Clinical Supplies Project Coordinator Job at CK Group (Wirral)

Clinical Supplies Project Manager

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

Location

Poland , Warsaw; Gdansk

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree or equivalent, preferably in a scientific or pharmaceutical discipline
At least four (4) years of experience in clinical supplies
Working knowledge of the Clinical Trial Supply process
Working knowledge of project team structure and processes
Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution
Knowledge of project management and Clinical customer relationship building
Knowledge of the 'Customers' team structures and processes
Excellent verbal and written communication skills
Ability to influence others
Ability to multi-tasks

Job Responsibility

Manage clinical supply planning and forecasting for study protocols
Serve as member of clinical study team and/or clinical drug supply team, as assigned
Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
Support design and set-up of IRT system
Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
Coordinate the origination, proofing and translation of clinical study labels, as required
Monitor global clinical supply inventory at the clinical site level for both IRT and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
Serve as 'consultant' for managers throughout the organization on issues related to clinical supplies and project management

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 Supplies Project Manager

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

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree or equivalent, preferably in a scientific or pharmaceutical discipline
At least three 2-3 years of experience in clinical supplies planning/supply chain management, with (5) years of experience in clinical supplies, clinical research or pharmaceutical development
Working knowledge of the Clinical Trial Supply process
Working knowledge of project team structure and processes
Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
Knowledge of project management and Clinical customer relationship building
Knowledge of the ‘Customers’ team structures and processes
Excellent verbal and written communication skills
Ability to influence others
Ability to multi-tasks

Job Responsibility

Manage clinical supply planning and forecasting for study protocols
Serve as member of clinical study team and/or clinical drug supply team, as assigned
Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
Support design and set-up of IRT system
Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
Coordinate the origination, proofing and translation of clinical study labels, as required
Monitor global clinical supply inventory at the clinical site level for both IRT and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
Serve as ‘consultant’ for managers throughout the organization on issues related to clinical supplies and project management

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

Project Coordinator

We are looking for a dedicated Hybrid Project Coordinator to join our team on a ...

Location

United States , Palo Alto

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Bachelor’s degree preferred
Strong understanding of hospital and clinic organizational structures is advantageous
Excellent organizational skills with the ability to manage multiple tasks and priorities effectively
Ability to work independently and collaboratively within a team environment
Proficient in Microsoft Office Suite, including Excel, Word, and PowerPoint
Exceptional written and verbal communication skills to convey information clearly
Demonstrated ability to handle confidential information with discretion and good judgment
Proven leadership skills with experience in managing events and coordinating departmental activities

Job Responsibility

Manage project schedules and ensure all phases are documented and completed on time
Oversee financial management, inventory, and purchasing processes to optimize departmental resources
Coordinate hiring processes, conduct department orientations, and ensure compliance with HR policies and procedures
Facilitate inventory reviews and prepare reports for equipment and supply management
Organize and manage events, workshops, and committee meetings to support departmental goals
Serve as a liaison between customers, vendors, and internal departments to maintain positive relationships
Provide administrative support, ensuring smooth workflow and timely submission of required paperwork
Track and report cost management efforts, presenting findings during staff meetings
Identify opportunities for improvement and implement solutions to enhance departmental processes
Participate in assigned projects and complete tasks within established deadlines

What we offer

medical
vision
dental
life and disability insurance
eligible to enroll in our company 401(k) plan

Registered Nurse Clinical Coordinator Navigator Womens Health

Location

United States , Chicago

Salary:

35.50 - 53.25 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Graduate from accredited school of nursing
5+ years of nursing experience
BSN preferred
Leadership experience preferred
Knowledge of OSHA, FMLA, ADA, DOT regulations, CDC guidelines, Workman’s Comp Laws if applicable
Good communication skills
Proficient with keyboard and computers
Good time management and organizational skills
Current RN Licensure in State of Illinois
Current CPR certification

Job Responsibility

Participates in the delivery of quality clinical care
Works closely with healthcare team and physician to assure triage, telephone assessments, home therapies and patient visits are consistent with established guidelines and followed by the healthcare team
Takes a lead role with the clinical team to meet/exceed CI goals
Assists physicians and associates in managing patient registries
Performs clinical duties as determined by the needs of the practice site(s) or as assigned by his/her manager
Supports a safe environment for patients and associates through effective monitoring of staff compliance to established standards of care, policies and procedures and HIPAA compliance
Ensures associates are up-to-date with all safety training and certifications
Utilizes information to implement process changes and staff education
Leads and participates in site clinical integration activities
Identifies, evaluates, and resolves potential safety problems

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Registered Nurse Clinical Coordinator Navigator Womens Health

Location

United States , Chicago

Salary:

35.50 - 53.25 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Graduate from accredited school of nursing
5+ years of nursing experience
BSN preferred
Leadership experience preferred
Knowledge of OSHA, FMLA, ADA, DOT regulations, CDC guidelines, Workman’s Comp Laws if applicable
Good communication skills
Proficient with keyboard and computers
Good time management and organizational skills
Current RN Licensure in State of Illinois
Current CPR certification

Job Responsibility

Participates in the delivery of quality clinical care
Works closely with healthcare team and physician to assure triage, telephone assessments, home therapies and patient visits are consistent with established guidelines
Takes a lead role with the clinical team to meet/exceed CI goals
Assists physicians and associates in managing patient registries
Performs clinical duties as determined by the needs of the practice site(s) or as assigned by his/her manager
Supports a safe environment for patients and associates through effective monitoring of staff compliance to established standards of care, policies and procedures and HIPAA compliance
Ensures associates are up-to-date with all safety training and certifications
Utilizes information to implement process changes and staff education
Leads and participates in site clinical integration activities
Identifies, evaluates, and resolves potential safety problems

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Senior Clinical Materials Project Manager

Leads or coordinates cross-functional project/program teams from design to deliv...

