Team Lead Clinical Transparency role Novo Nordisk – APPLY NOW
Role : Team Lead Clinical Transparency
Category : Clinical Development and Medical
Location : Bangalore, Karnataka, IN
Department : Clinical Reporting
Qualification : PhD, MSc., M Pharm, MD, BDS, or equivalent.
The Position
- As a Team Lead – Clinical Transparency, you lead and drive deliverables ensuring Novo Nordisk compliance with Disclosure Requirements.
- Manage the teams to meet the department and organization’s business goals.
- You will perform Clinical Transparency tasks including preparation/review and timely submission of protocol registration and results disclosure of clinical trials to different registries example clinicaltrials.gov, EudraCT, German Synopsis and other clinical trial disclosure and transparency related deliverables.
- Contribute to ongoing process improvements and efficiency initiatives in disclosure and registration activities internally, in cross-functional areas and globally.
Key responsibilities:
- Responsible to Perform Clinical Transparency deliverables and People Management.
- Ensure effective coaching and mentoring of team members to enhance performance and support individual development.
- Plan resources for all deliverables from the team and support manager in ensuring optimal and flexible use of resources.
- Ensure effective collaboration with stakeholders and colleagues globally.
- Ensure continuous improvement and processes are efficient, scalable, and effective.
- Maintain up-to-date knowledge on global regulatory requirements and other policies related to clinical trial disclosure and transparency.
Experience :
- Above 5 years of experience of evaluation and communication of data preferably from the pharmaceutical /CRO industry.
- Experience with clinical drug development, GCP and relevant regulatory requirements in relation to clinical trials registration and transparency, especially the EudraCT and CT.gov related requirements.
- Experience in leadership is preferred including people and project management roles
- Experience with clinical trial methodology.
- Excellent understanding of clinical development and regulatory processes and requirements.
- Excellent communication and presentation skills
- Good mentoring and training skills.
- Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc
To submit your application, please upload your CV and motivational letter online
Deadline : 11th, Aug 2023
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Here are some interview questions and possible answers for the role of Team Lead Clinical Transparency:
- Question: Can you explain your understanding of Clinical Transparency and its significance in the pharmaceutical industry?
Answer: Clinical Transparency refers to the disclosure of clinical trial data and results to the public, regulatory authorities, and other stakeholders. It ensures that clinical trial information is made accessible to promote transparency, scientific advancement, and patient safety. As a Team Lead Clinical Transparency, my role would involve overseeing the preparation, review, and timely submission of clinical trial data to various registries, such as clinicaltrials.gov and EudraCT, to comply with disclosure requirements. This facilitates data sharing, fosters trust with the public, and aligns with Novo Nordisk’s commitment to ethical and responsible clinical development.
- Question: How would you approach managing and mentoring your team members to enhance their performance and support individual development?
Answer: As a Team Lead, my approach to managing and mentoring the team would involve fostering a supportive and collaborative work environment. I would encourage open communication and provide regular feedback to help team members identify areas for improvement and leverage their strengths. Additionally, I would promote skill development through training programs and offer coaching to address any challenges they may face. Recognizing individual achievements and contributions will also be crucial in motivating the team and boosting morale.
- Question: How do you stay updated on global regulatory requirements and policies related to clinical trial disclosure and transparency?
Answer: Staying updated on global regulatory requirements is essential for maintaining compliance and ensuring best practices. I regularly attend industry conferences, webinars, and workshops related to clinical transparency and regulatory affairs. I subscribe to newsletters and follow reputable sources and regulatory agencies’ websites to keep abreast of any updates or changes in disclosure guidelines. Additionally, I engage in discussions with colleagues and participate in cross-functional forums to share knowledge and insights on evolving regulatory requirements.
- Question: Can you provide an example of a challenging situation you faced in your previous role related to clinical trial disclosure and transparency and how you handled it?
Answer: In my previous role, we encountered a situation where there was a delay in submitting clinical trial results to a regulatory agency due to data discrepancies. To address this challenge, I immediately assembled a cross-functional team to investigate the root cause of the discrepancies and ensure data accuracy. We collaborated closely with the clinical development team, statisticians, and data managers to rectify the issues promptly. I also communicated transparently with the regulatory agency, informing them of the delay and the steps being taken to resolve it. By demonstrating proactive communication and corrective actions, we successfully mitigated the impact of the delay and ensured compliance with the disclosure requirements.
- Question: How would you promote process improvements and efficiency initiatives in disclosure and registration activities within your team and globally?
Answer: To promote process improvements and efficiency initiatives, I would adopt a data-driven approach. First, I would analyze the current disclosure and registration processes to identify bottlenecks and areas for optimization. I would encourage team members to share their insights and ideas for improvement. Collaborating with cross-functional teams and stakeholders would be essential to gain a comprehensive understanding of the challenges and potential solutions. Implementing automation tools and technologies where feasible could also enhance efficiency. Moreover, I would benchmark best practices in the industry and seek opportunities to align our processes with global standards to achieve scalability and effectiveness.
Good luck with your interview !
