Clinical Supplies Project Manager Job at iconplc (Warsaw)

Senior Clinical Supplies Project Manager

Senior Clinical Supplies Project Manager ICON plc is a world-leading healthcare ...

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

3 - 4 years experience of working within a Clinical Supplies Project Management role
Degree ideal
Open to office, remote or hybrid working

Job Responsibility

Provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, Manufacturing and Control (CMC) activities associated with them
act as the lead on appropriate project teams
Manage global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of our clients
Oversee labelling, packaging and distribution activities of CMO including review and approval of labelling/packaging records and distribution plans
Oversee recall, returns and destruction activities, as appropriate
Oversee the procurement of marketed drug product, such as comparators performed by an approved vendor and ensuring together with GRA/SSU that all study specific regulatory requirements are met
Perform Batch Record Review and Approval, as applicable
Manage temperature deviation, product complaints and recalls, as delegated by the client
Gap analysis of processes relating to pharmaceutical supplies for applicable project teams
Participates in the discussions of objectives and scope of prospective projects with potential clients

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

Clinical Project Manager - Post Trial Access

As a Project Manager - Post Trial Access at ICON, you will be responsible for le...

Location

Poland , Gdansk

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience in clinical research or biopharmaceutical operations
including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval
comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
Proven experience collaborating effectively
influencing stakeholders across functions and levels
Evidence of strong project management skills
including managing competing priorities and solving operational challenges in clinical or investigational program environments
Successful history of working independently in a global environment

Job Responsibility

Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders
with support as needed
Ensure alignment across PTA program decisions, documentation, plans, and implementation
Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
Manage vendor contracting and deliverables in support of PTA/continued access program execution

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 Supplies Manager

This vacancy has now expired. Please click here to view live vacancies. Home Bas...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, such as pharmacy, life sciences, or supply chain management
Proven experience in clinical supplies project management within the pharmaceutical or biotech industry
Strong understanding of regulatory requirements related to clinical trial supply management
Excellent organizational and communication skills, with the ability to guide cross-functional teams and drive project success
Problem-solving mindset, with the ability to adapt to changing project dynamics and implement effective solutions

Job Responsibility

Oversee the planning and execution of clinical supplies projects, ensuring timely delivery and compliance with regulatory requirements
Collaborate with cross-functional teams to design and implement effective strategies for clinical trial supply management
Monitor and analyze project timelines, budgets, and resource allocations to optimize efficiency and meet project goals
Address potential risks and challenges in clinical supplies logistics, proposing and implementing solutions to ensure smooth project execution
Foster strong relationships with internal and external stakeholders, facilitating effective communication and collaboration throughout the project lifecycle

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 Supplies Project Coordinator

CK Group are recruiting for a Clinical Supplies Project Coordinator to join a gl...

Location

United Kingdom , Wirral

Salary:

20.18 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Hold a relevant degree in a scientific subject, or have equivalent working experience
Knowledge of and ability to understand/implement regulatory and CGMP principles
Knowledge of ERP/MRP systems and supply chain principles
Strong project management skills
Experience in the pharmaceutical industry or related healthcare environment

Job Responsibility

Supports the delivery of clinical supplies through effective management of assigned projects
Generates, reviews and approves internal and external packaging and labelling production orders in accordance with the clinical trial design and product specifications
Reviews and approves vendor-generated production orders
Ensures CGMP compliance of activities in assigned areas of responsibility
Authors new and/or reviews existing procedural documents

Fulltime

Senior Manager, Clinical Supplies Management

An experienced clinical supply professional responsible for planning, coordinati...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

B.A./B.S., M.S., or Ph.D. in a technical concentration or other life sciences
A minimum of 8 years relevant experience
Expert in clinical supply planning/operations and vendor management
Excellent communication, collaboration, problem solving, and strategic thinking skills
Experienced in working within databases, systems, spreadsheets, and using presentation tools
Professional presence and keen insight regarding pharmaceutical development activities and inter-relationships between activities and systems
Process orientation
Resourceful and operationally oriented with ability to lead staff
Ability to develop and critically analyze technical documentation
Experience in the application and interpretation of cGMP, GCP requirements to pharmaceutical development processes and issues that arise

Job Responsibility

Provides clinical supply and product expertise to project teams and develops compound/drug related planning documentation and R&D protocol reviews
Proactively initiates discussion of plans with clinical and technical teams
Independently develops packaging and labeling documentation and Astellas system documentation with first-pass approval quality
Monitors international inventory and shipping trends for efficiency
Monitors packaging activities and department processes and outlines and proposes innovations for continual improvement
Supports staff development through demonstration and training
Serves as a consultative resource in the review of staff documentation and provides guidance
Establishes and monitors project budgetary spend
Remains current with industry practice, new processes, global Astellas business practice, and emerging Regulatory requirements and is responsible for raising awareness and educating the group on an ongoing basis

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

Supply & Logistics Project Manager in Clinical Trials

Are you ready to lead impactful projects ensuring secure, timely patient treatme...

Location

Poland , Warsaw

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Strong understanding of GxP regulatory framework
Extensive pharmaceutical/clinical research/biotech industry experience
Proven expertise in laboratory and/or clinical trial supply chain management
Excellent project management and operational leadership skills
Client-focused approach with strong business acumen
Financial management and negotiation abilities
Team mentorship and stakeholder management skills
Bachelor's degree in biology, pharmacy, health sciences, business administration, or equivalent experience
Fluent English (written and spoken)

Job Responsibility

Develop and execute supply strategies for IMP/NIMP, ANS, and laboratory samples
Ensure GLP, GDP, GMP compliance across all participating countries
Manage project timelines, budgets, and operational resources
Oversee third-party providers and negotiate contracts
Conduct risk assessments and develop mitigation plans
Serve as regulatory point of contact and resolve client issues
Lead process improvements and system optimization

What we offer

Benefits vary by country, but Parexel is passionate about our team’s overall wellness
Career Advancement
Talent Community

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

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Clinical Supplies Project Manager

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