Senior Clinical Supplies Project Manager Job at iconplc (Reading)

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 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, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum: BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

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

Senior Project Manager

As a Senior Project Manager, Laboratory at ICON, you will design and analyse cli...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences or healthcare
Previous experience in project management within a laboratory or clinical research setting
Strong leadership skills with the ability to mentor and train junior PMs
Excellent communication and interpersonal skills, with the ability to represent the company at client meetings and internal meetings
Detail-oriented with strong organizational skills to effectively manage study documentation, timelines, and budgets
Willingness to travel as required (approximately 20%)
Minimum of 5 years of experience in a clinical laboratory, clinical trials, or customer management role in a life science related organization
Minimum of 3 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical supply packaging and distribution, medical imaging, data management

Job Responsibility

Ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories' (ICL) services, including the setup and day-to-day management of studies
Attend and represent ICL at Client meetings
Manage studies in accordance with Good Clinical Practice
Provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner
Represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON
Act as the sponsor’s main contact person in all matters regarding our central laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON Site Services Department
Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Central Laboratories (and ICON Clinical CRO if appropriate)
Enter protocol parameter information into PACS//ICOLIMS and other systems for new and/or amended protocols. Prepare and review clinical study specific materials. When possible, coordinate with other departments for the preparation of study specific materials
Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained and filed
Monitor study progress throughout the study, using ICON tools and communicate pertinent information to clients/sponsors. Provide Sponsors with study management reports. Provide client with support on ICO Labs system. Inform team leader about study progress. Escalate issues of potential client/site dissatisfaction to appropriate 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 Project Specialist

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

Location

Belgium , Rixensart

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Degree qualified, preferably in a science subject
Expertise in science background e.g. labs, to ensure proper project planning, prevent and mitigate risks and meet timelines is preferred
Clear understanding of project management and applicable tools
Good stakeholder management skills and a problem-solving mindset
Result-driven with a sense of urgency
Requires the ability to negotiate and manage competing priorities
Excellent interpersonal, verbal and written communication skills
Attention to detail and understanding how quality of own work impacts others and the business outcomes
Flexible attitude with respect to work assignments and an openness to new learning and role modelling adoption to change
Ability to manage multiple and varied tasks with enthusiasm and to teach others in these tasks

Job Responsibility

Project Management Plans initial set up and maintenance with Project Leader and Functional Lead input, communication of plans to the wider project team and support with execution of the plans
Maintenance of selected information in the integrated project management system and leading work with other functions on compliance of data in the project systems
Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight, including analysis of data
initiation and follow up on required actions in alignment with PL and FLs
Review of selected financial areas and follow up with stakeholders on required corrections. Provide reconciliations to PL, as agreed
Cooperation with Project Leader and Functional Leads on different action plans and follow up with the project team until action completion
Oversight of project team list, project system accesses and respective reviews
development of respective processes and roll out to the project team as needed
Study reporting and analysis with subsequent highlighting issues for project team
Maintaining systems and tools according to applicable SOPs

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
Tremendous long-term job security and prospects
Exciting professional challenges in inspiring studies, but with time for your outside life
Open and friendly work environment
Opportunities to develop long-term careers
Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments

Senior Manager, Clinical Supplies Management

An experienced clinical supply professional responsible for planning, coordinati...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

B.A./B.S., M.S., or Ph.D. in a technical concentration or other life sciences
A minimum of 8 years relevant experience
Expert in clinical supply planning/operations and vendor management
Excellent communication, collaboration, problem solving, and strategic thinking skills
Experienced in working within databases, systems, spreadsheets, and using presentation tools
Professional presence and keen insight regarding pharmaceutical development activities and inter-relationships between activities and systems
Process orientation
Resourceful and operationally oriented with ability to lead staff
Ability to develop and critically analyze technical documentation
Experience in the application and interpretation of cGMP, GCP requirements to pharmaceutical development processes and issues that arise

Job Responsibility

Provides clinical supply and product expertise to project teams and develops compound/drug related planning documentation and R&D protocol reviews
Proactively initiates discussion of plans with clinical and technical teams
Independently develops packaging and labeling documentation and Astellas system documentation with first-pass approval quality
Monitors international inventory and shipping trends for efficiency
Monitors packaging activities and department processes and outlines and proposes innovations for continual improvement
Supports staff development through demonstration and training
Serves as a consultative resource in the review of staff documentation and provides guidance
Establishes and monitors project budgetary spend
Remains current with industry practice, new processes, global Astellas business practice, and emerging Regulatory requirements and is responsible for raising awareness and educating the group on an ongoing basis

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

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

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Senior Clinical Supplies Project Manager

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