Manager of Centralised Monitoring Unit in global clinical development
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Søborg
- Clinical Development and Medical
- Søborg
Are you looking for the next step in your career heading up a team with responsibilities for Centralised Monitoring Unit deliverables? Do you want to take part in our new trial management journey? And are you a visionary leader, motivated by a high level of responsibility combined with people management and global scientific collaborations? Then you might be our next colleague to join the Centralised Monitoring Unit in Novo Nordisk Headquarters.
The ideal candidate has demonstrated experience in driving and sustaining implementation of risk-based study execution and centralized monitoring activities to ensure compliance with regulatory requirements and drive process efficiencies.
About the department
The Centralised Monitoring Unit (CMU) in Novo Nordisk headquarters (HQ) is a department in the Trial Operations Centre of Expertise anchored in Trial Portfolio Management and Innovation (TPM&I) in Global Development. We work closely with all other skill areas in Global Development, e.g. Trial Management, Data Management, Clinical Pharmacology, Biostatistics, Clinical Reporting, Medical & Science as well as with our Global Development Global Business Services (GD GBS) in India, and our global Clinical, Medical & Regulatory (CMR) organisation.
The CMU enables decision making in clinical trial conduct across the global clinical trial portfolio. Key deliverables from the HQ CMU are statistical monitoring, development of reports for centralised monitoring and process facilitation to enable regulatory compliance and drive optimal implementation of risk-based study execution across the global NN organisation.
Overall the TPM&I area consists of approximately 150 highly skilled people based in Denmark and India, responsible for providing strategic leadership in the areas of Medical & Science, Trial Operations, Global Trial Effectiveness, Vendor Management, Process Improvements and Digital Transformation. In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product launch. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics.
The position
You will in the role as Manager for the CMU HQ unit have a combined people management role as well as an operational leadership role being responsible for an evolving area with increased focus on the importance of centralized oversight of Novo Nordisk’s monitoring activities across clinical development programs. Your line management responsibility will include heading up a team of 4 Specialists driving our HQ based Clinical Data Surveillance and Risk Based Monitoring activities.
Your key responsibilities include:
- Line management of the HQ CMU specialists including performance management and competency development by coaching and guiding your team members and setting expectations and ambitious goals, ensuring the success of the team
- Cross-functional leadership and partnership across the business and IT for Risk Based Study Execution and Clinical Risk Management (CRM) capabilities.
- Setting clear expectations and giving appropriate guidance on ‘what good looks like’ for CMU roles to drive transformation within clinical development in HQ and across the global organization through the CMR’s
- Clinical system ownership with responsibility for the development, implementation, and maintenance of the clinical system strategy for CRM
- Engaging with internal and external partners on new operating models, capabilities, and technologies
- Being overall responsible for collaborating with Process Anchors and CMR Leadership in the development of CRM system strategies and plans and working with IT Leadership and potentially Third-Party Organizations to drive plan implementation
- Developing, implementing and maintaining systems and process automation strategy for CRM
Qualifications
You hold a master’s degree or bachelor’s degree in Natural Science or similar and have several years of experience working with clinical drug development. You have previous experience with line management and preferably experience with project management. Furthermore, it is expected that you have experience with the operational aspects of planning and conducting global clinical trials and CRM/Risk Based Monitoring.
You are familiar with cross-organisational and global collaborations representing trial management and you understand and can work and navigate well in a project-driven matrix organisation.
It is expected that you can inspire and motivate employees to do their best while having an organised and structured approach to leading employees. Preferably you have previous experience and can navigate well during organisational transformations.
You must be fluent in English, have a proactive mind-set and ability to work independently in a continuously developing environment. You possess proven strong analytical skills, and you excel in tutoring and data presentation. You are well organised, a strong communicator, and have solid problem-solving capabilities. You can keep your spirits high even when under pressure, and you can collaborate at any organisational level.
Working at Novo Nordisk
At Novo Nordisk, we are the world leader in diabetes care and a major player in obesity treatment, haemostasis management, growth hormone therapy and hormone replacement therapy. Our R&D and production facilities span five continents and our people are united by their passion for creating sustainable solutions. Our success is built on more than 90 years of innovation and commitment to patient-care. We combine world-class scientific, pharmaceutical, and clinical expertise with the highest ethical standards to continue to improve the quality of life of millions of patients across the world.
Contact
For further information, please contact Bo Maach-Møller +45 3079 5437.
Deadline
17 May 2020.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 1.5.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- Søborg
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