Trial Supplies Manager Job at CK Group

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

Ctsu Trial Manager

Our subsidiary Randstad professional solutions is currently offering an attracti...

Location

Germany , Biberach an der Riß

Salary:

60000.00 - 70000.00 EUR / Year

Randstad

Expiration Date

Until further notice

Requirements

Master's degree in natural sciences or similar disciplines or completed vocational training with experience in clinical trials
Several years experiences in clinical trial supplies or related business
Experience in working in an international environment, as well as team leading and project management experiences
Ideally good knowledge and understanding of the regulatory and GMP/GCP requirements for IMPs
Ability to interpret complex project requirements
Good software skills (MS-Office)
German language skills, written and spoken
Fluency in written and spoken English
Strong problem solving capabilities with the willingness to make decisions and the ability to drive results
Very good communication, negotiation and presentation skills

What we offer

Fair compensation
Personal support

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Director, Global Supply Chain

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

Location

United States , Waltham

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
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Logistics Specialist

Logistics Specialist - Kiev, Ukraine - Office-based. ICON plc is a world-leading...

Location

Ukraine , Kiev

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Higher education
Bachelor’s degree in Pharmacy is desirable
Proven experience in logistics coordination or customer service, preferably in a clinical or pharmaceutical environment
Strong organizational and problem-solving skills, with the ability to manage multiple priorities
Excellent communication and collaboration skills to work effectively with internal and external stakeholders
Proficiency in logistics software and data analysis tools
Good command of MS excel
1C Warehouse Management System knowledge - would be a plus

Job Responsibility

Coordinating and overseeing the shipment, delivery, and storage of clinical trial materials
Received orders and performs booking of products in Warehouse Management System
Physically handles incoming/outgoing shipments and returns
Tracks shipments until delivery
Communicates information in a timely manner to relevant teams/clients
Maintains logistics and study related records
Provides reports to management
Participates in inventory counts

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

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

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 Associate

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills

Job Responsibility

Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list

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 maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Trial Supplies Manager

CK Group

Location:
United Kingdom

Category:
Pharmacy

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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