Clinical Site & Start-up Associate

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

Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio.

 

Contributes to local or increasingly complex 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 and/or future aspirations.

 

Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools, and technology.

 

Relationships

Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials improvement/innovation projects for NACD and Novo Nordisk (e.g., clinical trial site staff, IRBs, clinical research vendors).

 

Manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical trials improvement/innovation projects for NACD and Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ R&D and Commercial).

 

Provides excellent customer service and builds strong working relationships with investigative sites and internal/external partners.

 

Essential Functions

• Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials in line with established targets and including communication of updates
• Ensures proactive risk identification and mitigation planning for assigned clinical trial sites
• Drives and tracks site activation and start-up activities with clinical trial sites to support trial start-up strategies
• Provides system and device expertise to train and support clinical trial sites
• Ensures ongoing collection and review of relevant documentation e.g., related to protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP guidelines
• Provides support to prepare for and follow-up on audits and inspections
• Shares information, collaborate, and provide relevant input and guidance to other areas within NACD, CMR and global partners
• Demonstrates technical proficiency within responsible areas, stays up to date on new practices systems, and technologies while building knowledge of emerging trends and advances within area
• Contributes actively to Trial Core Team and other relevant teams

 

Physical Requirements

0-10% overnight travel required; May be required to work company holidays and weekends.

 

Qualifications

• A Bachelor’s degree (science-related discipline preferred) or a Registered Nurse (RN) degree is required
• A minimum of 3 years of experience in the planning and conduct of GCP clinical trials, some of more recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare setting required
• A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required
• Relevant Novo Nordisk experience will apply where appropriate
• Site activation and site management/monitoring experience is an asset
• Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
• Demonstrated computer skills (MS Office, clinical trial systems) and adaptability to new systems
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and s