Job Description

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us.

The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees\xe2\x80\x99 personal and professional lives.

Position Summary:
This position is responsible for assisting the Clinical Operations department with managing clinical trials, including onsite co-monitoring, as needed.

Responsibilities:

• Participates in the development, execution, completion, and reporting of clinical trial(s) according to the regulations, on time and within budget.
• Assists in drafting study related documents (protocol, informed consents)
• Assists in start-up activities of clinical studies including Investigator Meetings, selection of trial sites and investigators.
• Assist in managing CRO\'s/ FSPs under the direction of study managers.
• Attend co-monitoring visits as needed.
• Reviews monitoring visit reports from CRO/FSP.
• Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.
• Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants.
• Writes, reviews, and / or provides input to study plans and guidelines.
• Manages trial related materials and vendors, e.g. investigational product supplies, ancillary supplies, central laboratories, central IRB, etc. as assigned.
• Assists with the electronic trial master file (eTMF) processes including set-up and QC.
• Ensures the quality control of critical documents.
• Collaborates with CRO/FSP counterpart on an ongoing basis.
• Performs monitoring (PSV, SIV, IMV, COV), as needed, of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant.

Qualifications and Skills Required:

• BS/BA degree in related field, preferably with a scientific background and 4+ years\xe2\x80\x99 experience in clinical development and operations
• Prefer at least 2 years\xe2\x80\x99 experience performing on-site monitoring conducting SIVs, IMVs, COVs and/or co-monitoring experience for IND regulated clinical research studies
• Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations
• Demonstrated effectiveness in resolving site management issues of varying complexity
• Strong analytical skills \xe2\x80\xa2 Proficient in Microsoft Office.
• Professional, proactive demeanor.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.

Our Values

• Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
• Accountability: We do what\xe2\x80\x99s right for our patient communities through quality decisions and owning our successes and failures.
• Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.

These three values come to life through our five Leadership Expectations that apply to all Horizon employees

• Enterprise Mindset: Look beyond one\xe2\x80\x99s team, brand or function to see the broader company and external perspective
• Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
• Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
• Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
• Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role

#LI-Remote

At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better.

Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Horizon Therapeutics