Lead Clinical Research Associate

PSI is a leading Contract Research Organization (CRO) with over 30 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications. In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. More than 25% of our colleagues have been with us for over 10 years, contributing to our long-standing traditions and history. At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally. We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry. As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams. This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality. Responsibilities: - Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures. - Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. - Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. - Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. - Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. - Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. - Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. - Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. - Ensures data integrity and compliance at a site level. - Collaborates with investigator/ site feasibility and identification process, as well as study startup. - Manages Monitors in the query resolution process, including Central Monitoring observations. - Coordinates safety information flow and protocol/process deviation reporting. - Performs clinical supplies management with vendors on a country and regional level. - Ensures study-specific and corporate tracking systems are updated in a timely manner. - Coordinates planning of supervised monitoring visits and conducts the visits. - Manages the project team in site contracting and payments. - Ensures ongoing evaluation of data integrity and compliance at a country/regional level. - Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. - Oversees project team in CAPA development and implementation. - Coordinates project team in process deviations review, management and reporting. - Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. - Delivers trainings and presentations at Investigator Meetings. - Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. - Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. - Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. - Supports preparation of draft regulatory and ethics committee submission packages. - Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. - Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. - Experience with all types of monitoring visits in Phase II and/or III. - Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable. - Full working proficiency in English and Thai. - Proficiency in MS Office applications. - Ability to plan, multitask and work in a dynamic team environment. - Excellent Communication, collaboration, and problem-solving skills. - Ability to travel. Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.