Address
Form of workAbout 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
Responsible for operational aspects of managing Clinical Site performance through coordination and communication with CSSAs, CRAs and the Trial Manager (TM) for assigned trials, within the Therapy Area T of North America Clinical Development (NACD).
Delivers upon improvement/innovation projects for the department (subset) of NACD and/or as part of a global team and as aligned to a business case, goals &/or future aspirations. Contribute to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology.
Relationships
Reports to a Manager (or above) within North America Clinical Development (NADO). Contribute to mutually beneficial relationships with external partners relevant to the planning & execution of clinical trial improvement/innovation projects for NACD & Novo Nordisk (e.g., Health Systems, Contract Research Organizations & Site Management Organizations etc.).
Contribute to relationships positively with internal stakeholders relevant to the planning and execution of clinical trial improvement/innovation projects for NACD & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ R&D, & Commercial).
Essential Functions
- Oversees site performance for the lifecycle of assigned trials (e.g., start-up, recruitment, retention, quality, data entry, etc.), including tracking of trends and reporting of key metrics
- In collaboration with the Trial Manager, support, prepare for and follow-up on audits & inspections
- Share information, collaborate and provide relevant input and guidance to other areas within NACD, CMR and global partners
- Demonstrate technical expertise within responsibility areas, stay up-to-date on new practices and build knowledge of emerging trends and advances within area
- Coordinates and drives site selection & start-up/activation activities including Site Selection Visit (SSV)/Site Initiation Visit (SIV) training tools and materials development
- Drive monitoring activities during maintenance and ensures coordination of deliverables for DBL and trial closure
- Lead Trial CORE Team Meetings and other relevant teams
- Reviews and approves monitoring visit reports for assigned sites
- Accountable for ensuring that any issues are escalated as appropriate to the Trial Manager and/or relevant stakeholders
- Identifies/escalates any risks to trial delivery and contributes to mitigation development and deployment
- Develops trial-level communication including key updates and information
- Active coaching, mentorship and contribution to training of NACD staff to build insight and talent
Physical Requirements
20-30% overnight travel required.
Qualifications
- Bachelor’s degree required; relevant industry experience may be substituted in lieu of degree where appropriate
- A minimum of 6 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 4 years of direct site management and logistical clinical trial execution required in the pharmaceutical industry (Pharma/Biotech/CRO) required
- On-site monitoring experience preferred
- Expert in ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials required
- In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning & conduct of GCP clinical trials required
- Excellent communications skills (verbal, written, presentation) in English
- Demonstrated collaborative and stakeholder management skills
- Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management
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.
