Country Study Operations Manager Job at iconplc (Seoul)

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.

Study Operations Manager/Clinical Trial Manager - FSP

The Study Operations Manager I (SOM I) has responsibilities for study and region...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred

Job Responsibility

Serves as leader of the local study team on one or more studies
Provides back up to or assumes the responsibilities of the GSM as needed
Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
Provides country level input on startup and recruitment milestones during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
Fully responsible and accountable for, as designated by the GSM: Regional, country, and study level implementation of startup and site activation plans
Regional, country and study level recruitment strategy

Senior Clinical Trial Manager

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading th...

Location

United States , Madison

Salary:

91000.00 - 155000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in the life sciences or field as outlined in the essential duties
5+ years of experience in clinical research
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
Experience writing, reviewing and editing protocols
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)

Job Responsibility

Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Develop plans for systems and materials required to support the efficient execution of clinical studies
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
Develop study budgets and is responsible for accurately forecasting and managing study expenses
Oversee site contracting and study budget management
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

New

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

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

New

US Country Head, Global Study & Site Operations Director

Join Amgen’s Mission of Serving Patients. Provide strategic and operational lead...

Location

United States

Salary:

211385.00 - 252852.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of clinical execution experience
Master’s degree and 8 years of clinical execution experience
Bachelor’s degree and 10 years of clinical execution experience
At least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
+10 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection
Lead, line-manage, and develop the Country/Hub team
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles
Drive site engagement through a clearly differentiated Amgen site experience
Oversee country-level financial and operational management
Lead country governance and risk management
Ensure regulatory compliance, inspection readiness, and continuous improvement

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Japan Study Manager

Japan Study Managerは、日本国内において治験の管理・監督を担い、CROや治験実施医療機関と連携しながら、治験参加者の安全と福祉、治験の品質を確...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Study management and site management experience
Working knowledge of GCPs, monitoring, clinical and regulatory operations
BS – minimum of 4 years relevant experience
MS/PhD – minimum of 2 years relevant experience
Excellent writing and communication skills in both Japanese and English is required

Job Responsibility

Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards
Provides quality oversight to the CRO and of the CRO deliverables related to study execution
Leads and coordinates the execution of a clinical trial from study start-up through database release and inspection readiness to ensure timely delivery of quality study data
Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
Act as core member of the Study Team and will represent the CRO on matters of study execution
Accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g., study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g., site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction
Acts as local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc, and to oversee and support the site monitor in the conduct of clinical trials
This role is responsible for the resolution of protocol-related issues at the local level
Ensure timely communication with bidirectionally between global and local study team

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

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