Senior Clinical Supplies Project Manager Job at iconplc (Reading)

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 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

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

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

Senior Project Manager

As a Senior Project Manager, Laboratory at ICON, you will design and analyse cli...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences or healthcare
Previous experience in project management within a laboratory or clinical research setting
Strong leadership skills with the ability to mentor and train junior PMs
Excellent communication and interpersonal skills, with the ability to represent the company at client meetings and internal meetings
Detail-oriented with strong organizational skills to effectively manage study documentation, timelines, and budgets
Willingness to travel as required (approximately 20%)
Minimum of 5 years of experience in a clinical laboratory, clinical trials, or customer management role in a life science related organization
Minimum of 3 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical supply packaging and distribution, medical imaging, data management

Job Responsibility

Ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories' (ICL) services, including the setup and day-to-day management of studies
Attend and represent ICL at Client meetings
Manage studies in accordance with Good Clinical Practice
Provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner
Represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON
Act as the sponsor’s main contact person in all matters regarding our central laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON Site Services Department
Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Central Laboratories (and ICON Clinical CRO if appropriate)
Enter protocol parameter information into PACS//ICOLIMS and other systems for new and/or amended protocols. Prepare and review clinical study specific materials. When possible, coordinate with other departments for the preparation of study specific materials
Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained and filed
Monitor study progress throughout the study, using ICON tools and communicate pertinent information to clients/sponsors. Provide Sponsors with study management reports. Provide client with support on ICO Labs system. Inform team leader about study progress. Escalate issues of potential client/site dissatisfaction to appropriate 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 Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

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Senior Clinical Supplies Project Manager

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