Trial Delivery Lead Job at iconplc (Blue Bell)

Site Monitoring Lead / Clinical Operations Lead

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Germany

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University (e.g., bachelor’s or comparable degree) in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities
Demonstrated scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution
Understand dimensions of trial complexity include protocol, patients, sites, countries, vendors

Job Responsibility

Accountable for authoring the monitoring risk assessments and plans
Ensuring sponsor oversight, trend analysis, signal detection and delivery of assigned trials
Contribute to the overall success and delivery of assigned clinical trials according to defined milestones and key performance indicators
Accountable for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned
Safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, sponsor obligations, ICH-GCP and applicable regulations and always ensure inspection readiness
Delivers a risk-based site monitoring approach and training for the trial
Accountable for the development of the operational Site Monitoring & Oversight plans
Develops and provides appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)
Monitors progress and oversees Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct, including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans
Coordinates timely cleaning and delivery of clinical trial data with Trial Team and countries

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

New

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

New

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Brazil

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Global Delivery Manager

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

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or related field
advanced degree preferred
Minimum of 5 years of experience in clinical research
1-2 years working as an Associate Project Manager within a CRO or Pharma setting
Vendor management experience
Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards
Well familiar with key systems used in clinical trial delivery
Experience in using Trial Master File industry accepted standard
Strong project management skills (preferably with analytical / financial skills) and good leadership skills
Excellent verbal and written communication in English

Job Responsibility

Support the coordination and management of clinical trials
Contributing to the design, analysis, and advancement of innovative treatments and therapies
Delivering the clinical study to time, cost and quality
Ensuring inspection readiness by taking an oversight over study eTMF completeness
Working on end-to-end operational study delivery activities, from study setup to study archival
Setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP)
Working cross-functionally, with internal and external partners, on clinical study management activities
Monitoring study conduct and progress, identifying, resolving and escalating risks/issues
Reviewing key clinical documents, including the Protocol and Informed Consent Forms
Leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.)

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
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

New

Clinical Supply Chain Logistics Manager

Talentmark is recruiting for a Clinical Supply Chain Logistics manager to join a...

Location

United Kingdom , Moreton, Wirral

Salary:

34.00 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (or equivalent) in Supply Chain, Life Sciences, Engineering, or a related field
Proven experience in clinical supply chain logistics operations, preferably in a global clinical trial environment
Strong hands-on experience with STO management, shipment execution, and issue resolution
Demonstrated ability to operate effectively in high-pressure, time-critical (hyper-care) environments
Excellent communication skills with the ability to interface across study teams, regions, and external partners
Strong organizational skills, attention to detail, and ability to manage multiple priorities simultaneously
Experience working with external partners (e.g., CMOs, depots, logistics providers) is strongly preferred

Job Responsibility

Provide day-to-day operational oversight of all logistics activities for assigned clinical supply programs, ensuring delivery of IMP
Act as the single point of contact (SPOC) for logistics-related activities for designated studies, working with Study Teams, Regional Delivery Leads (RDLs), Trial Supply Managers (TSMs), and external partners
Provide weekly status reporting, including STO health, shipment execution, risks, mitigations, and prioritization

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

Study Start Up Lead

Talentmark is recruiting for a Country Study Start Up Lead to join a company in ...

Location

United Kingdom , Welwyn Garden City

Salary:

Not provided

CK Group

Expiration Date

Until further notice

Requirements

Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent
Postgraduate degree or master’s degree highly desirable
Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
Strong experience with UK specific clinical start up systems including IRAS, CPMS & iCT and ARSAC
Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
Experience managing vendor/CRO relationships
Experience management site relationships and leading leading site set up through to site activation

Job Responsibility

Drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients
Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders
Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance
Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities)

Trial Delivery Lead

iconplc

Location:
United States , Blue Bell

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 25, 2026

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Trial Delivery Lead

iconplc

Location:United States , Blue Bell

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Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:March 25, 2026

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Job Posted:
March 25, 2026