Senior Manager, Clinical Supplies Management Job at iconplc (Warsaw)

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

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Ability to work in an environment of remote collaborators
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials
Good analytical and problem-solving skills
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines

Job Responsibility

Contributes to the selection of potential investigators
Accountable for study start-up and regulatory maintenance (in some countries)
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Proactively identifies and ensures timely resolution to study-related issues
Updates CTMS and other systems with data from study sites

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process

Job Responsibility

Contributes to the selection of potential investigators
In some countries, as required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings, as applicable
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Shares information on patient recruitment and study site progress
Drives performance at the sites
Proactively identifies and ensures timely resolution to study-related issues

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Freelance Senior Clinical Research Associate

TFS HealthScience is a leading global, mid-size Contract Research Organization (...

Location

Salary:

Not provided

TFS HealthScience

Expiration Date

Until further notice

Requirements

Bachelor’s degree, preferably in life sciences or nursing, or equivalent
Minimum of 2 years of experience working as a CRA (in oncology)
Ability to work in a fast-paced environment with changing priorities
Understanding of basic medical terminology and science related to assigned drugs and therapeutic areas
Solid understanding of Good Clinical Practice (GCP) regulations and ICH guidelines
Ability to work independently and within a team/matrix organization
Excellent written and verbal communication skills
Strong organizational skills
Ability and willingness to travel

Job Responsibility

Monitor clinical trials on-site and remotely in accordance with TFS/client SOPs, FDA regulations, and GCP/ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy
generate queries to resolve data issues
Identify site problems or deficiencies and report them to management through trip reports, memos, and communication with the Project Manager or Lead CRA
Initiate corrective actions as directed by the supervisor
Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager
Participate in contract handling and negotiation under direction of the Lead CRA/Project Manager
Set up the Investigator Site File (ISF) and Study Master File (SMF), or support the CTA in doing so, and distribute materials to investigational sites
Collaborate with the study team on SMF maintenance
Order, ship, and reconcile clinical investigational supplies for study sites, if applicable

What we offer

competitive compensation package
comprehensive benefits
opportunity for personal and professional growth in a rewarding environment

Parttime

New

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 of Health and Wellness

Responsible for providing overall leadership and management of the health and we...

Location

United States , Huntington

Salary:

70000.00 - 80000.00 USD / Year

Dewolfe Place

Expiration Date

Until further notice

Requirements

Registered Nurse or Licensed Practical Nurse in good standing
Registered Nurse preferred
One (1) year in a nursing leadership role
Senior Living experience preferred
BSL Certification
Proficiency in computer skills, Microsoft Office and ability to learn new applications
Must demonstrate an interest in working with a senior population
Ability to communicate effectively speaking the primary language of the residents
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence

Job Responsibility

Ensures that community follows all federal, state, local laws and regulations as it pertains to clinical care
Responsible for collecting, analyzing, and reporting occurrence trends, and if necessary, develop/implement improvement plans
Partners with Administrator and other team members to analyze and maintain all resident and team member health safety
Partners with pharmacy consultant to provide optimal pharmaceutical services to residents
Responsible for clinical expertise of licensed nurses
Assists with educational presentations as assigned by administrator
Identifies ongoing needs and services of residents through the assessment/ Service Plan process including documentation for residents with a change in health care status
Responsible for overseeing the completion of the monthly updates and reporting any pertinent changes to the responsible party
Partners with other department coordinators to identify, review, and discuss potential change in service/medication levels if applicable
Ensures the resident’s service plan is updated as indicated by state regulations

What we offer

Medical, dental, vision, life and disability insurances
Paid time off
Paid holidays
401(k) plan with company match
Employee Assistance Program
Accident insurance policies

Fulltime

Director of Health and Wellness

Responsible for providing overall leadership and management of the health and we...

Location

United States , Crawfordsville

Salary:

74000.00 - 82000.00 USD / Year

Dewolfe Place

Expiration Date

Until further notice

Requirements

Registered Nurse or Licensed Practical Nurse in good standing
Registered Nurse preferred
One (1) year in a nursing leadership role
Senior Living experience preferred
BSL Certification
Proficiency in computer skills, Microsoft Office and ability to learn new applications
Must demonstrate an interest in working with a senior population
Ability to communicate effectively speaking the primary language of the residents
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence

Job Responsibility

Ensures that community follows all federal, state, local laws and regulations as it pertains to clinical care
Responsible for collecting, analyzing, and reporting occurrence trends, and if necessary, develop/implement improvement plans
Partners with Administrator and other team members to analyze and maintain all resident and team member health safety
Partners with pharmacy consultant to provide optimal pharmaceutical services to residents
Responsible for clinical expertise of licensed nurses
Assists with educational presentations as assigned by administrator
Identifies ongoing needs and services of residents through the assessment/ Service Plan process including documentation for residents with a change in health care status
Responsible for overseeing the completion of the monthly updates and reporting any pertinent changes to the responsible party
Partners with other department coordinators to identify, review, and discuss potential change in service/medication levels if applicable
Ensures the resident’s service plan is updated as indicated by state regulations

What we offer

medical
dental
vision
life and disability insurances
paid time off
paid holidays
401(k) plan with company match
Employee Assistance Program
accident insurance policies

Fulltime

Director of Health and Wellness

Responsible for providing overall leadership and management of the health and we...

Location

United States , Newburgh

Salary:

75000.00 - 82000.00 USD / Year

Dewolfe Place

Expiration Date

Until further notice

Requirements

Registered Nurse or Licensed Practical Nurse in good standing
Registered Nurse preferred
One (1) year in a nursing leadership role
Senior Living experience preferred
BSL Certification
Proficiency in computer skills, Microsoft Office and ability to learn new applications
Must demonstrate an interest in working with a senior population
Ability to communicate effectively speaking the primary language of the residents
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence

Job Responsibility

Ensures that community follows all federal, state, local laws and regulations as it pertains to clinical care
Responsible for collecting, analyzing, and reporting occurrence trends, and if necessary, develop/implement improvement plans
Partners with Administrator and other team members to analyze and maintain all resident and team member health safety
Partners with pharmacy consultant to provide optimal pharmaceutical services to residents
Responsible for clinical expertise of licensed nurses
Assists with educational presentations as assigned by administrator
Identifies ongoing needs and services of residents through the assessment/ Service Plan process including documentation for residents with a change in health care status
Responsible for overseeing the completion of the monthly updates and reporting any pertinent changes to the responsible party
Partners with other department coordinators to identify, review, and discuss potential change in service/medication levels if applicable
Ensures the resident’s service plan is updated as indicated by state regulations

What we offer

medical, dental, vision, life and disability insurances, paid time off, and paid holidays
401(k) plan with company match
Employee Assistance Program
accident insurance policies

Fulltime

Senior Manager, Clinical Supplies Management

iconplc

Location:
Poland , Warsaw

Category:
Logistics

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 05, 2026

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