FSPxGlobal Pharma Location: Shanghai client office based, Jingan district, Park Place Therapeutic area: global phase II-III studies in Oncology, Immune and Respiratory, Diabetes and CNS
Description Monitoring Compliance Assessor (MCA) Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. 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 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.
