Clinical Trial Supply Manager Job at Astek (Brussels)

Supply Chain Manager For Clinical Trial Medications

In this role you will project manage the design, plan, and set-up of the study s...

Location

Sweden , Mölndal

Salary:

Not provided

Randstad

Expiration Date

Until further notice

Requirements

Masters or equivalent
fast learner
self-driven
comfortable working in a high pace R&D environment
collaborative team player
flexible
strong communication, planning and problem-solving skills
strong influencing, negotiating and problem-solving skills across geographical and cultural boundaries
ability to adapt and operate in bespoke multiple systems

Job Responsibility

Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply
Ensure effective communication with project teams and key partners across a global network
Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies
Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction
Manage the Interactive Response Technology (IRT) system to execute demand and supply planning
Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls

What we offer

competitive salary
benefits
collective agreements
large network
many social activities

Fulltime

Manager, Clinical Supply Chain

Proclinical is seeking a Manager, Clinical Supply Chain to oversee and execute c...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific field, Supply Chain Management, or a related discipline
Hands-on experience in global clinical supply chain management, including packaging, labeling, inventory, and distribution
Strong understanding of clinical trial operations and the drug development lifecycle
Foundational knowledge of GMP, GxP, GCP, and global regulatory requirements (e.g., FDA, EU)
Proficiency with systems and tools such as IRT/IXRS, inventory systems, Excel, Smartsheet, and ERP platforms
Expertise in risk identification, assessment, and mitigation strategies
Experience managing multiple studies/programs and overseeing vendors, CMOs, and CROs
Budget tracking, cost control, and financial oversight of clinical protocols
Strong problem-solving and decision-making skills with a risk-based approach
Proficient in MS Office tools, including Excel, PowerPoint, Visio, and Project

Job Responsibility

Manage end-to-end clinical supply chain activities, including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout
Ensure timely and complete achievement of protocol milestones, such as FPI, SIV readiness, and on-time site/patient deliveries
Collaborate with Clinical Operations, QA, Regulatory, and CMOs to ensure efficient and compliant execution
Identify, escalate, and mitigate risks related to delays, deviations, and supply disruptions
Oversee temperature excursions and supply deviations, ensuring proper documentation and resolution
Maintain compliance and inspection readiness across all execution activities
Monitor inventory levels and supply availability across programs
Contribute to process improvements, tools, and ways of working within the clinical supply chain
Train and mentor other trial leads to enhance team capabilities

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

Clinical Trial Manager

We are seeking a hands-on Clinical Trial Manager to oversee clinical trial opera...

Location

United States , Basking Ridge

Salary:

100.00 - 120.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

5+ years of clinical trial coordination/management experience
Global clinical trial experience required
Strong understanding of drug development processes
Strong project management and organizational skills
In-depth knowledge of FDA and ICH GCP guidelines
Excellent communication and stakeholder management abilities
Proactive, hands-on approach with willingness to wear multiple hats
Previous clinical monitoring experience
Experience with Microsoft PowerPoint
Bachelor’s degree in a science or clinical-related field required

Job Responsibility

Reviews, and may also contribute to the development of, clinical study-related documents
Helps to ensure that the study is conducted in accordance with agreed upon timelines
Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study
Contributes to the planning and coordination of investigator meetings
Maintains relationships with assigned investigator sites, vendors and consultants
Ensures investigator and investigator site personnel comply with protocols
Assists in the oversight of the shipment of, and return of, clinical supplies
Maintains accurate and updated study files
Participates in the selection and oversight of external service providers
Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency

What we offer

Medical
dental
401(k)
direct deposit
commuter benefits

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

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 Supply Chain Manager

Responsible for the end-to-end management of Investigational Medicinal Product (...

Location

Canada , Vancouver

Salary:

124560.00 - 155700.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Demonstrated expertise in cGMP, GCP, and global clinical trial regulations (e.g., FDA, EMA)
Experience managing packaging, labeling, and distribution partners (CMOs and all external partner organizations)
Bachelor’s degree in a scientific discipline, Supply Chain Management, or a related field, plus 8+ years of relevant work experience in the pharmaceutical or biotechnology industry, with at least 3 years in a direct clinical supply chain role
Hands-on experience with Interactive Response Technology (IRT/IXRS) systems is essential
Proven ability to manage complex, temperature-controlled (cold chain) logistics

Job Responsibility

Developing and maintaining global supply plans for clinical trials, including demand planning forecasts across AbCellera’s programs
Managing and maintaining global inventory across all central depots and clinical sites, ensuring uninterrupted supply while utilizing ERP/inventory systems for accurate record keeping
Managing packaging, labelling, and distribution activities with CMO partners
Coordinating global shipments of clinical supplies, ensuring strict compliance with international trade regulations, import/export requirements, and customs documentation
Managing and qualifying temperature-controlled shipments (cold chain), collaborating with Quality Assurance to resolve any temperature excursions
Collaborating with teams and vendors to set up, manage and lead User Acceptance Testing (UAT) for Interactive Response Technology (IRT/IXRS) systems governing inventory, randomization, and drug assignment
Ensuring all clinical supply activities strictly adhere to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and global regulations
Acting as the Clinical Supply Subject Matter Expert on clinical study teams, collaborating with CMC, Regulatory Affairs (label approvals/submission requirements), and Clinical Operations
Overseeing drug accountability, returns, and destruction, ensuring complete documentation, and assisting in the developing and managing of the clinical supply budget for assigned studies

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

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

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Clinical Trial Supply Manager

Job Description

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