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

New

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 (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

New

Global Study Director - Hematology/Oncology - Cell Therapy

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

Location

United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

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

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

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 Production Director

The Global Production Director is tasked with overseeing and advancing the plann...

Location

Spain , Madrid

Salary:

Not provided

Fever

Expiration Date

Until further notice

Requirements

8–10 years in live entertainment production with a focus on creative involvement
Strong leadership, creative evaluation, and project management skills
proven ability to manage multiple projects concurrently
Bachelor’s degree in Production, Fine Arts, Business, or a related field (or equivalent experience)
Familiarity with global live entertainment markets, regional nuances, and emerging industry trends
Availability to travel internationally as required

Job Responsibility

Develop comprehensive plans for permanent attraction projects by coordinating cross-functional teams to align on goals, budgets, and timelines
Conduct feasibility studies for potential expansion opportunities, assessing resource needs, estimated costs, and operational impacts
Drive the creation of a phased expansion roadmap, aligning with corporate growth strategies
Lead and manage production teams to deliver all projects within the agreed scope, ensuring adherence to schedules and budgets
Establish and implement standardized production processes to maintain consistency and quality across various project types and across geographies
Act as a key decision-maker for high-stakes issues related to technical requirements, resource allocation, and vendor selection
Assess current work methods / production workflows / local processes and challenge proposed approaches and provide creative alternatives, suggestions to improve ongoing projects
Build, train, and manage production teams specializing in permanent attractions
Support the professional growth of team members through ongoing training, mentoring, and performance feedback
Ensure local producers have the necessary tools, resources, and guidance

What we offer

40% discount on all Fever events and experiences
Work in the centre of the city with opportunities to travel
Responsibility from day one and professional and personal growth and the opportunity to have a real impact in a high-growth global category leader
Health and dental Insurance
Wellhub membership
Flexible remuneration plan
Great work environment with a young, international team of talented people to work with

Fulltime

Director, Data Management

The Associate Director / Director of Data Management is responsible for providin...

Location

United States , San Mateo

Salary:

Not provided

Dompé

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related discipline
12+ years of progressive experience in clinical data management, with at least 5 years in a leadership or oversight capacity
Extensive experience with Medidata products (Rave EDC, RTSM, Coder, integrations)
Proven ability to oversee multiple global studies and CROs concurrently
Deep understanding of clinical data management processes, data standards (CDASH, CDISC), and technology landscape
Experience in authoring and implementing SOPs, WIs, and operational best practices
Demonstrated success in supporting regulatory submissions (NDA, BLA, MAA) and managing inspection readiness
Strong leadership, problem-solving, and decision-making skills with the ability to operate independently
Excellent communication, organizational, and stakeholder management skills
Experience with budget forecasting, cost tracking, and resource planning for multi-study portfolios

Job Responsibility

Strategic Leadership & Oversight: Lead data management strategy across multiple studies and programs, ensuring alignment with corporate and regulatory objectives
Oversee CROs and external partners to ensure consistent quality, compliance, and timely delivery of study data
Act as the primary point of contact for data management oversight, providing direction, decision-making, and escalation management
Ensure study-level data standards, quality metrics, and processes are defined and consistently applied
Operational Excellence Across Study Lifecycle: Manage all data management activities from study start-up through database lock and close-out
Oversee development and execution of Data Management Plans (DMPs), edit check specifications, external data transfer agreements, and data validation activities
Ensure data collection systems, workflows, and integrations align with protocol requirements and regulatory expectations
Provide oversight for database design, User Acceptance Testing (UAT), and database release readiness
CRO & Vendor Management: Lead governance and performance management of CROs supporting data management functions
Review and approve study deliverables (CRFs, DMPs, edit checks, transfer specs, listings, and reconciliation plans)

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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