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

Site Manager - Healthcare Sector

The Site Manager will oversee all aspects of site preparation and readiness, inc...

Location

United Arab Emirates , Abu Dhabi

Salary:

25000.00 - 30000.00 AED / Month

Toshiba EMEA

Expiration Date

January 31, 2026

Requirements

Bachelor’s degree in Civil Engineering or a related field
A minimum of 10+ years of relevant experience in Site Management, preferably in radiotherapy, medical field, and or civil engineering
Understanding CAD drawings in essential
MEP works
Execute the project as per plan, Maintain HSEQ requirements and assist in project cash flow
The ability to explain basic design ideas and plans clearly to the Clients, Project consultants, Engineers Office, Vendors, and Subordinates
Having overall responsibility on project results including risks, opportunities and claims
Strong presentation and communication skills with the ability to present basic, technical information to a wide audience
High competence in technical writing, systems development and utilization

Job Responsibility

Ensure the customer’s physical site (hospital or clinic) meets all the infrastructure requirements: civil works, electrical supply, HVAC, radiation shielding, safety, ventilation, clean room, etc.
Coordinate site inspections & feasibility surveys
perform on‐site inspections to validate that construction / facilities are prepared according to Toshiba’s Site Preparation Guide
Work with hospital staff, architects, engineers, contractors, rigging and construction companies, local suppliers to ensure that all pieces (building, utilities, room design) match specifications
Liaise with local regulatory authorities (for safety, radiation protection, health codes) as needed
Develop and maintain project schedules along with the Project Manager for the site readiness phase: Civil Works, Installation, logistics, commissioning
Coordinate timelines with internal departments: sales, logistics, installation, service, quality, etc., to align delivery & handover
Be the main point of contact for the customer for all site-related matters: clarifying requirements, communicating delays/issues, managing expectations
Ensure a smooth handover from construction to installation teams
ensure the high level of customer satisfaction through the installation & commissioning phases

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

New

Executive Director, Global Clinical Operations

We are seeking an Executive Director, Global Clinical Operations, (GCO), who wil...

Location

United States

Salary:

285000.00 - 320000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion
Minimum of 7 years line management experience
Minimum of 3 years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc.
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly
Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Manage and plan CTO resourcing for assigned programs
Lead, build and mentor CTO team supporting assigned program(s)
Serve as a member on Clinical Operations Leadership Team (COLT)
Create and support implementation of Clinical Operations processes, platforms and/or systems
Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs
Clinical operations representative on Program Teams (PT)
Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans
Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
Strong collaboration and partnership with cross functional colleagues globally

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

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including 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

Manufacturing Manager - Site Lead - ACDM

Site lead for Contract Manufacturing Organizations (CMOs). Single point of accou...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s in Business Administration, Engineering, or Science-related field
5+ years of experience in DP, or packaging manufacturing environment
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
1+ years of project management experience leading multi-functional and multi-location team
1+ years of experience across ACDM
Ability to travel +/- 20% of time (domestic and international)
Demonstrated competencies of lower GCF levels
Demonstrated matrix management and influencing skills
Manufacturing and cGMP knowledge / experience

Job Responsibility

Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management
assess industry trends, internal network, and technology advancements as tools to improve contract site performance
Manage budget development, monitoring, and reporting
create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
monitor and improve financials with CMO
actively manage and communicate forecasts to the sites and manage capacity planning
Drive operational excellence and champion change
Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings
drive improvements at contract sites
sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management

Contract Development and Manufacturing Senior Manager

Oversee Amgen Contract Development and Manufacturing (ACDM) sites through execut...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Manufacturing or Operations experience
Master’s degree and 6 years of Manufacturing or Operations experience
Bachelor’s degree and 8 years of Manufacturing or Operations experience
Associate’s degree and 10 years of Manufacturing or Operations experience
High school diploma / GED and 12 years of Manufacturing or Operations experience
Candidates must demonstrate professional fluency in English, including strong written and verbal communication skills
8+ years proven experience in Pharmaceutical Manufacturing
8+ years working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
5+ years demonstrated ability working with external parties and/or leading cross-functional teams for clinical and/or commercial products
3+ years of project management experience leading multi-functional and multi-location team

Job Responsibility

Project leadership for Amgen modalities (Synthetic DP/FDP, Biologics DP/FDP) external projects spanning development, clinical and commercial manufacture
Develop scopes of work in close partnership with functional leads
Build and maintain positive relationships with Process Development and other functions
Manage of multiple assignments and/or business processes
Establish and maintain external collaborations and monitor supplier performance
Manage purchase orders, financial forecasting, and associated budget for externalization
Ensure projects and/or programs meet results, compliance, speed, quality, and cost
Identifying project optimization opportunities
Contribute to ACDM knowledge development including assessment of industry trends, technology advancement, and contract manufacturing landscape
Ability to understand legal contracts to support negotiation process with suppliers

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Clinical Supplies Project Manager

iconplc

Location:
United Kingdom , Reading

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 16, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Senior Clinical Supplies Project Manager