Clinical Trial Supply Manager Job at Astek (Brussels)

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

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

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

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

Clinical Trials Assistant - FSP

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

Australia , North Ryde, Sydney, Macquarie Park

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Adaptable
Communicator
Collaborative
Leadership
Proactive
Problem-solver

Job Responsibility

Clinical trial related general tasks as required throughout the trial life cycle
Communicate internally with clinical trial team (e.g., CTM, CRA) and externally with clinical sites, vendors and other departments
Set up and maintenance of trial related sharing platforms e.g., Sharepoint Online
Support trial document management processes for Clinical Documentation System (Veeva Clinical, Clinergize etc) including TDS communication of document event date, document submission, quality check/resolution and set up & maintenance of paper TMF documentation/filing and arrangement of long-term archiving process if required
Coordinate clinical trial related document translation process
Support trial related documents verification
Support trial document creation & filing process e.g., local clinical trial protocol amendment, local signature page etc.
Support CTM for the site ISF archival, if locally required to use external archiving vendor
Support RA/EC submission e.g., CTR relevant as applicable
Support updates of clinical trial related information into Clinical Trial Management System (e.g., Veeva Clinical)

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Remote, in-office and hybrid roles
Varied project experience
Career progression

Junior Clinical Trial Manager

At Parexel FSP people make the difference. We have a crucial mission: to prevent...

Location

Spain

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
Strong experience as CRA and Lead CRA
Strong experience of data management and query resolution in clinical trials
Overall knowledge of site management and monitoring procedures
Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
Degree in the life sciences field preferred

Job Responsibility

Manage external vendors and contract research organizations
Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
Assist with protocol development and study report completion
Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
Provide guidance, direction, and management to CRAs
Track patient enrollment
qualify, initiate, monitor, perform closeout activities, and review site reports
and assist in coordination of data management activities
Coordinate study supplies

What we offer

Exceptional financial rewards, training, and development
Healthy work-life balance

Clinical Supplies Manager

This vacancy has now expired. Please click here to view live vacancies. Home Bas...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, such as pharmacy, life sciences, or supply chain management
Proven experience in clinical supplies project management within the pharmaceutical or biotech industry
Strong understanding of regulatory requirements related to clinical trial supply management
Excellent organizational and communication skills, with the ability to guide cross-functional teams and drive project success
Problem-solving mindset, with the ability to adapt to changing project dynamics and implement effective solutions

Job Responsibility

Oversee the planning and execution of clinical supplies projects, ensuring timely delivery and compliance with regulatory requirements
Collaborate with cross-functional teams to design and implement effective strategies for clinical trial supply management
Monitor and analyze project timelines, budgets, and resource allocations to optimize efficiency and meet project goals
Address potential risks and challenges in clinical supplies logistics, proposing and implementing solutions to ensure smooth project execution
Foster strong relationships with internal and external stakeholders, facilitating effective communication and collaboration throughout the project lifecycle

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 Project Associate

An ideal candidate for our Clinical Project Associate position is an individual ...

Location

Salary:

23.00 - 28.00 USD / Hour

canfield scientific

Expiration Date

Until further notice

Requirements

Associate degree or at least 1 year work experience
Proficiency in Microsoft Office
Strong time management, problem-solving, and organizational skills
Ability to adjust to shifting priorities and meet timelines
Detail oriented, flexible, and works well within a team environment

Job Responsibility

Provide project management and operational support to designated clinical project team ensuring that quality, timelines, and project specifications are met
Manage study documentation ensuring accuracy within the documentation while aiding in the preparation of supply shipments to study sites
Setup, maintain, and update databases and assist with data query resolution
Perform quality control checks to ensure the integrity of data and may support initiation phase of project
Communicate with study sites by fielding, answering, and directing questions to obtain information and direct to corresponding personnel

What we offer

Paid days off
Medical, dental, and vision insurance
May be eligible for a discretionary bonus
401(k) plan with employer match (currently set at 50%)

Fulltime

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Clinical Trial Supply Manager

Job Description

Job Responsibility

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