PpbJob Description /b /p /ppAs 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. /ppbThis 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. /b /ppResponsibilities: /pliMonitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures. /liliReviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. /liliActs as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. /liliLeads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. /liliProvides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. /liliSupervises 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. /liliEnsures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. /liliReviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. /liliEnsures data integrity and compliance at a site level. /liliCollaborates with investigator/ site feasibility and identification process, as well as study startup. /liliManages Monitors in the query resolution process, including Central Monitoring observations. /liliCoordinates safety information flow and protocol/process deviation reporting. /liliPerforms clinical supplies management with vendors on a country and regional level. /liliEnsures study-specific and corporate tracking systems are updated in a timely manner. /liliCoordinates planning of supervised monitoring visits and conducts the visits. /liliManages the project team in site contracting and payments. /liliEnsures ongoing evaluation of data integrity and compliance at a country/regional level. /liliConducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. /liliOversees project team in CAPA development and implementation. /liliCoordinates project team in process deviations review, management and reporting. /liliConducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. /liliDelivers trainings and presentations at Investigator Meetings. /liliEnsures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. /liliEnsures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. /liliSupervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. /liliSupports preparation of draft regulatory and ethics committee submission packages. /libr/ppbQualifications /b /p /pliRelevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. /lilibMinimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. /b /liliExperience with all types of monitoring visits in Phase II and/or III. /lilibStrong experience in Oncology preferred. /b /lilibExperience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred. /b /lilibStrong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. /b /liliFull working proficiency in English. /liliProficiency in MS Office applications. /liliAbility to plan, multitask and work in a dynamic team environment. /liliExcellent Communication, collaboration, and problem-solving skills. /liliAbility to travel. /liliValid driver’s license (if applicable). /lipbFor this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future. /b /pbr/ppbAdditional Information /b /p /p