Senior Manager, Clinical Supplies Management 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

Senior Manager Clinical Supply Chain

The Senior Manager, Clinical Supply Chain is a senior leadership role accountabl...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree in supply chain management, Engineering, Life Sciences, or Business Administration
advanced degree preferred
12+ years of progressive experience in supply chain, planning, or operations roles within the pharmaceutical or biotechnology industry
Deep understanding of GMP and GCP interfaces, regulatory requirements, and the complexities of managing investigational products
Proven success leading large, cross-functional organizations within a global, matrixed environment
Strong digital and systems acumen, with experience implementing or operating platforms such as SAP, Anaplan, or equivalent
Demonstrated expertise in end-to-end clinical supply chain management, planning, vendor management, and business performance management
Exceptional analytical, strategic thinking, and communication skills, with a proven ability to influence senior leaders and drive enterprise outcomes

Job Responsibility

Lead the Development Supply Chain execution team, with end-to-end accountability for clinical material demand execution, packaging order conversion, and global distribution
Provide strong people leadership and operational governance while driving continuous improvement across inventory management, purchase order execution, NPI readiness, and compliant execution of temperature-controlled and specialty shipping requirements
Execute clinical trial readiness, including master data, artwork, and documentation management, ensuring GMP-compliant execution across all clinical programs
Provide leadership oversight for change controls, deviations, and CAPAs, driving standardization, training, and inspection readiness across the clinical supply chain organization
Lead material master data initiation, order management, and execution support for clinical manufacturing and packaging operations
Ensure continuous manufacturing and packaging support through process order management, 24/7 material availability, and optimization of inventory and order execution efficiency
Lead clinical logistics and cold chain operations, including logistics service provider vendor management, depot network planning, and compliant shipping lane design
Oversee clinical customer service and distribution quality activities, including proof-of-receipt monitoring, temperature data review, investigational product reconciliation, and resolution of distribution-related quality events and service complaints

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US) ICON plc is a wo...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team

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 Sales Manager- Clinical Trials

This role is in support of Alcura, a business offering clinical trial supply and...

Location

United States , Columbus; Remote

Salary:

88700.00 - 126940.00 USD / Year

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent preferable, but career experience considered
Minimum 8 years of experience in business development and global customer relationship management, with a focus on the clinical trials sector
Proven track record of managing senior-level client relationships and driving revenue growth
Experience working with CROs, pharmaceutical and biotech companies in an international context
Familiarity with clinical supply logistics is a plus
Established network of decision-makers in the clinical trials sector, including CROs, pharmaceutical and biotech companies
Strong presenting and selling capabilities, with the ability to simplify complex concepts for diverse audiences
Excellent communication and presentation skills, with the ability to engage confidently with senior executives (C-Suite) and adapt to various cultural and organizational contexts
Self-motivated and tenacious, capable of working independently
High level of professional gravitas, diplomacy, and negotiation skills to build trust with clients and internal teams

Job Responsibility

Leverage an existing network of contacts and decision-makers in the clinical trials sector to generate new business opportunities
Promote US-based clinical trial services, including Packaging, Labelling, Storage, and Distribution (PLSD), Comparator medications, and ancillary sourcing
Develop and execute a strategic sales plan to establish presence in the US market, targeting CROs, pharmaceutical and biotech companies
Build and maintain strong relationships with senior-level stakeholders (C-Suite) to influence commercial opportunities and decision-making
Confidently present services and value proposition, demonstrating professional gravitas in all client interactions
Serve as the primary point of contact for US clients, ensuring seamless communication across global teams
Manage the entire sales cycle, from prospecting and lead generation to closing deals, while maintaining strong customer relationships
Lead client meetings, sales pitches, and quarterly business reviews, preparing agendas and consolidating input from internal teams
Work closely with sales peers and teams across Europe
Collaborate with commercial teams across affiliates to provide a comprehensive customer approach

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime

Senior Clinical Trial Manager

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading th...

Location

United States , Madison

Salary:

91000.00 - 155000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in the life sciences or field as outlined in the essential duties
5+ years of experience in clinical research
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
Experience writing, reviewing and editing protocols
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)

Job Responsibility

Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Develop plans for systems and materials required to support the efficient execution of clinical studies
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
Develop study budgets and is responsible for accurately forecasting and managing study expenses
Oversee site contracting and study budget management
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

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

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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Senior Manager, Clinical Supplies Management

Job Description

Job Responsibility

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