Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Team Lead Clinical Transparency
Job Description
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.
Job Description
• 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.
Candidate Profile
• 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
Additional Information
Qualification : PhD, MSc., M.Pharm, MD, BDS
Experience : 5 years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical
End Date : 31st July, 2023
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