Novo Nordisk Hiring M Pharm For Team Lead Clinical Transparency Position
Novo Nordisk Hiring Team Lead Clinical Transparency for M Pharm at Bangalore. Interested Candidates can check out the details below and Apply Online
Job Role: Team Lead Clinical Transparency
Job Category: Clinical Development and Medical
Job Location: Bangalore, Karnataka, IN
Department – Clinical Reporting
Role:
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.
Responsibilities:
- Responsible to Perform Clinical Transparency deliverables and People Management.
- Ensure effective coaching and mentoring of team members to enhance performance and sup-port 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.
Qualification
- PhD, MSc., M Pharm, MD, BDS, or equivalent.
- 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
Deadline: 11th, Aug 2023
Novo Nordisk Hiring M Pharm For Team Lead Clinical Transparency Position. Here are five Possible interview questions along with their possible answers :
1. Question: Can you describe your experience in handling Clinical Transparency deliverables, including protocol registration and results disclosure of clinical trials?
Answer: Certainly. Over the past 5 years, I have been actively involved in handling Clinical Transparency tasks in the pharmaceutical industry. My responsibilities included the preparation, review, and timely submission of clinical trial protocols and results to various registries like clinicaltrials.gov, EudraCT, and German Synopsis. I have a strong understanding of global regulatory requirements and policies related to clinical trial disclosure and transparency, which allows me to ensure compliance and adherence to best practices.
2. Question: As a Team Lead, how do you plan to support and develop your team members to enhance their performance and individual growth?
Answer: As a Team Lead, I believe in effective coaching and mentoring to foster a positive and high-performing team. I will invest time in understanding each team member’s strengths and areas for improvement, and tailor coaching strategies accordingly. Regular feedback sessions and setting clear performance goals will be essential for their development. Additionally, I will provide opportunities for skill-building through workshops and training to equip them with the necessary knowledge and expertise.
3. Question: Could you share an example of a process improvement or efficiency initiative you implemented in your previous role related to clinical trial disclosure and registration activities?
Answer: One of the process improvements I implemented in my previous role was streamlining the documentation and submission process for clinical trial results disclosure. By creating standardized templates and establishing clear timelines for submission, we were able to improve efficiency significantly. This not only ensured timely compliance with disclosure requirements but also reduced the administrative burden on the team, allowing them to focus on more strategic tasks.
4. Question: How do you plan to ensure effective collaboration with stakeholders and colleagues globally to meet the Clinical Transparency goals?
Answer: Effective collaboration is crucial for achieving Clinical Transparency goals. I would initiate regular virtual meetings and establish communication channels to keep all stakeholders informed about ongoing projects, milestones, and potential challenges. Active engagement with cross-functional teams would ensure alignment with broader organizational objectives. By fostering an open and transparent communication culture, we can foster a sense of teamwork and collective responsibility towards achieving our goals.
5. Question: In your experience, how have you demonstrated your ability to identify better practices and create improvements in clinical trial methodology?
Answer: In my previous role, I conducted regular process reviews to identify areas where clinical trial methodology could be enhanced. For instance, we analyzed data collection processes and identified opportunities to incorporate electronic data capture (EDC) systems, which significantly improved data accuracy and reduced data entry time. Additionally, I actively participated in industry conferences and workshops, which exposed me to new methodologies and technologies. I believe in fostering a culture of continuous learning and improvement, and I am always eager to explore and implement better practices in clinical trial processes.
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