Senior Local Trial Manager - Oncology Job at iconplc (Blue Bell)

Senior Clinical Trial Manager

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

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
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
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

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
Manages and oversees Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles, including support with transitions
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Managers (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs)
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL)
Country level ad hoc meetings during any phase of the study
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks

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

Fulltime

Senior Clinical Trial Manager

Senior Local Operations Manager - Hematology Oncology - Home Based. ICON plc is ...

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
Hematology 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
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
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
Contribute to site level recruitment strategy and contingency planning and implementation
Delivers competent vendor management at the country level to support the study
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
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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

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

Senior Manager, Site Engagement, Sponsor Dedicated

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

Location

United States , LOS ANGELES, COLORADO, CALIFORNIA, ARIZONA, WASHINGTON

Salary:

133736.00 - 167170.00 USD / Year

iconplc

Expiration Date

Until further notice

Requirements

Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development
Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
Oncology and/or Neurology and/or Immunology TA experience desired
Substantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct
Strong communication skills (verbal, written and listening) in both native language and English
Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
Ensuring compliance with applicable T&E Policy requirements
Role requires domestic and international travel up to 50% of time
Ability to work independently on assigned tasks or projects of increasing complexity
Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit

Job Responsibility

Establish and manage site relationships
Act as liaison between the company and investigational sites, building investigator and site staff awareness on client compounds
Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
Independently perform activities associated with the evaluation of investigational sites to build company network
Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
Develop knowledge of site capabilities and past performance to assess their potential as participating sites in client clinical trials
Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholders
Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas
Support Site Agreement negotiations, including stand-alone and Master Site Agreements
Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those

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

Senior Clinical Research Associate (Oncology Experience Required)

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Minimum of 5 years' experience in CRO or Pharma trials environments
Experience in oncology trials and RECIST criteria is essential
Fluency in English is required
Proficiency in local language is required
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders

Job Responsibility

Ensuring regulatory, ICH-GCP and protocol compliance
Verifying the process of obtaining informed consent
Assessing factors that might affect subject safety and clinical data integrity
Conducting monitoring activities using different methods (e.g., on site and remote)
Conducting source document review and verification
Managing reporting of protocol deviations
Applying query resolution techniques
Performing Investigational Product (IP) inventory, reconciliation and review
Verifying IP dispensation and administration
Managing reporting of identified issues

Senior Clinical Research Associate (Oncology Experience Required) - UK (Remote) - FSP

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in oncology trials and RECIST criteria is essential
Minimum of 4 years' experience in CRO or Pharma trials environments is also essential
Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Networking and relationship building skills
Ability to communicate effectively and appropriately with internal and external stakeholders
Ability to adapt to changing technologies and processes
Excellent communication (verbal and written), presentation, and interpersonal skills
Identifies and builds effective relationships with investigator site staff and other stakeholders
Proficiency in local language is required
Fluency in English is required

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensuring regulatory, ICH-GCP and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
immediately communicates/escalates significant issues to the project team and develops action plans
Verifies the process of obtaining informed consent has been adequately performed and documented
Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity
Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations
Conducts source document review and verification of appropriate site source documents and medical records
Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
Manages reporting of protocol deviations and appropriate follow up

What we offer

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

Fulltime

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
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

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor 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

What we offer

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

Fulltime

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Senior Local Trial Manager - Oncology

Job Responsibility

Requirements

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