Manager - Trial Management

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 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 Trial Management (TM) 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.

Relationships

Reports to a Senior Manager (or above) within North America Clinical Development (NACD).

Manages mutually beneficial relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g., 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 NACD, CMR, International Operations (IO), HQ R&D, & Commercial).

Essential Functions

• Drives the objective setting, prioritization & tracking within Trial Management & for indirect reports
• 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 NACD by assuring training plans (NACD level & project level) are developed & deployed within a staff subset of NACD & for indirect reports
• Cross-functional leadership of assigned clinical trials within North America
• Provides operational direction to the trial team according to agreed strategy and plan, optimizing speed, quality and budget in compliance with standard processes, policies and procedures
• Collaborates with Clinical Finance & Operations to ensure the NACD trial budget is developed and managed in line with organizational expectations
• Leads the activities relating to the execution of the Audit Management Plan for assigned studies
• Responsible for health authority (eg, FDA) inspection preparedness and execution

Physical Requirements

10-20% overnight travel required; May be required to work company holidays and weekends.

Qualifications

• Bachelor’s degree required. An advanced degree is preferred
• A minimum of 8 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 6 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)
• Previous experience leading cross-function clinical trial operations teams preferred
• Expert in 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

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, 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.