Global Study Manager Job at iconplc

Global Study Manager

As a Global Study Manager at ICON, you will be responsible for leading and manag...

Location

Canada

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in project management, with a proven track record of leading successful projects in the pharmaceutical or biotech industry
Strong proficiency in project management tools and methodologies, with excellent attention to detail
Excellent analytical and problem-solving skills, with the ability to develop effective project strategies
Demonstrated leadership skills, with experience in managing and mentoring teams effectively
Exceptional communication skills, with the ability to convey technical concepts to diverse audiences
Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment
Willingness to travel as required (approximately 25%)

Job Responsibility

Managing day-to-day project and program management activities, supporting your team to deliver quality outcomes
Developing and executing project plans, focusing on achieving project goals and objectives
Leading cross-functional teams to ensure the successful implementation of project activities
Collaborating with stakeholders to identify project requirements and define project scope
Mentoring and guiding team members, fostering a culture of excellence and continuous improvement
Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner
Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies
Contributing to organizational growth through effective project leadership and strategic planning

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

Global Study Manager

As a Clinical Trial Manager II at ICON, you will design and analyse clinical tri...

Location

Hungary , Budapest

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, with a minimum of 6-7 years of experience in clinical trial management
Proven expertise in designing and executing clinical trials, with a strong understanding of regulatory requirements
Exceptional analytical and problem-solving skills, with the ability to interpret complex medical data
Effective communication and interpersonal skills, with the ability to collaborate across diverse teams
Detail-oriented and organized, with a track record of successfully managing multiple tasks and priorities simultaneously
Willingness to travel as required (approximately 25%)

Job Responsibility

Collaborate with cross-functional teams to design and implement effective clinical trial enrollment
Collaborating with cross-functional teams to develop and implement comprehensive clinical trial protocols
Overseeing and managing the day-to-day operations of clinical trials, ensuring compliance with regulatory standards
Analyzing and interpreting clinical trial data, identifying trends, and providing insights to optimize study outcomes
Proactively addressing challenges and implementing effective solutions to ensure the successful execution of clinical trials
Communicating effectively with internal and external stakeholders to foster strong partnerships and facilitate smooth trial processes

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

Global Study Manager

Global Study Manager. ICON plc is a world-leading healthcare intelligence and cl...

Location

Spain , Barcelona

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree (preferably in life sciences or related field)
At least 5 years’ experience in clinical research, with 3+ years in Global clinical project management/ Global Study Manager within a Pharma or CRO
Strong knowledge of clinical research regulations (ICH-GCP)
Proven ability to deliver projects on time, within budget, and to quality standards
Experience working with internal teams and external vendors including vendor set up, management and vendor budgets. (eg. central labs, IRT etc)
Excellent communication, teamwork, and problem-solving skills
Ability to manage multiple priorities and work in a matrix environment
Experience in all phases of clinical study lifecycle
Experience in using AI automation in your daily work as a GSM
Knowledge of GXP outside of GCP (e.g., GMP, GLP).

Job Responsibility

Support the planning, setup, execution, and close-out of global clinical studies
Oversee vendors and country teams to ensure smooth study delivery
Work closely with internal teams and external partners
Help develop and update study documents (e.g., protocols, informed consent forms)
Manage third-party vendors, including contracts and budgets
Ensure all study activities comply with regulations (ICH-GCP), SOPs, and best practices
Contribute to meetings, audits, and inspections
Support risk management and quality assurance efforts
Maintain accurate study documentation and ensure inspection readiness at all times.

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

Global Study Manager

Global Study Manager – This position is a fully client-embedded role, dedicated ...

Location

Poland

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

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

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

Fulltime

Global Study Manager

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

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field
Minimum of 5 years of experience in global clinical trial management
Proven expertise in designing and executing clinical trials
Strong understanding of regulatory requirements
Exceptional analytical and problem-solving skills
Ability to interpret complex medical data
Effective communication and interpersonal skills
Ability to collaborate across diverse teams
Detail-oriented and organized
Track record of successfully managing multiple tasks and priorities simultaneously

Job Responsibility

Collaborate with cross-functional teams to design and implement effective clinical trial enrollment
Collaborate with cross-functional teams to develop and implement comprehensive clinical trial protocols
Oversee and manage the day-to-day operations of clinical trials
Ensure compliance with regulatory standards
Analyze and interpret clinical trial data
Identify trends and provide insights to optimize study outcomes
Proactively address challenges and implement effective solutions to ensure successful execution of clinical trials
Communicate effectively with internal and external stakeholders to foster strong partnerships and facilitate smooth trial processes

What we offer

Various annual leave entitlements
Range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits

Fulltime

Global Study Manager II

Parexel is actively recruiting for an experienced Global Study Manager to join u...

Location

Poland

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies

Job Responsibility

Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
Steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

Fulltime

Global Study Manager II

Parexel is actively recruiting for an experienced Global Study Manager to join u...

Location

Poland; Spain; Serbia; Romania

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies

Job Responsibility

Provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI's
Steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed
Support authority/ethics response to requests as applicable

Fulltime

Global Clinical Study Manager

We are seeking a highly motivated and experienced Clinical Study Manager (CSM) t...

Location

Canada , Montréal

Salary:

Not provided

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Master’s degree in a relevant field, and 6+ years of demonstrated work experience as a Regional Clinical Project Manager or Clinical Study Manager
candidates with a Bachelor’s degree and 8+ years of related experience will also be considered
strong working knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical trial management
previous experience as a CRA, or experience working at clinical sites
strong organizational and project management skills, with the ability to prioritize and manage competing deadlines
bilingual with excellent communication skills, both written and verbal, and have the ability to collaborate effectively with internal teams, external vendors, and clinical investigators
proficient in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software

Job Responsibility

Overseeing the global strategy of clinical trials, including study planning, execution, monitoring, and close-out
ensuring clinical studies are conducted in accordance with the approved protocol, Good Clinical Practice (GCP), and applicable regulations
acting as the primary Sponsor contact for Global CRO Project Directors and Global functional leads
partnering with Clinical Project Managers (CPMs) to translate global recruitment targets into country-specific execution plans
developing and reviewing study plans, protocols, and related documents, while overseeing site selection, feasibility assessments, and the development of study materials
ensuring studies adhere to regulatory requirements and ethical standards, handling regulatory inspections and audits, and implementing corrective actions when necessary
developing and managing project timelines, milestones, and budgets, ensuring all deliverables are met within the agreed-upon timeframe and budget
identifying potential risks to the study, developing mitigation strategies, and taking appropriate action to resolve issues as they arise during the course of the study
overseeing the collection, analysis, and reporting of clinical trial data, ensuring data integrity and quality, accurate data handling, and compliance with data protection regulations
monitoring and ensuring the safety and welfare of study participants by adhering to safety reporting guidelines and promptly addressing any safety concerns

What we offer

equity
annual bonus dependent on team and company performance
a 6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
opportunity for flexible work arrangements
professional development opportunities
comprehensive health benefits
scientific and technical mentorship

Fulltime

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Global Study Manager

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