Description

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Risk Advisor -Risk-Based Quality Management (RBQM)

Are you a strategic thinker with a passion for ensuring clinical trials run smoothly and efficiently?  Do you have a deep understanding of RBQM, risk-based monitoring, quality-by-design, risk and issue management, root causes analyses, and the cross-functional interfaces of RBQM? 

Join us as a Risk Advisor in Risk-Based Quality Management (RBQM), where you'll play a pivotal role in driving excellence in clinical trials. This role offers the unique opportunity to shape risk management strategies and lead the implementation of RBQM processes, all while collaborating with top-tier professionals in this industry.

What You'll Do:

• Lead the Charge: Steer clinical trial teams through the intricacies of RBQM, providing expert guidance and training that elevate our risk management practices.
• Strategic Advising: Work closely with study teams to craft robust risk plans, ensuring a collaborative approach that enhances overall risk management.
• Risk Assessment: Contribute to the identification and analysis of potential risks, setting thresholds, and developing effective mitigations and performance indicators.
• Monitoring Excellence: Assist in determining monitoring requirements aligned with study and site-specific risks, ensuring optimal outcomes.

Qualifications

What We're Looking For:

• Seasoned Professional: Deep understanding of RBQM, risk-based monitoring, quality-by-design, risk and issue management, root causes analyses, and the cross-functional interfaces of RBQM
• Risk Management Expert: At least 2 years of hands-on experience advising with risk-based monitoring plans; RACT Risk Assessments, 
• Influential Leader: Proven ability to lead and inspire across various functions and cultures, demonstrating exceptional interpersonal and negotiation skills.
• Tech-Savvy Analyst: Proficiency in Salesforce, Microsoft Office, strong analytical skills, and an aptitude for data analytics.
• Communicator Extraordinaire: Outstanding verbal and written communication skills, with the ability to present complex information clearly and effectively.
• Detail-Oriented Thinker: Keen strategic thinking and problem-solving abilities, with a meticulous approach to managing data trends and risks.
• Self-Starter: Excellent organizational and time management skills, with the capability to prioritize and deliver results independently.
• Regulatory Knowledge: Deep understanding of FDA, EMA, and ICH GCP regulations, with experience in Phase 1-3 clinical studies and various functional areas of study teams.

If you're ready to take on a dynamic role that combines risk management expertise with leadership and innovation, we want to hear from you! Apply today and be part of a team that is redefining the future of clinical trials.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.