Clinical Site Lead @ Novo Nordisk - Plainsboro, NJ

Job Overview

4 months ago

Clinical Site Lead

Novo Nordisk - Plainsboro, NJ

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

Responsible for operational aspects of managing clinical site performance through coordination and communication with In-House Clinical Research Associates (CRAs), Field Based CRAs and the Trial Manager (TM) for assigned trials, within the Trial Management (TM) function of North America Clinical Operations (NACO). 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. 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 Operations (NACO). Contribute to mutually beneficial relationships with external partners relevant to the planning & execution of clinical trial improvement/innovation projects for NACO & 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 NACO & Novo Nordisk (e.g., across NACO, 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 NACO, 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

  • 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

  • Identifies/escalates any risks to trial delivery and contributes to mitigation development and deployment

  • Develops regional site communication including key updates and information

  • Active coaching, mentorship and contribution to training of NACO staff to build insight and talent


Physical Requirements

20-30% overnight travel required; May be required to work company holidays and weekends. The incumbent can work remotely from anywhere in the United States. Novo Nordisk requires all new hires, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine prior to the first date of employment. 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

  • Bachelor’s degree required; relevant Novo Nordisk 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


In compliance with Colorado’s Equal Pay for Equal Work Act, see compensation and benefits below:


The base compensation range for this position is $91,103 to $167,733. Base compensation is determined based on a number of factors. In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and other Company factors.


Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its uncapped sick time policy, flex-able vacation policy, and parental leave policy.

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.

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