Clinical Project Associate Job at canfield scientific

Clinical Research Associate II/Sr. Clinical Research Associate - 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

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
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner 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
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
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

What we offer

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

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

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

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
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
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication skills in German and English
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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

Clinical Research Project Associate

Clinical Research Project Associate - Monday - Friday (7:30 AM- 4:00 PM) - Great...

Location

United States , Lenexa

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Associates or BS degree, or equivalent experience with HS diploma/GED
Experience in an administrative capacity managing documentation and multiple systems, preferred
Proficiency in computerized information systems and standard application software, including MS Office
Strong skills in MS Word, PowerPoint, Excel, and Outlook, with experience in maintaining Excel trackers and building PowerPoint slides

Job Responsibility

Organize classify, index, file, retrieve and store records and documents in the document storage filing system
Overseeing internal and client project reporting, ensuring accuracy in reports for project status and financial tracking, along with system updates and queries
Ensure that material submitted for archiving corresponds to that described in chain of custody documentation
Maintain the documentation storage to ensure that it is organized and has a clear path to entry and exit and remains in compliance with SOPs
Support the project manager to facilitate sponsor audits by performing review of index file and providing notification of missing documents
Maintain the templates and forms used in support of document storage to ensure that they are current and readily accessible to project teams
Preparing and maintaining study files, ensuring compliance with filing/naming guidelines in the electronic trial master file, and tracking document status

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 Regulatory Affairs Associate - Clinical Trial Applications (CTA)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

Fulltime

Sr Associate Clinical Supply Chain Support Office

In this vital role, you will serve as Sr Associate, supporting the Design and Se...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

5+ Years of experience with Bachelors degree or equivalent in logistics, business administration or life science
Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry
Typically relevant working experience in an international and regulated environment
Understanding of fundamentals of logistics/supply chain principles (especially BOM)
Experience in planning
Experience in project management techniques
Advanced experience in MS Office applications (Word, Excel)
Fluency in English, both in oral and written communication
High quality standards with regards to work
Ability to set priorities and timely escalation

Job Responsibility

Serve as Sr Associate, supporting the Design and Setup of the Clinical Supply Chain
Managing master data requests for product materials, Bill of Materials (BOM), and study related attributes in SAP
Creation of the Clinical Artwork requests and facilitating prioritization of outstanding attributes in relation to the request form
Creation and maintenance of Product Specification Files, and Depot Plans
Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms
Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial
Creates and maintains third party depot plans and cross docks to support global study footprint
Maintains Metrics for Global Setup lead team
Contributes to monthly Workforce planning cycle

Fulltime

Sr Associate Clinical Supply Chain Support Office

In this vital role, you will serve as Sr Associate, supporting the Design and Se...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

5 Years of experience with Bachelor degree or equivalent in logistics, business administration or life science
Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry
Typically relevant working experience in an international and regulated environment
Understanding of fundamentals of logistics/supply chain principles (especially BOM)
Experience in planning
Experience in project management techniques
Advanced experience in MS Office applications (Word, Excel)
Fluency in English, both in oral and written communication
High quality standards with regards to work
Ability to set priorities and timely escalation

Job Responsibility

Master Data in ERP (SAP)
Initiate clinical label material requests
Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures timely availability to adhere to overall project timelines
Ensures setup of Study Design Tables
Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries
Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial
Creates and maintains third party depot plans and cross docks to support global study footprint
Maintains Metrics for Global Setup lead team
Contributes to monthly Workforce planning cycle

Fulltime

New

Clinical Project Manager - Early Phase Trials

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

Location

United States , Remote

Salary:

125000.00 - 138000.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

2 years of Project Management experience with Parexel or 3 to 5 years in related fields
Experience as a Functional Team Leader or in coordinating clinical trials
Knowledge of ICH-GCP and pharmaceutical industry regulations
Proficiency in MS-Office products
Bachelor’s degree in a science-related field or equivalent work experience

Job Responsibility

Lead cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
Own the sponsor relationship and manage sponsor communication
Serve as the central point of contact and escalation for functional teams
Proactively communicate project progress, risks, and solutions to sponsors and internal teams
Lead regular meetings with sponsors and project teams to ensure objectives are met
Review relevant materials and attend strategy meetings
Prepare for Bid Defense and develop project management strategies
Attend Bid Defense and handover meetings

What we offer

Annual performance-based bonus plan
Annual salary review
Additional total rewards incentives
Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings in accordance with the terms of applicable plans

Fulltime

New

Senior Associate Clinical Pricing & Payments

Investigator Pricing Analyst Home based Spain, UK and other countries! ICON plc ...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

3-5 years’ work experience in financial support or contract administration role
BA/BS/BSc in Finance or Accounting

Job Responsibility

Support Global Development Operations, Global Study and Clinical Management Groups and Therapeutic Area Teams by creation of pricing proposals for clinical study budgets, consulting and related agreements
Support Finance in the development of study level budget estimates using pricing tools
Development of fair market value negotiation guidelines for each pricing request
Maintain database of information related to pricing
Ownership of pricing tools and templates/forms
Participating in team/department special projects as required
Receive pricing requests from Clinical Development Study Clients for original or amended budgets
Review study protocol or consulting scope of work and discuss with Clinical Study Team
Use industry benchmarking pricing tool(s) and internal historical data to create base clinical study budget or recommendation for consultant or services compensation
Create budget spreadsheet and corresponding documentation to be incorporated into Agreement

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

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Clinical Project Associate

Job Description

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