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Manager - Site Management

Facility:  Clinical Development and Medical
Location: 

Plainsboro, NJ, US

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions, and developing and implementing regulatory strategies with the Food & Drug Administration (FDA), to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

Provides tactical leadership to staff within the Site Management (SM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Leads & delivers upon improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals &/or future aspirations. Provides leadership in continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology, and with change management skills. Ensures business needs are met through alignment of business plans and operational need and by efficiencies and optimization of resource allocation. Responsibility for quality and performance related to managing clinical trial sites, document handling and trial product handling.

 

Relationships

Reports to a Senior Manager (or above) within NACO. Manages mutually beneficial relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g., vendors, Health Systems, Contract Research Organizations & Site Management Organizations etc.). Manages relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g., across NACO, CMR, International Operations (IO), HQ R&D, & Commercial). Supervisory responsibilities for direct reports (>2).

 

Essential Functions

  • Drives the objective setting, prioritization & tracking within the function & for direct/indirect reports; provides relevant input and guidance to other areas within NACO
  • Ensures alignment & support is in place to plan & deliver all relevant services/tasks in support of the design, planning & quality delivery of clinical trials (including required staffing, training & processes)
  • Develops & manages relevant budgets – including compiling, forecasting, tracking & revising
  • Trains, develops & engages staff as required across NACO by assuring training plans (NACO level & project level) are developed & deployed within the function & for direct/indirect reports
  • Demonstrates technical expertise within responsibility areas, staying up-to-date of new practices and building knowledge of emerging trends and advances within area

 

Physical Requirements

10-20% overnight travel required; May require occasional work outside of standard business hours to support special requests/events.

Novo Nordisk requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by November 15, 2021. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.

 

Qualifications

  • A Bachelor’s degree is required.  An advanced degree is preferred
  • A minimum of 7 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 2 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)
  • Expert in International Conference on Harmonisation (ICH)-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials
  • In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning & conduct of GCP clinical trials
  • Excellent communications skills (verbal, written, presentation) in English
  • Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management
  • A minimum of 3 years’ experience in peer-to-peer coaching/mentoring is required
  • Demonstrated collaborative and stakeholder management skills

 

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. 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, sex, gender identity, sexual 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.