Country Study Operations Manager Job at iconplc (Seoul)

Senior Study Specialist, Global Study Operations

The Sr. Study Specialist (SS) significantly contributes to or leads tasks relate...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS or higher in nursing, life or health sciences is preferred
Industry or relevant experience in lieu of education is considered
Experience in a biotechnology or pharmaceutical company
Experience in oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
Proficient knowledge and experience in Agility and Proactivity, Leadership, Communication and Collaboration, Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge

Job Responsibility

Develop study specific documentation, as delegated by the Study Manager
Contribute to the oversight of country and site feasibility assessment and site selection
Oversight of CRO for IRB/EC related submission/approval activities
Oversight of essential documents for study life-cycle management
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
Process documents for signature in DocuSign
Oversight of Clinical Trial Insurance

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Ux Research Operations Manager

Our FinTech client is looking for a UX Research Operations Manager to join their...

Location

United States , Menlo Park

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

3+ years of experience working with researchers in an operational capacity
proven ability to work independently and deliver results in a highly organized manner
strong communication skills to interact with researchers, internal stakeholders, and study participants
a passion for the mission of improving access and accessibility in financial systems
a dedication to professionalism and attention to detail in your work

Job Responsibility

Managing the maintenance and disposal of customer PII and study artifacts (where data is stored and how it’s protected) and serving as the team expert on data privacy regulations
unlocking new methodologies and/or expanding research capabilities in additional countries
coordinating internal security approvals for new vendors and tools for the team
standardizing compliant and transparent consent forms while streamlining related processes
leading ongoing regulatory compliance reporting
maintaining a research archive of past reports

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks
Excellent attention to details
Excellent knowledge of spoken and written English

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Clinical Trial Manager

Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to joi...

Location

United States , Cambridge

Salary:

125000.00 - 155000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials
Phase I experience is strongly preferred
a background in rare disease and/or metabolic disorders is highly desirable
experience with cell & gene therapy is a plus
Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes
Exceptional organizational skills and ability to deal with competing priorities
strong reasoning and problem solving ability
Ability and willingness to travel up to 20% (domestic and international)

Job Responsibility

Manage all project team activities related study start up, conduct and close out activities
Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget
Manage Change Orders with Sites (and Vendors when necessary)
Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF
Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities
Contribute to (or oversee the management of) the creation of the trial plans and site facing documents
Develop (or overseeing the development of) all training/day to day materials
Support data management activities
Monitor (and escalate appropriately) vendor metrics and vendor performance
Organize, oversee and/or participate in all study related meetings

Fulltime

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Senior Clinical Trial Manager

At Hemab you will join a clinical-stage biotech company on an exciting journey t...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in life sciences or healthcare discipline
At least 5-7 years of clinical trial management experience and at least 2 years of clinical monitoring experience in the biotech/pharmaceutical industry
Proven experience managing Phase 3 clinical trials from initiation through completion
Direct experience conducting global/multinational clinical trials across multiple geographic regions (US, EU, MENA, Asia-Pacific preferred)
Experience in rare disease or orphan drug development, with demonstrated understanding of unique challenges in patient recruitment, regulatory pathways, and engagement with specialized centers
Working knowledge of ICH/GCP regulations and guidelines
Solid understanding of cross-functional areas, including data management/biostatistics, regulatory affairs, and pharmacovigilance
Proven verbal and written communication skills
enjoys interacting with others regularly
Able to prioritize tasks and work independently

Job Responsibility

Manage CRO study team(s), clinical sites, laboratory vendor(s), and other outsourced work on assigned studies to ensure consistency of methods, interpretation, and approach with other Hemab-sponsored studies
Lead global clinical trial execution across multiple regions and countries, ensuring coordination of multinational study teams and compliance with regional regulatory requirements
Lead in the development and review of protocols, study budgets, investigator brochures, clinical study reports, and other clinical documents and regulatory filings as needed
Implement study startup activities, including the development of informed consent forms, study training materials, manuals, plans, and study tools for assigned study
Oversee regulatory/ethics submissions
Effectively evaluating qualified study sites, oversee monitoring activities, and support clinical site initiation visits, co-monitoring, and close-out visits as needed
Oversee day to day study conduct
including management of operation questions from CRO and sites, tracking subject recruitment, laboratory samples, and review of monitoring reports
responsible for study close-out activities
Assess study drug requirements and shipment and supply logistics, contributing to pharmacy manual

Fulltime

Clinical Research Associate (Start Up) - Cross TA

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Miami

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Must be located in Miami, FL
near a major airport.
Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
Knowledge of several therapeutic areas
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).

Job Responsibility

Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
Build strong relationships with site personnel to facilitate a smooth onboarding process.
Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
Proactively identify and address any issues that may delay study initiation or affect trial deliverables.

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Fulltime

Country Study Operations Manager

iconplc

Location:
South Korea , Seoul

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 26, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Country Study Operations Manager

Senior Study Specialist, Global Study Operations