Country Clinical Trial Manager / Local Trial Manager Job at Parexel

Senior Local Trial Manager - Oncology

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Start-up & Database Locks/Cleaning experience preferred
Oncology Solid Tumor experience required
Specific therapeutic area experience may be required depending on the position
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English

Job Responsibility

Ensuring top-quality end-to-end trial delivery at a country level
Managing the consistency of Local Trial Management duties and processes
Serving as the country-level single point of contact on the study for internal partners
Managing and overseeing Central IRB and other local vendors
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers
Efficient communication with Clinical Trial Managers, Clinical Operations and Global Trial Leader
Country level ad hoc meetings during any phase of the study

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, among others

Fulltime

Local Trial Manager - Oncology/Hematology

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

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
2 years of local trial management or mutually agreed clinical trial experience
Start-up & Database Locks/Cleaning experience preferred
Oncology hematology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate

Job Responsibility

Accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes
Serve as the country-level single point of contact on the study for internal partners
Manage and oversee Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM)
Inspection Readiness and AQR at the country level
Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence
Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

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

Country Study Operations Manager I

The Study Operations Manager I (SOM I) has responsibilities for study and region...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expertise in the use of study and site dashboards and reporting tools
Detail oriented and possesses technical expertise
Ability to manage moderately complex processes
Risk identification and mitigation, strategic planning, and critical path analysis skills
Analytical and problem solving skills
Ability to adapt to changing technologies and processes, work independently and exercise own judgement
Supportive of an environment where innovation is standard, including developing ideas and taking appropriate risks to advance innovative processes
Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
Ability to operate in a matrix environment
Fluency in written and spoken English required

Job Responsibility

Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
May be responsible and accountable for, as designated by the GSM: Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)
Regional, country and study level recruitment strategy

Fulltime

Country Study Operations Manager - FSP

Parexel FSP is looking for multiple Country Study Operations Manager I! Candidat...

Location

Mexico

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's of Science or Bachelor's of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master's of Science or Master's of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred
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 Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings
Comprehensive knowledge of own discipline with good knowledge of other disciplines
Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
Demonstrated clinical research experience and/or study management/startup project manager experience

Job Responsibility

Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
May help guide the study management strategy by contributing local intelligence and providing accurate updates on delegated tasks to support establishment of critical path activities and risks
May independently take on activities with instruction provided as needed

What we offer

Benefits vary by country, but Parexel is passionate about our team's overall wellness

Fulltime

Clinical Trials Assistant - FSP

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

Australia , North Ryde, Sydney, Macquarie Park

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Adaptable
Communicator
Collaborative
Leadership
Proactive
Problem-solver

Job Responsibility

Clinical trial related general tasks as required throughout the trial life cycle
Communicate internally with clinical trial team (e.g., CTM, CRA) and externally with clinical sites, vendors and other departments
Set up and maintenance of trial related sharing platforms e.g., Sharepoint Online
Support trial document management processes for Clinical Documentation System (Veeva Clinical, Clinergize etc) including TDS communication of document event date, document submission, quality check/resolution and set up & maintenance of paper TMF documentation/filing and arrangement of long-term archiving process if required
Coordinate clinical trial related document translation process
Support trial related documents verification
Support trial document creation & filing process e.g., local clinical trial protocol amendment, local signature page etc.
Support CTM for the site ISF archival, if locally required to use external archiving vendor
Support RA/EC submission e.g., CTR relevant as applicable
Support updates of clinical trial related information into Clinical Trial Management System (e.g., Veeva Clinical)

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Remote, in-office and hybrid roles
Varied project experience
Career progression

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

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

Fulltime

New

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US) ICON plc is a wo...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team

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

New

Senior Clinical Trial Manager

Senior Local Operations Manager - Oncology - Home Based. ICON plc is a world-lea...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English
Good written and oral communication skills
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
Contribute to site level recruitment strategy and contingency planning and implementation
Delivers competent vendor management at the country level
Ensures high standards for study monitoring by conducting quality local trial team meetings

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
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Select Country

Country Clinical Trial Manager / Local Trial Manager

Job Description

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