Principal Monitoring Compliance Assessor for EMEA - UK Based
- Experience Level
- Experienced (non-manager)
At Syneos Health, we are currently looking for a Principal Monitoring Compliance Assessor to join our team. The candidate will work with Clinical Operations representatives and other Company functions and services to develop and revise Clinical Monitoring SOPs and WIs. also, will identify process improvement to reduce risk and assists in ensuring consistent monitoring practice and activities during the conduct of a clinical trial. Nevertheless, will work with Line Managers, Clinical Leads and/or Project Leads to conduct quality oversight assessments and activities for the identification of risks related to the performance of Site Monitors and Clinical Leads; and investigational sites. Leads and/or participates in other projects and initiatives within Clinical Operations Support and Qualification (COSQ) and with other company departments.
- Assists in the development and review of Company Controlled Documents in support of the Clinical Monitoring SOP Liaison; may serve as an Author of a Controlled Document
- Develop and revise controlled documents as required by audit/inspection findings, changes in regulations or process, identification of gaps and user feedback
- Review controlled documents from other functions to ensure alignment with clinical monitoring activities. Provide structured feedback on functional area controlled documents, including rationale for any changes, alternative suggestions and insight into Clinical Monitoring processes where alignment is required.
- Assists in the development of processes within the department and Company, which contribute to higher quality individual and global monitoring performance, development and job satisfaction.
- Identifies training needs for site monitors and Clinical Leads through the analysis of performance data to meet best practice standards in quality and efficiency across global clinical operations, in conjunction with Global Training and management.
- Assists and supports Global Training in the development of appropriate tools and materials. Acts as the Subject Matter Expert
- Perform Monitoring Evaluation Visits (MEVs) and Sign-Off Visits (SOVs) and activities, as required, in their assigned region. Completes all applicable preparation and follow-up to support and conduct the visit/activity.
- Assists other MCAs and Business Unit Assessors with MEVs and SOVs and activities as needed.
- Utilizes the Clinical Monitoring Quality Oversight System (CMQOS) to record MEVs and SOVs and activities and follows any action items until submission and finalization. Develops and maintains necessary technical skills associated with the CMQOS.
- Assists with the surveillance and analysis of performance data and indicators (i.e. MEV and audit findings) to identify individual and/or aggregate trends and assist in the development of action plans or remediation activities.
- May provide back-up support to Associate Directors and Directors in the department.
- May serve on the Clinical Monitoring Training Functional Council
- Performs other work-related duties as assigned.
BA/BS degree in business or life sciences preferred, and moderate clinical research experience in the
pharmaceutical, CRO, or SMO industry, including field monitoring experience or equivalent
combination of education and experience.
Project Management/Clinical Lead experience preferred.
Experience in leading projects, programs or initiatives preferred
Thorough knowledge of ICH-GCP, regulatory requirements, drug development, and clinical
Must be able to work independently or across multiple departments, projects, geographical locations
and organizational levels to accomplish business goals
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
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.