally. Novo Nordisk Thailand certified as the “Best Place To Work in Thailand in 2020 and 2021”.

**The Position**

Clinical Team Leader in partnership with the Clinical Operations Manager (the COM), will coordinate for the clinical trial set-up to ensure the appropriate site and resources allocation as well as oversee the local clinical projects to be executed in timely and effective manner within budget and comply with the regulatory requirements. Apart from that, this role will lead in providing the clinical trial communications/insight to the internal and external stakeholders.

This position will report to Clinical Operations Manager

In this role, you will perform the following tasks:

- Develop CRAs and implement necessary actions to improve their performance - Ensures high performance and efficiency of the clinical team through co-monitoring/accompanied site visits and ongoing mentoring of CRA team, ensures defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management, and contributes to the risk management plan and coordinates clinical issue escalation and resolution with the Clinical Operations Manager and the CDC-Project Manager.
- Supervise quality clinical trial projects (CDP and/or local) in the country - Works collaboratively with CDC-PM to coordinate the execution of clinical deliverables and study timelines by setting up clinical tools and processes for the study team, track tasks performed by CRAs ensuring timely and effective execution of local clinical trials, and ensure that budgets are managed in line with the plan and together with CDC-PM update the study budget if required.
- Coordinate the clinical trial set-up in partnership with the COM - Coordinate for the country level protocol feasibility aligned with the COM, work collaboration with COM in effective site recruitment, providing the necessary criteria for successful staffing, assist CRA in the preparation and carry out of pre-study and/or during study conduct, and negotiate Clinical Trial Agreements with local investigators and monitor the relevant payments
- Provide the clinical trial related communication and insight to the key internal and external stakeholders - Provide key operational information to the COM and regularly update on the clinical trial progress, elaborate the related reports, and maintain ongoing communication with Ethics Committees and the Health Authority, ensuring the Central and local (as applicable) Ethics Committee is provided with the documents requested.

**Qualifications**
- Bachelor’s Degree or Higher in Pharmacy or related fields
- Preferably 5 - 7 years’ experience in conducting clinical trials as CRA
- Minimum of 2 years’ experience in supervising clinical trials as a clinical team lead or similar roles
- Strong knowledge in regulatory requirement as well as standard operating procedures (SOP)
- Good command of English in both written and spoken, and fluency in Thai

**Working at Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales - we’re all working to move the needle on patient care.

**Contact**

**Deadline**

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.

LI-AMS1


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