Contract Clinical Trial Associate Job at Solomon Page (Basking Ridge)

Contract Senior Clinical Research Associate

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

Location

United States , Los Angeles

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or health-related field or an equivalent combination of education and clinical research experience, particularly in a study coordinator or nursing role
Minimum of 3 years independent monitoring
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
Ability to travel at least 80% of the time (international and domestic - fly and drive) and should possess a valid driver's license

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

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 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

Site Contract Associate Ii

Parexel are looking for a Site Contract Associate I to join our Site Contracts t...

Location

Serbia; Romania

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Fluent command of German and English (written and oral) is required in addition to the local language
Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
Some experience of working on contracts/agreements
Strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects
Excellent interpersonal, verbal and written communication skills
Strong problem-solving skills
Ability to successfully work in a “virtual” team environment
Must have strong analytical skills with the ability to create or interpret legal language and budgets
Maintain grace under pressure while displaying a high level of professionalism
Align internal and external resources to achieve objectives

Job Responsibility

Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc.
Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain
Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable)
Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP
Ensure the best interest of both clients and Parexel are met
Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties
Follow record maintenance and archival guidelines to ensure they are met
Develop and maintain positive relationships with clinical trial sites
Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives

Fulltime

Senior Associate Clinical Contracts & Budgets

Provide clinical site contracting services to clinical study teams to support st...

Location

Romania , Bucharest

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree
Relevant experience in Legal, Negotiation and/or Finance
Working in a global environment
Matrix environment
Knowledge of local contracting processes in applicable countries
Knowledge of local payment processes in applicable countries
Business English and local language

Job Responsibility

Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving)
Support site-related questions regarding invoice preparation with respect to submission of invoices in Amgen Payment System (eGPS)
Support resolution of contract issues
Support contracting with local GSO vendors
Maintain contract tracking in appropriate systems
Manage Confidential Disclosure Agreement process
Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
Ensure payments are made in accordance with contracts
Maintain payment data tracking in appropriate systems
Responsible for providing information for entry into systems

Fulltime

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

Clinical Trial Manager

At NBCD, we're looking for a Clinical Trial Manager (CTM) with a can-do attitude...

Location

Denmark , Søborg

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master’s degree in health sciences
experience with the operational requirements of GCP
high proficiency in English
strong communication skills
over 2 years of clinical trial experience in roles such as Clinical Trial Associate, Clinical Research Associate, International Trial Manager, Clinical Trial Manager, or similar
excellent coordination skills
ability to keep track, delegate, and prioritize tasks efficiently

Job Responsibility

Driving the planning and execution of clinical trials
operational management including study and site start-up, site management, and site closure
mentorship, training, and development of clinical research associates and staff
client communication managing projects, contracts, and budgets
regulatory compliance
quality assurance and safety
documentation and communication
problem solving
centralized monitoring compliance

What we offer

flexible work-life balance
possibility to work from home

Fulltime

Site Contract Associate

Due to a growing portfolio, we are currently looking for an experienced Site Con...

Location

United Kingdom , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience
Proficient with Excel and PowerPoint
Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety
Ability to prioritize and manage multiple tasks simultaneously

Job Responsibility

Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines
Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts
Oversee CRO and Functional Service Provider activities in regards to site CDAs
Collaborate and coordinate with cross-functional teams
R&D, Legal, Compliance, Procurement and Finance in executing contracts
Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting
Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes

Senior Clinical Associate

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

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills

Job Responsibility

Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list

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 maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

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Contract Clinical Trial Associate

Job Description

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