Jobs at PSI CRO (Now Hiring) — 321 open — Page 3

Lead Clinical Research Associate

Santiago, Santiago Metropolitan Region, Chile · Remote OK

Senior

Company Description PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering qu…

Skills: Clinical Research, Leadership, Mentorship, Monitoring, Compliance

Clinical Trials, Business Development Representative

Model, Colorado, United States · Hybrid

Mid level

Company Description Milestone One is a Site Enabling Organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need, and our mission is to strengthen study delivery by connecting …

Skills: Clinical research, Business development, Stakeholder management, Site relationship management, Communication

Clinical Research Associate II

Sydney, New South Wales, Australia · Hybrid

Mid level

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedica…

Skills: On-site Monitoring, CRF Review, Source Document Verification, Query Resolution, Site Budget Negotiation

Clinical Trials Business Development Representative (B2B Contract)

São Paulo, São Paulo, Brazil · Hybrid

Mid level

Company Description Milestone One is a Site Enabling Organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study d…

Skills: Business development, Clinical trials, Relationship management, Sales, Communication

Site Management Associate (Japanese Skill required)

Bangkok, Thailand · On-site

Mid level

Company Description PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a g…

Skills: Database Maintenance, Clinical Research Administration, Document Management, Vendor Management, Project Coordination

Pharmacovigilance Coordinator (Japanese Skills Required)

Prague, Prague, Czechia · On-site

Entry level

Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…

Skills: Pharmacovigilance, Clinical research, Data entry, Safety reporting, Japanese language

Compensation and Benefits Manager (Regional/Global)

Madrid, Community of Madrid, Spain · On-site

Senior

Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…

Skills: Compensation management, Benefits administration, Global pay market analysis, Job evaluation, Salary banding

Compensation and Benefits Manager (Regional/Global)

Kyiv, Ukraine · On-site

Senior

Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…

Skills: Compensation and benefits management, Global pay market analysis, Job evaluation, Salary banding, Incentive compensation

Compensation and Benefits Manager (Regional/Global)

Bengaluru, Karnataka, India · On-site

Senior

Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…

Skills: Compensation design, Benefits administration, Global pay market analysis, Benchmarking, Job evaluation

Compensation and Benefits Manager (Regional/Global)

Bucharest, Romania · On-site

Senior

Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…

Skills: Compensation design, Benefits administration, Global pay market analysis, Job evaluation, Salary banding

Data Manager for Clinical Trials

Milan, Lombardy, Italy · On-site

$34k–$52k/yr

Mid level

Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…

Skills: Clinical Data Management, eCRF Design, EDC Databases, Data Validation, Medical Coding

Pharmacovigilance Coordinator (Japanese Skills Required)

Bangkok, Thailand · On-site

Mid level

Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We foc…

Skills: Pharmacovigilance, Clinical research, Data entry, Safety reporting, Japanese language

Pharmacovigilance Coordinator (Japanese Skills Required)

Bangkok, Thailand · On-site

Entry level

Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We foc…

Skills: Pharmacovigilance, Clinical trials, Safety reporting, Data entry, Quality control

Pharmacovigilance Coordinator (Japanese Skills Required)

Bangkok, Thailand · On-site

Mid level

Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We foc…

Skills: Pharmacovigilance, Clinical Trials, Data Entry, Safety Reporting, Quality Control

Pharmacovigilance Coordinator (Japanese Skills Required)

Taipei, Taiwan · On-site

Entry level

Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We foc…

Skills: Pharmacovigilance, Clinical trials, Safety reporting, Data entry, Quality control

Pharmacovigilance Coordinator

Japan · Hybrid

Mid level

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. PSI is a leading Contract Research Organization with more than 30 years in the i…

Skills: Pharmacovigilance, Clinical trials, Safety reporting, Data entry, Quality control

Senior Statistician

Oxford, England, United Kingdom · On-site

Senior

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven,…

Skills: Biostatistics, Clinical trials, SAS programming, Statistical analysis, Protocol development

Senior Statistician

Prague, Prague, Czechia · On-site

Senior

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven,…

Skills: Biostatistics, Clinical Trials, SAS Programming, CDISC ADaM, Statistical Analysis

Senior Statistician

Madrid, Community of Madrid, Spain · On-site

Senior

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven,…

Skills: Biostatistics, Clinical trials, SAS programming, CDISC ADaM, Statistical analysis

Senior Statistician

Durham, North Carolina, United States · On-site

Senior

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven,…

Skills: Statistical Analysis, Clinical Trials, SAS Programming, CDISC ADaM, Biostatistics

Lead Clinical Research Associate

Santiago, Santiago Metropolitan Region, Chile • Remote OK

Senior

Tired of cold applications?

Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.

Full-time
bachelor degree
Posted 2d ago
~40 hrs/week
Remote in Santiago, Santiago Metropolitan Region, Chile

Responsibilities

The Lead Clinical Research Associate oversees and guides the clinical team while driving trial activities at a country or regional level. They ensure high-quality execution, compliance, and timely delivery of clinical projects through remote oversight and mentorship.

Requirements

Candidates must have a relevant degree in Life Sciences and a minimum of 4 years of site monitoring experience, including participation in global clinical projects. Proficiency in English and strong experience in monitoring Phase II/III trials are required.

Full job description

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

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.

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 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
Experience monitoring sites in the US.
Experience with all types of monitoring visits in Phase II and/or III.
Strong experience in Oncology preferred.
Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, 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.

Additional Information

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.

Related keywords

Clinical Research AssociateContract Research OrganizationClinical TrialsOncologyPhase IIPhase IIIMonitoring Visit ReportsInvestigational ProductISFTMFData QueriesCAPARegulatoryEthics CommitteeSite ManagementProject Management

About PSI CRO

LinkedIn Visit site

Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
Headquarters: Zug
LinkedIn followers: 356,747

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

Offices: Baarerstrasse 113a, Zug, 6300, CH

Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3

View all jobs at PSI CRO

About PSI CRO

LinkedIn Visit site

Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
Headquarters: Zug
LinkedIn followers: 356,747

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

Offices: Baarerstrasse 113a, Zug, 6300, CH

Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3

View all jobs at PSI CRO

Similar companies hiring

Allergan (2323)Johnson & Johnson Innovative Medicine (1811)Novartis (1420)MSD (1373)Takeda (1229)AstraZeneca (1229)Adelphi Group (997)Grifols (970)PiSA Farmacéutica (941)Sanofi (898)GSK (643)Bristol Myers Squibb (637)