CrawlJobs Logo

Global Study Manager

mygwork.com Logo

myGwork - LGBTQ+ Business Community

Location Icon

Location:
Poland

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Global Study Manager – This position is a fully client-embedded role, dedicated to a leading bio-pharma company. This position accountable for delivering the clinical operation activities of the study until study archiving. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality. The GSM role works in consultation with the Global Study Lead for end-to-end delivery of the clinical study.

Job Responsibility:

  • Accountable for delivering the clinical operation activities of the study until study archiving
  • Generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality
  • Accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overall study deliverables
  • Accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendors Oversight Plan, Investigator/CRA Meeting Set Up & associated training, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Safety Management plan, eTMF & vendor set -up
  • Proactively and effectively identifies, oversees, and mitigates study risks
  • Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
  • Accountable to operate within the study budget
  • Effectively leads empowered matrix teams
  • Responsible for operational input into protocol and informed consent form development, and other key study documents
  • Leads and conducts investigator meetings and other study related meetings
  • Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies
  • Oversees the activities of the countries participating in the study

Requirements:

  • Bachelor’s degree: life sciences or related discipline
  • At least 5+ years of relevant study management experience on a global level
  • In-depth experience in clinical research: study management, monitoring, data management
  • Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
  • Must have proven experience from study feasibility to CSR
  • Must have at least Ph II and PIII experience – PI & PIV is an asset
  • Must have cross-functional leadership proven experience, able to drive internal and external meeting
  • Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
  • Strong experience in clinical budget management
  • Strong experience with vendor management including CRO
  • Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset
  • Fluent in English, to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member
  • Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills
  • Demonstrates leadership skills, promoting motivation and empowerment of others
  • Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
  • Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

Nice to have:

  • Africa experience is an asset
  • PI & PIV experience is an asset
  • Being involved in studies pivotal for drug file registration is an asset

Additional Information:

Job Posted:
April 05, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Icon
myGwork - LGBTQ+ Business Community - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

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

Briefcase Icon

Similar Jobs for Global Study Manager

Manager, CSAR - Global Library

The Global Library Manager will report to the Sr. Manager, Clinical System and A...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Read More
Arrow Right

Global Trial Manager - Early Development

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
United States , CARY, BLUE BELL, RAHWAY, NJ
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
United States
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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.
Read More
Arrow Right

Senior CTM

A South San Francisco based pharmaceutical company is looking for a Contract Sen...
Location
Location
United States , South San Francisco
Salary
Salary:
Not provided
solomonpage.com Logo
Solomon Page
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits.
Read More
Arrow Right

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...
Location
Location
United States , Atlanta; Houston; Tampa; Dallas
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior CTM (Phase 1)

A South San Francisco based pharmaceutical company is looking for a Contract Sen...
Location
Location
United States
Salary
Salary:
Not provided
solomonpage.com Logo
Solomon Page
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • medical
  • dental
  • vision
  • 401(k)
  • telehealth services
  • ESOP
  • commuter benefits
Read More
Arrow Right

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
Location
Japan , Tokyo
Salary
Salary:
Not provided
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Global Study Director - Hematology/Oncology - Cell Therapy

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
  • Proven project management experience and training
  • At least 7 years of clinical trial experience
  • At least 3 years of experience in global study leadership and team leadership
  • Demonstrated clinical trial expertise in Hematology - Oncology
  • Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery
  • startup, maintenance and close out
  • Thorough understanding of the cross-functional clinical trial process eg. Data flow
  • Strong strategic and critical thinking abilities
  • Proven skillset and abilities in complex problem solving and decision-making
Job Responsibility
Job Responsibility
  • Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
  • Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection
  • Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required
  • Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended)
  • Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
  • For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
  • Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
  • Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
  • Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
  • Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations
What we offer
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
Read More
Arrow Right
Remote jobs Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog Salaries About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy