Project Manager, IRT Job at iconplc (Reading)

Manager, CSAR - Global Library

The Global Library Manager will report to the Sr. Manager, Clinical System and A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience
Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience
Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience
Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
General project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
Good Clinical Practice knowledge
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Knowledge of drug development and clinical trials processes
Knowledge of data management processes

Job Responsibility

Support of clinical trial platform technologies
Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight
Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems
Coordinating and providing programming support to Clinical Study Teams
Maintaining standard business processes within GDO to ensure compliance to regulatory bodies
Acting as a technical point of contact for systems deliverables on defined programs
Providing technical and business process input / expertise on new and emerging technologies
Develop, review and implement policies, SOPs and associated documents
Assist in preparing for and responding to audit findings (internal or external)
Provide Global Library review at the study level

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Manager, Supply Chain Management

We are seeking a highly motivated and results-oriented Manager, Supply Chain Man...

Location

United States

Salary:

145000.00 - 165000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

S/M.S. Science or Engineering, or related fields with 5+ years of relevant experience in supply chain management
certification in Supply Chain Management or Project Management a plus
Experience with inventory and Supply Chain Management for complex global clinical trials
experience with upstream material management and device assembly are a plus
Knowledge of import/export requirements and significant experience with international clinical supply
Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
Proven ability to manage multiple projects, proactively identify and resolve issues using strong attention to detail and problem-solving skills
Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
Excellent communication and influencing skills, strong collaboration skills
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Maintain inventory oversight of applicable drug supply (Cell Banks (CB), Drug Substance (DS) and Drug Product (DP)) in collaboration with other functions in Development, Manufacturing & Supply (DMS)
Support logistics execution and oversight of DS and DP supply with other trade compliance activities as needed
Assist with assembly of bulk devices and allocation across studies as applicable
Develop and execute Demand & Operations Planning (D&OP) with Supply Chain Management team and other cross-functional members, such as Clinical Operations and Manufacturing
Utilize forecasting tools to develop clinical supply forecasts to enable supply planning per assigned studies and/or bulk supply across studies
Develop packaging and supply strategies to meet clinical study needs, maximize supply efficiency, and minimize waste while maintaining a low risk profile
Clearly communicate expiry requirements based on labeling strategy and supply plans with Analytical Development
Represent Apogee with selected external providers to develop project requirements and provide project management oversight during planning and execution
Manage oversight of packaging and labeling jobs for assigned studies in collaboration with GMP Quality Assurance
Develop requests for proposals for labeling, packaging, storage, and distribution

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Director, IRT Systems

The Director, IRT Systems will be responsible for the initiation, execution, mai...

Location

United States , Waltham

Salary:

196000.00 - 240000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience managing end-to-end activities for IRT system builds and close outs
Ability to interpret clinical protocols and provide system-based solutions for IRT optimization
Profound knowledge of various drug presentations and formulations
Excellent project management and organizational skills
Excellent communication skills and ability to present and articulate system needs clearly and effectively
Successful management and deployment of kit list builds (Dummy and Live) across Ph I – Ph III clinical studies for both open label and blinded needs
Ability to work cross-functionally and prioritize activities while maintaining all requisite timelines for study needs
Thrive in a fast-paced environment
Passion for continuous improvement and innovation to bring study drug to patients quickly and effectively
Bachelor's degree or equivalent experience

Job Responsibility

Liaison between Global Supply Chain and Business Operations to gather requirements and timing for quotes through go live dates
Expert in interpreting protocols and study schemes to ensure IRT builds are properly quoted and executed
IRT system design and overnight including management of study drug kit lists (Dummy and Live)
Collaborates cross functionally with clinical development, clinical operations, CMC, and statistics, focusing on randomization schema, stratification, and site & subject management, to ensure all requirements across the groups are met within the system
Vendor management: Serves as primary contact for IRT vendors internally and escalates requests and support as needed
Leads project documentation, test scripts, eTMF filing and performance metrics from study start to closeout for company portfolio
Risk management and continuous improvement to ensure IRT is performing as needed
Supports day to day activities for ad hoc resolutions, process optimizations and enhancements as needed
Actively participates in clinical study meetings, provide updates on system functionality and provides training as needed
Proactively reviews requirements to identify potential risks and build risk mitigation strategies

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Director, Global Supply Chain

The Director, Global Supply Chain reports to the Senior Director, Global Supply ...

Location

United States , Waltham, MA or San Diego, CA

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
8+ years of experience in clinical supply management
Experience with global pharmaceutical development and manufacturing operations for development-stage and/or commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
Deep understanding of IRT systems
Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Domestic or international travel is required (up to 20%)

Job Responsibility

Managing drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
Providing day-to-day oversight of packaging and labeling/distribution vendors, including relationship management
Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify management in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

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

Regional Product Service Manager

The Regional Product Service Manager (RPSM) is responsible for ensuring service ...

