Project Specialist - RBM focus (Spnsor-dedicated)

Project Specialist - RBM focus (Spnsor-dedicated)Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

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.

Job Responsibilities

Key Responsibilities

• Execute study-specific Risk-Based Monitoring strategies in alignment with regulatory requirements and internal quality standards.

• Analyze clinical and operational data to identify trends, risks, and potential issues impacting study conduct.

• Manage Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Quality Assessments (DQAs).

• Generate, evaluate, and communicate risk signals at the site, country, and study levels.

• Collaborate with monitoring and study teams to define and implement corrective and preventive actions.

• Escalate significant risks and track mitigation activities through to resolution.

• Support the development and continuous improvement of adaptive monitoring strategies.

• Coordinate monitoring activities based on study risk profile and operational priorities.

• Contribute to maintaining high standards of patient safety, data integrity, and regulatory compliance.

Required Qualifications

• Degree in Life Sciences, Pharmacy, Nursing, or a related field.

• Experience in clinical research, clinical operations, monitoring, or risk-based monitoring.

• Strong understanding of clinical trial processes, GCP, and regulatory requirements.

• Experience working with clinical trial data and performance metrics.

• Knowledge of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and centralized monitoring methodologies is highly desirable.

• Strong analytical and problem-solving skills.

• Excellent stakeholder management and communication abilities.

• Ability to work effectively in a cross-functional and global environment.

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.

Originally posted on Himalayas