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About the Role

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. 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

Monitor project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures.
Review monitoring visit reports for all visit types and ensure reporting compliance of the Monitors in the region.
Act as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Lead project team calls on a country level as well as provide status updates and reports to Regional Lead/ Project Manager.
Provide project-specific training and prepare training materials for the project team under supervision of a Project Manager and Regional Project Lead.
Supervise source data verification and follow up on data queries at site level in the country/region; review and manage study risks on a site level.
Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
Review essential study documents and supervise reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
Ensure data integrity and compliance at a site level.
Collaborate with investigator/ site feasibility and identification process, as well as study startup.
Manage Monitors in the query resolution process, including Central Monitoring observations.
Coordinate safety information flow and protocol/process deviation reporting.
Perform clinical supplies management with vendors on a country and regional level.
Ensure study-specific and corporate tracking systems are updated in a timely manner.
Coordinate planning of supervised monitoring visits and conduct the visits.
Manage the project team in site contracting and payments.
Ensure ongoing evaluation of data integrity and compliance at a country/regional level.
Conduct site audit preparation visits, may participate in site audits, and coordinate resolution of site audit findings on a country/regional level.
Oversee project team in CAPA development and implementation.
Coordinate project team in process deviations review, management and reporting.
Conduct initial training and authorization monitoring visits for Monitors and act as a mentor for newly promoted Lead CRAs.
Deliver trainings and presentations at Investigator Meetings.
Ensure that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervise Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
Support preparation of draft regulatory and ethics committee submission packages.

Requirements

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.
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.

Skills

Clinical monitoring
Global clinical projects
Phase II monitoring
Phase III monitoring
Oncology
Gastroenterology
Infectious diseases
Autoimmune diseases
Rare disease indication
English proficiency
MS Office proficiency
Planning
Multitasking
Teamwork
Communication
Collaboration
Problem-solving
Travel

Work Type

Low-travel model

Experience Level

Lead
Minimum of 4 years’ site monitoring experience

Education Level

MD
MPharm
RN
College/University degree in Life Sciences
Equivalent combination of education, training and experience

About the Company

PSI is a leading Contract Research Organization (CRO) with over 30 years of experience in the pharmaceutical industry.
PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents.
PSI is a stable and secure workplace with 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.
PSI fosters 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 about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.