Location

Bulgaria , Sofia

Salary:

Not provided

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

Lead services on product or solution Extended Integrated Readiness Team (X-IRT)
Provide service requirements into product development stages/phases
Represent Regional Support Services Delivery, Professional Services Delivery and Managed Services in Integrated Readiness Team (IRT)
Work across countries, clusters and WW teams to develop the plan and lead the implementation of end-to-end delivery readiness
Perform business analysis, identify root cause, and develop recommendations/solutions to drive business improvements
Utilize in-depth understanding of customer business and complex requirements to develop business case
Lead complex cross functional activities that drive continuous growth of the business
Provide solution to fill gap between NPI/NSI strategy and the geo requirements
Provide mentoring and guidance to peers and lower-level employees
Multi country responsibility / a large country with multiple sub geos

Job Responsibility

Ensure service and support readiness for New Product Introductions (NPI) and New Service Introductions (NSI)
Represent Regional Delivery
Engage with DR Corporate Product Service Managers (CPSMs) on each NXI project
Lead team of regional based delivery representatives
Prepare HPE Operations delivery teams to support product and services launches
Provide NPI/NSI sustaining phase support to regional and country delivery teams through EOSL
Lead to develop region delivery readiness activities and plans for HPE direct workforce, Sub-contractors and Variable Workforce
Establish alignment among HPE support delivery operation and enablement teams
Implement and monitor service delivery readiness activities
Define tracking and reporting requirement of readiness progress, resource status

What we offer

Health & Wellbeing benefits
Personal & Professional Development programs
Unconditional Inclusion environment
Comprehensive suite of benefits supporting physical, financial and emotional wellbeing
Career development programs
Access to broad portfolio of HPE technologies
Global network of partners and customers

Fulltime

Lead Commissioner

The role of Lead Commissioner directly supports the company’s mission to develop...

Location

United States

Salary:

38.00 - 40.00 CAD / Hour

Nordex Group

Expiration Date

Until further notice

Requirements

Associate’s in electrical engineering or technical degree in wind energy preferred
equivalent related work experience and training in the wind industry acceptable
Minimum of 3 years’ experience in Wind Turbine Commissioner role or similar
Minimum 2 years’ WTG commissioning experience required
Knowledge of the mechanical, electrical, hydraulic, fiber optics, their function, and repair wind turbines Nordex and Acciona technologies
Competent in switching various types of switchgear
Strong leadership, communication, organizing, and troubleshooting skills
Ability to prioritize work, multi-task efficiently, meet deadline obligations, prepare reports, and outline what is best practice
Commit to Safety, Quality, and Environmental standards
Have a strong code of ethics and integrity

Job Responsibility

Schedules of daily work activities for Nordex and subcontractor Commissioners and track progress
Provides field support when issues arise, provides technical knowledge about procedures and troubleshooting
Audits the work being done at the Turbines to ensure the customer receives a quality product
Ensure all spare parts are accounted for and NC’s are written as necessary, cycle counts are accurate and order parts if needed
Tracks monthly inventories of Technician tooling, PPE, and Vehicle inspections
Assists Site and Quality Assurance management as needed
Prepares reports and progress trackers for commissioning activities to various departments
Ensures all Health, Safety, and Environmental guidelines are met and enforced, training and certifications are up to date
Provides Service with Post-Sales support with the installation of IRT’s, LBA’s, troubleshooting, and component replacement if necessary
De-Mobilizes Conexs and personnel at the completion of the project

What we offer

Paid Time Off - Three (3) weeks accrued (120 hours)
Medical & Pharmacy Insurance with multiple options to best meet your needs
Health Savings Account (HSA) with Employer Contribution
Flex Spending Account (FSA)
Dental Insurance
Vision Insurance
Short-Term / Long-Term Disability Insurance
Life and AD&D Insurance
401(k) with Employer Match
Student Debt Repayment

Fulltime

Lead Commissioner

The role of Lead Commissioner directly supports the company’s mission to develop...

Location

United States

Salary:

38.00 - 40.00 CAD / Hour

Nordex Group

Expiration Date

Until further notice

Requirements

Associate’s in electrical engineering or technical degree in wind energy preferred
equivalent related work experience and training in the wind industry acceptable
Minimum of 3 years’ experience in Wind Turbine Commissioner role or similar
Minimum 2 years’ WTG commissioning experience required
Knowledge of the mechanical, electrical, hydraulic, fiber optics, their function, and repair wind turbines Nordex and Acciona technologies
Competent in switching various types of switchgear
Strong leadership, communication, organizing, and troubleshooting skills
Ability to prioritize work, multi-task efficiently, meet deadline obligations, prepare reports, and outline what is best practice
Commit to Safety, Quality, and Environmental standards
Have a strong code of ethics and integrity

Job Responsibility

Schedules of daily work activities for Nordex and subcontractor Commissioners and track progress
Provides field support when issues arise, provides technical knowledge about procedures and troubleshooting
Audits the work being done at the Turbines to ensure the customer receives a quality product
Ensure all spare parts are accounted for and NC’s are written as necessary, cycle counts are accurate and order parts if needed
Tracks monthly inventories of Technician tooling, PPE, and Vehicle inspections
Assists Site and Quality Assurance management as needed
Prepares reports and progress trackers for commissioning activities to various departments
Ensures all Health, Safety, and Environmental guidelines are met and enforced, training and certifications are up to date
Provides Service with Post-Sales support with the installation of IRT’s, LBA’s, troubleshooting, and component replacement if necessary
De-Mobilizes Conexs and personnel at the completion of the project

What we offer

Paid Time Off - Three (3) weeks accrued (120 hours)
Medical & Pharmacy Insurance with multiple options to best meet your needs
Health Savings Account (HSA) with Employer Contribution
Flex Spending Account (FSA)
Dental Insurance
Vision Insurance
Short-Term / Long-Term Disability Insurance
Life and AD&D Insurance
401(k) with Employer Match
Student Debt Repayment

Fulltime

Project Manager, IRT

iconplc

Location:
United Kingdom , Reading

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
May 05, 2026

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