- 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 provides status 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.
- 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 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor.
- Experience with all types of monitoring visits in Phase II and/or 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.
- 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).
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
