Trial Delivery Management (Base) Job at iconplc (Blue Bell)

New

Trial Delivery Management (Base) - Immunology

As a Trial Delivery Management (Base) at ICON, you will be responsible for leadi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in project management, business, or a related field is preferred, with significant experience in project management and team leadership
Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints
Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks
Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations
Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous
Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement
Willingness to travel as required (approximately 30%)

Job Responsibility

Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery
Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration
Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track
Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives
Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders

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

Study Start-up Manager

Drive the planning and execution of clinical study start-up activities, ensuring...

Location

United Kingdom , Cambridge; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Previous experience leading people/teams and working in global teams across multiple geographies
Project management experience
Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
PMP Certification

Job Responsibility

Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met
Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track
Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration
Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start
Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed
Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution
Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities
Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

New

Local Study Operations Line Manager

Location

Hungary , Budapest

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country's study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Work in close partnership with the Country GSSO Head to help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs' fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team

What we offer

Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development

Fulltime

New

Local Study Operations, Senior Manager

Location

Australia , Sydney

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the skill development of Local Study Operation Managers (LSOM's), ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio

What we offer

health, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities

Fulltime

Study Delivery Senior Manager

In this vital role, you will own global clinical trial delivery, translating pro...

Location

United Kingdom , Cambridge; London; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience and previous people leadership managing teams, projects, resources or directing the allocation of resources
Previous experience in life sciences or a related field, including biopharmaceutical clinical research
Previous management experience of direct reports across multiple geographies
Experience representing a sponsor company in regulatory audit/inspections
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

Job Responsibility

Leading cross-functional study teams to deliver clinical data aligned with evidence generation strategy
Defining and executing study plans covering feasibility, site selection, site engagement, recruitment, retention, and vendor delivery
Identifying and managing study risks using quality-by-design and risk-based approaches to protect participant safety and data integrity
Overseeing global study execution, including enrollment, data flow, monitoring, and corrective actions
Providing clear leadership, issue resolution, and escalation management across geographies
Partnering effectively with internal stakeholders and external vendors to ensure performance and collaboration
Driving continuous improvement, innovation, and regulatory compliance throughout the study lifecycle

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Client Delivery Manager

The Client Service team connects Guidepoint’s clients with subject-matter expert...

Location

United Kingdom , London

Salary:

Not provided

Modoras Accounting Syd

Expiration Date

Until further notice

Requirements

Bachelor’s/Master's degree and a strong academic record required
Desire to work in a client facing project management role that is KPI and metrics-driven
Ability to work in a fast-paced, results-oriented environment
Excellent time management and organizational skills
Outgoing personality with the ability to speak with people at all professional levels
Intellectual curiosity and desire to learn
Excellent written and verbal communication skills
Demonstrated ability to work both individually and as part of a team
Fluency in English is a must

Job Responsibility

Manage and retain existing client accounts
Penetrate multiple users
Provide excellent customer service
Grow client accounts
Send multiple screened, quality advisors per project asap
Contact client to obtain new projects
Push events, teleconferences or new advisors
Penetrate user base
Convert Trials to full clients through excellent service during trial period

What we offer

Competitive salary, bonus and benefits
Excellent medical coverage through BUPA
Excellent professional development opportunities
Supportive culture that celebrates and rewards success
Monthly Happy Hour, Social Events, Summer Fridays
Year-round company sponsored sports and team building events
Informal work environment
Employee Assistance Programs
Volunteer days

Fulltime

Data Management Lead

At Parexel, we are dedicated to advancing clinical research and supporting medic...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience
7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
Medical affairs experience (Phase IIIB - IV trials experience)
Late Phase Oncology
Strong project management experience
Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required)
Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity
Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing
Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques
Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment

Job Responsibility

Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects
Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones
Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models
Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data
Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results
Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis
Manage and coordinate the integration and utilization of all ancillary systems
Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan
Review and analyze metrics to derive meaningful summaries of study health and trends
Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators

Data Management Lead

At Parexel, we are dedicated to advancing clinical research and supporting medic...

Location

United States , San Francisco

Salary:

99000.00 - 180000.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience
7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
Medical affairs experience (Phase IIIB - IV trials experience)
Late Phase Oncology
Strong project management experience
Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required)
Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity
Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing
Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques
Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment

Job Responsibility

Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects
Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones
Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models
Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data
Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results
Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis
Manage and coordinate the integration and utilization of all ancillary systems
Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan
Review and analyze metrics to derive meaningful summaries of study health and trends
Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators

What we offer

Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings in accordance with the terms of applicable plans
Annual performance-based bonus plan (for eligible roles)
Annual salary review
Total rewards incentives (for eligible roles)

Fulltime

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Trial Delivery Management (Base)

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