Job Description

Updated: Today
Location: Kuala Lumpur, 14, Malaysia
Job ID: 25002918
Description Quality and Compliance Assessor a?? Clinical Monitoring Excellence (Remote, 75% international travel may required)
Syneos HealthA 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.
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, youa??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 a?? 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 a?? wea??re able to create a place where everyone feels like they belong.

Job Responsibilities
What Youa??ll Do:
As a Quality and Compliance Assessor, you will:
a? Conduct rigorous Monitoring Evaluation Visits and Sign Off Visits with a sharp, auditora??s eyea??spotting whata??s working and where the cracks are.
a? Assess Clinical Research Associates and their competencies objectivelya??without bias or connectionsa??and coach them toward excellence.
a? Perform in-depth root cause analyses on quality signals, pinpointing problems and crafting actionable solutions to drive improvements.
a? Collaborate closely with CRA line management and Clinical Operations leadership to communicate findings and implement quality initiatives.
a? Analyze aggregated oversight data to identify trends, training needs, and opportunities to boost quality and efficiency.
a? Act as a trusted consultant on best practices in quality oversight, influencing SOP updates and clinical monitoring tools.
a? Travel extensively (up to 75%) to perform onsite visits, ensuring hands-on involvement with our global teams.
Who You Are:
a? A Senior-level CRA with solid experience in monitoring and/or auditing clinical research programsa??your expertise speaks volumes.
a? Exceptionally organized and detail-oriented, with a natural ability to assess complex data and documentation critically.
a? Skilled in root cause analysisa??you dona??t just identify problems, you lead solutions.
a? Fluent in English
a? A passionate mentor, creating innovative training tools that uplift the entire team.
a? A collaborative leader who enjoys teaching, coaching, and developing others.
a? Comfortable working remotely within a highly collaborative team environment
a? Ready to embrace travel as a core part of your role, including international trips.
a? Extensive knowledge of ICH/GCP guidelines, local regulations, and multiple therapeutic areas.
What you Bring:
a? Bachelora??s degree in biological sciences, healthcare, or related field required.
a? Minimum 5+ years as a CRA with demonstrated monitoring and/or auditing experience.
a? Extensive experience monitoring and/or auditing in CROs, biotech, or pharma.
a? Strong knowledge of global clinical trial regulations and quality standards.
a? Ability to thrive in a matrixed, fast-paced, geographically diverse environment.
a? Proven ability to mentor and develop junior CRAs and build effective training tools.
a? In-depth knowledge of clinical monitoring SOPs, regulatory requirements, and drug development processes.
a? Strong communication and interpersonal skills to tactfully address performance and quality issues.
a? Experience conducting performance assessments for CRAs because you truly know what excellent looks like.
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, youa??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 . 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.
Summary Elevate Quality. Drive Compliance. Lead with Integrity. Are you a seasoned clinical research professional passionate about ensuring the highest standards of quality and compliance? Ready to take your expertise beyond monitoring and auditinga??to coach, assess, and transform clinical operations? Join us as a Quality and Compliance Assessor and be the critical force behind elevating operational quality standards and performance in clinical monitoring. This is a remote role with exciting travel opportunities (up to 75%) that has a hands-on, pivotal role in shaping clinical quality oversight on APAC scale.
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