Job Description
* Coordinates investigator/ site feasibility and identification process, as well as study startup.
* Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
* Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
* 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.
* Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
* Coordinates planning of supervised monitoring visits and conducts the visits.
* Manages the project team in site contracting and payments.
* Leads project team calls on a country level as well as providesstatus updates and reports to Regional Lead/ Project Manager.
* 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.
* Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
* Delivers trainings and presentations at Investigator Meetings.
* Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
* 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 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.
* Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
* Conducts project-specific training of site Investigators.
* Supports preparation of draft regulatory and ethics committee submission packages.
Qualifications
* 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 4years’ site monitoring experience with participationin global clinical projects as a Lead Monitor or equivalentqualificationlevel.
* Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
* Experience with all types of monitoring visits in Phases I-III.
* Strong experience in Oncology preferred.
* Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
* Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
* Full working proficiency in English.
* 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 up to 65% (depending on project needs).
* Valid driver’s license (if applicable).
#J-18808-Ljbffr