Description
Quality and Compliance AssessorSyneos 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.
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.
Job Responsibilities
- Performs Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and/or Sign Off Visits (SOVs) as assigned.
- Assists in the analysis of qualitative oversight data to identify quality improvement signals.
- Conducts root cause analysis of the quality signals and develops a plan and/or recommended action(s) that may include assisting with implementation of process and efficiency improvements.
- Identifies training needs for CRAs through the analysis of aggregated oversight data to meet expected standards in quality and efficiency across Global Clinical Operation (GCO).
- May conduct training on areas of improvement as identified through the quality oversight data analysis and/or audit and inspection findings in collaboration with Learning Center of Excellence, Corporate Quality and Clinical Operations Management.
- Supports Clinical Operations in addressing ad hoc or escalated quality concerns within region.
- Acts as consultant to local/regional operations related to quality oversight best practices and tools.
- May assist in the review of Clinical Monitoring SOPs, tools or templates related to monitoring oversight.
- Performs other work-related duties as assigned.
Requirements:
- Bachelor's degree in biological science or healthcare-related field required
- Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech or large pharmaceutical company
- Additional industry experience as a CRA Line Manager, Project Manager, Clinical Team Manager or Quality Control role preferred
- In-depth knowledge of ICH/GCP, local regulations, drug development process and clinical operations required
- Knowledge of multiple therapeutic areas
- Must be able to work independently within a matrixed environment across multiple projects, geographical locations and organizational levels to accomplish business goals
- Strong attention to detail with excellent organizational, documentation and presentation skills
- Strong interpersonal and communication skills with the ability to identify and solve problems and communicate issues tactfully
- Ability to perform root cause analysis
- Ability to manage required travel of up to 75% on a regular basis; including internationally
- Proficiency in written and spoken English with additional languages preferred in regional locations
- where the assessor will support multiple countries
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.
http://www.syneoshealth.com
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.
Summary
The Quality and Compliance Assessor will collaborate with Clinical Research Associate （CRA） line management to conduct quality oversight activities of CRAs to achieve consistent, high-quality performance and output for our clients. Coordinates analysis of aggregated quality oversight data and communicates findings to CRA line management and Clinical Operations leadership with critical attention to addressing issues with solution-oriented proposals.
