Job Description :
Monitoring Compliance Assessor (MCA)
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
. #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
. 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.
. Performs Monitoring Evaluation Visits (MEVs), Sign-Off Visits (SOVs) and other evaluation activities, as required, in their assigned region. Completes all applicable preparation and follow-up to support and conduct the visit/activity.
. Assists other MCAs with MEVs, SOVs and other evaluation activities as needed.
. Identifies and recommends Required Improvement Actions (RIAs) resulting from a MEV, SOV and other evaluation activities to reduce risk and follows these RIAs until resolution and closure.
. Utilizes the Clinical Monitoring Qualification and Oversight System (CMQOS) to record MEVs, SOVs and other evaluation activities and completes all actions. Develops and maintains necessary technical skills associated with the CMQOS.
. Recommends training needs for Clinical and Central Monitoring teams through data analysis. In conjunction with management team provides recommendations to meet best practice standards in quality and efficiency across global clinical operations.
. Acts as the Subject Matter Expert to support development and delivery of tools and training materials to internal customers.
. Assists in the review of Company Controlled Documents in support of the Clinical Monitoring SOP Liaison.
. 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.
. Performs other work-related duties as assigned. Qualifications
What we're looking for
. 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.
. Thorough knowledge of ICH-GCP, regulatory requirements, drug development, and clinical procedures preferred.
. 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
. Ability to manage required travel of up to 75% on a regular basis.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.