Clinical Site Lead (remote)
Novo NordiskAbout the role
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 healthcare 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
Contributes to the successful execution of clinical trials through driving the performance of clinical trial sites with cross-functional coordination and communication for assigned trials. Supports process improvement and innovation projects.
Relationships
Reports to a Senior Manager level (or above). Builds relationships with internal stakeholders relevant to the planning and execution of clinical trials (e.g., across US Operations, US Clinical, Medical & Regulatory Affairs (CMR), HQ Research & Development (R&D). Builds relationships with external partners relevant to the planning and execution of clinical trials (e.g., clinical sites, health care/research networks, vendors, etc.).
Essential Functions
- Oversees clinical site performance and ensures consistency in site management for assigned trials by providing support and guidance to CRAs and In-House CRAs, including review of monitoring visit reports, site metrics, and data trends to ensure quality and compliance
- Coordinates and drives site start-up/activation activities, including the deployment of Site Selection Visit (SSV)/Site Initiation Visit (SIV) training tools and materials
- Drives US monitoring activities in accordance with the Monitoring Plan as well as Risk-Based Quality Management (RBQM) principles including coordination of deliverables for database lock (DBL) and site/trial closure
- Supports internal audits and health authority inspections in collaboration with the Trial Manager, including inspection readiness activities and the development of corrective/preventative action plans
- Develops trial-level site communications inclusive of key updates and information
Physical Requirements
20-30% overnight travel required.
Qualifications
- Bachelor’s degree or Registered Nurse (RN) degree/diploma required
- Minimum of 6 years’ experience in the planning, and conduct of GCP clinical trials, including at least 4 years of direct site management and logistical clinical trial execution in the pharmaceutical industry (Pharma/Biotech/CRO) required
- On-site monitoring experience preferred
- Strong understanding of International Council for Harmonisation Good Clinical Practice (ICH-GCP) principles and the application of those principles to trial planning and execution 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
The base compensation range for this position is $99,600 - 184,200. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or 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 ti
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