Location

United States of America , Rochester

Salary:

63815.00 - 95723.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s Degree with major course works in appropriate health, social science, or biological science field required
Minimum 5-10 years of experience, or equivalent combination of education and experience required
Clinical trials project management experience preferred
Knowledge of Good Manufacturing Practices and Good Clinical Practices, planning, implementation, and coordination of clinical trials
Strong communication skills, including written communication
Strong presentation, interpersonal and organizational skills, and attention to detail
Travel required (up to 5%)

Job Responsibility

Leads or coordinates cross-functional project/program teams from design to delivery of fully-developed products that are ready for customer use
Monitors performance and recommends schedule changes, cost adjustments or resource additions
Investigates facts and develops solutions to problems during the design and planning phases
Provides timely and accurate information and status updates to functional leaders
May be responsible for feasibility studies, field trials management, identifying product gaps, defining product requirements and engaging with customers to understand market needs and trends
Directs and oversees the planning, implementation, coordination, and supply chain of clinical supplies to support multi-center clinical trials
Plans internal meetings and provides professional direction within the clinical materials service unit team
Develop and deliver training programs to support new processes and projects
Serves as liaison to study sponsors, clinical coordinating centers, data coordinating centers, clinical trial sites, pharmacy departments, contract research organizations, study principal investigators, study medical monitors, biostatistics department, and administration/fiscal unit
Drafts and develops the CMSU’s Clinical Materials Specifications Sheet (CMSS), processing orders, shipping instructions, packing lists/Acknowledgement of Receipts (AOR’s), and study drug handling instructions

Fulltime

Clinical Operations Senior Project Manager

The Clinical Operations Project Manager ensures the oversight of the activities ...

Location

United States , San Mateo

Salary:

147817.00 - 175014.00 USD / Year

Dompé

Expiration Date

Until further notice

Requirements

Bachelor’s/Master’s Degree in Pharmacology, Biotechnology or related scientific discipline
7-12 years of experience in similar roles, preferably in the Pharmaceutical/Life-science sector
Project Management Certification is preferred
Languages: Italian English (fluent)
Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office)
Knowledge of GCP/ICH phase I-IV clinical trials and observational studies
Knowledge of research and clinical trial methodologies
Knowledge of CRO industry
Knowledge of Project Management
Knowledge of Pharmaceutical sector

Job Responsibility

Supervises the CRO activities in all the study conduct phases (start-up, maintenance, study closure)
Is responsible to coordinate and drive in a functional matrix model the multidisciplinary team assigned to each of the company clinical trials
Is involved in the CRO process selection in compliance with current company SOPs
Is responsible for set-up and progress of the study according to the company current standards/regulation and ensures that committed targets are met until study completion
Collaborates with the local Medical Department and Site Engagement Manager to identify potential investigators to be included in the clinical network of Dompé
Collects and manages input to the study protocol and operational aspects of the study, participates in the planning of Investigator Meetings
Works with Local Drug Supply Management and ensures IMP is available to commence and complete assigned trial/assigned trial sites
Maintains knowledge of the study protocol to answer standard operational questions from CRAs of the CROs, sites, and internal Country/Cluster personnel
Ensures the performance of the CRO assigned to the study in order to be on time, budget and quality by collecting, analyzing and reporting detailed performance KPI dashboards
Closely collaborates in autonomy with the CRO project management team in order to ensure that anticipated study milestones and target are met and in order to put in place corrective or mitigation plans to address risks that may impact missing study objectives

What we offer

Comprehensive medical benefits
Generous vacation / holiday time off
Competitive 401(K) matching

Fulltime

Clinical Trial Associate

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BS/BA degree or degree in healthcare field required
Direct experience supporting clinical operations activities, 1+ years in pharma/biotech company or 2+ years of experience in a CRO
Very strong foundational understanding of clinical trials, and have prior experience in the administrative aspects of clinical operations
Experience managing the TMF with a solid understanding of filing expectations at study, country, and site levels
Experience managing the CTMS, study team lists, SharePoint accesses
Taking diligent meeting agendas/minutes
Tracking and following up on action items with a fundamental understanding what goes into each action
Tracking study plans & training compliance
Maintaining ongoing systemic reviews, such as User Access Reviews, eSystems List Reviews, Global Vendor Listing Reviews
Effective written and verbal communication skills, with the ability to work collaboratively within study teams

Job Responsibility

Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
Set up, organize and maintain study files and shared spaces in accordance with study requirements
Coordinate and track study training
Manage study sample and supply tracking and support interactions with vendors as needed
Support the Study Management team with specific projects
Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues
Perform routine quality checks on trial level documents to ensure completeness and accuracy
Supports the timely, complete and compliant archiving in the TMF

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Clinical Supplies Project Coordinator

Job Description

Job Responsibility

Requirements

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