Clinical Research Manager
hace 1 semana
Clinical Research Manager
**Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO-
**The Position**
- As Clinical Research Manager you will manage and coordinate the implementation of local clinical projects, ensuring that are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice), Novo Nordisk Standard Operating Procedures and local policies. You will also be responsible of the coordination, supervision, and development of CRAs (Clinical Research Associate) to ensure high performance and development of the Clinical Research Associate team.**Activities and Responsibilities**
- Lead quality clinical trial projects in the country.
- Provide trial related communication and insight to key internal and external stakeholders.
- Develop Clinical Research Associates and implement necessary actions to improve their performance.
- Coordinate the clinical trial set up in partnership with Clinical, Medical, Regulatory & Quality Director.
- Perform monitoring visits to support the Clinical Trials running process.
**Required Qualifications**
- University Degree or higher qualification in Pharmacy, Chemist, Pharmaceutical Engineer, Biologist, Medical Doctor or similar, other compatible with the health care sector. Fluent in oral and written English level.
- Minimum 5 years of experience in clinical research, with solid understanding of clinical trial design, trial execution and operations. Experience with clinical trial budget management and forecasting.
- Minimum 2 years of people management experience with strong leadership skills.
- Stakeholder management and Project Management skills. Ability to work effectively in a cross-functional team environment.
- Strong knowledge of applicable regulations, standards, and guidelines (e.g., ICH-GCP, FDA regulations).
- Proficiency in Microsoft Office and clinical trial management systems (e.g., CTMS).
**Desired Qualifications**
- Master’s degree or advanced degree in Healthcare related areas.
- Experience with FCPA (Foreign Corrupt Practices Act).
**About the Department**
- Novo Nordisk was stablished as an affiliate over a decade ago, and ever since we arrived in Colombia, we have not ceased our commitment to thousands of citizens living with non-communicable diseases throughout the country. We offer an innovative portfolio for treating diabetes, obesity, growth, and bleeding disorders; and most importantly: We offer an opportunity to change their lives.- Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key challenges? Are you seeking for a globally ranked Great Place to Work® company to work for? Are you in the market for a diverse and inclusive workplace? Then we might have the right position for you. We are looking for our next Clinical Research Manager to join our team, if you are a team player and would like to take part of a true-life changing career start with us here at Novo Nordisk. Make sure to check this out**Working at Novo Nordisk**
- Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world, and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.**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.
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