Global Study Manager Job at iconplc

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, CSAR - Global Library

The Global Library Manager will report to the Sr. Manager, Clinical System and A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience
Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience
Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience
Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
General project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
Good Clinical Practice knowledge
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Knowledge of drug development and clinical trials processes
Knowledge of data management processes

Job Responsibility

Support of clinical trial platform technologies
Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight
Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems
Coordinating and providing programming support to Clinical Study Teams
Maintaining standard business processes within GDO to ensure compliance to regulatory bodies
Acting as a technical point of contact for systems deliverables on defined programs
Providing technical and business process input / expertise on new and emerging technologies
Develop, review and implement policies, SOPs and associated documents
Assist in preparing for and responding to audit findings (internal or external)
Provide Global Library review at the study level

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Global Trial Manager - Early Development

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

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and 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

Country Study Operations Manager I - FSP

Key Accountabilities: Study Management Oversight; Study Management Operations; S...

Location

Turkey

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
Comprehensive knowledge of own discipline with good knowledge of other disciplines
Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
Demonstrated clinical research experience and/or study management/startup project manager experience
Demonstrated experience in managing country level operational activities and/or vendors
Experience in study and quality management
Knowledge of clinical trial methodology

Job Responsibility

Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) 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 [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM 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
May be responsible and accountable for, as designated by the GSM: Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)
Regional, country and study level recruitment strategy

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.

Senior CTM

A South San Francisco based pharmaceutical company is looking for a Contract Sen...

Location

United States , South San Francisco

Salary:

Not provided

Solomon Page

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in a relevant scientific discipline
Minimum 7 years of pharma or biotech industry experience managing clinical trials
Sponsor experience required
Global Study Management experience in Phase III required
CRO & Vendor Management experience required
Metabolic, Cardiovascular, or Diabetes experience required
Proven experience driving enrollment and retention strategies for large, complex patient populations in global clinical trials.

Job Responsibility

Lead global cross-functional study teams through all study stages
Provide support and contribute to RFP/RFI process, analyze service providers, budgets/proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements)
Manage CRO and service providers
Assist with Inspection Readiness activities
Manage clinical study timelines with PM Team
Develop study documents such as CRF design, project plans, Service Provider Oversight plans
Manages study sites and study related activities (site selection, start up, recruitment, enrollment, study management, monitoring report review, and more)
Provide regular updates to Study lead and other stakeholders
Proactively identify, manage, or escalate issues appropriately
Work with Finance to manage budget for studies and vendors

What we offer

Medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits.

Senior CTM (Phase 1)

A South San Francisco based pharmaceutical company is looking for a Contract Sen...

Location

United States

Salary:

Not provided

Solomon Page

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in a relevant scientific discipline
Minimum 7 years of pharma or biotech industry experience managing clinical trials
Sponsor experience required
Global Phase I experience required
US and Global experience required
CRO & Vendor Management experience required

Job Responsibility

Lead global cross-functional study teams through all study stages
Provide support and contribute to RFP/RFI process, analyze service providers, budgets/proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements)
Manage CRO and service providers
Assist with Inspection Readiness activities
Manage clinical study timelines with PM Team
Develop study documents such as CRF design, project plans, Service Provider Oversight plans
Manages study sites and study related activities (site selection, start up, recruitment, enrollment, study management, monitoring report review, and more)
Provide regular updates to Study lead and other stakeholders
Proactively identify, manage, or escalate issues appropriately
Work with Finance to manage budget for studies and vendors

What we offer

medical
dental
vision
401(k)
telehealth services
ESOP
commuter benefits

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

Global Study Manager

iconplc

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 14, 2026

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