Location: Lexington, MA
Company: Novo Nordisk
to regulatory requirements and industry-standards. Trial Data Management delivers high quality data for further analysis and reporting and work with stakeholders across many functions, both within and outside Development and we are an essential part of clinical drug development in Novo Nordisk.
In Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction and life cycle management. 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 report to the Vice
Presidents (VP) of Trial Data Management and be a member of the Trial Data Management VP leadership team. You will be overall responsible for managing and leading a team of highly engaged data managers and will be overall responsible for the data management deliverables within the Boston Global Development area.
You will be responsible for motivating and securing competency development of the team members. Ensuring quality in the work, continuous improvements of the team and process development will be essential in the job. You will also be responsible for the department budget and you will work in close collaboration with the managers for the other Trial Data Management teams and with
our stakeholders. It is important that you are capable of challenging and improving current processes and are embracing new methods and working styles.
Through empowerment you are utilising the full potential of the employees in both the department and Trial Data Management as an area. Please also note that applications for this position will be reviewed after the December holidays. Preliminary interviews are currently targeted to be conducted in the middle/end of January Relationships Reports to Vice President of Trial Data Management. Essential Functions Manage the Trial Data Management Boston Global Development team according to the Novo Nordisk Way including developing the employees and the team to meet Novo Nordisk’ business needs Is part of the management team in Trial Data Management and will be responsible for driving and executing on the local department strategic goals as set forth by their executive line management Help ensure a continuous improvement mind-set by participating in quality activities, feedback sessions and lessons learned Develop and execute Strategy for own area as well as influence functional strategy Anticipate new challenges and needs for the department and develop the processes in the organization accordingly, as well as ensure continuous improvement Responsible for the performance of the employees in collaboration with the VP of Trial Data Management, and compliance with ISO, SOPs and regulatory guidelines.
This has a direct impact on the critical time used for getting new drugs to the market and the quality of the work performed The holder of the position is empowered to make decisions that facilitate the execution of daily tasks in the team. The decisions taken will be in accordance with Novo Nordisk SOPs, Novo Nordisk essentials and Novo Nordisk Way The holder of the position acts independently and is responsible for mentoring, coaching and developing the employees in the team Communication is a very important element of this job, as is the ability to work in a global environment Host and contribute to share best practice discussions in the department Follow-up and maintain team line budget Responsible for resource allocation, ensuring that trials are supplied with Data Managers in a timely manner Aim at embracing new methods and working style Physical Requirements Up to 10% overnight travel required.
Development of People Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications Bachelors degree required, Masters degree or Ph D in Life Science or related discipline highly preferred Minimum of 12 years of experience working with clinical development with Bachelors; Advanced degree (Masters or Ph D) with 10 yrs working with clinical development can also be considered Strong knowledge of the medical industry Experience in leadership and management positions with a proven track record of managing cross-functional and international teams In-depth understanding of computer systems and information technology Familiarity with data structures in CTMS, EDC, CDMS, and/or data warehouse systems Regular experience in communication and delivering presentations.
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. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, interaction, gender identity, interactionual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at -xyz X. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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