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

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 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

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

Senior Clinical Affairs Specimen Operations Manager

The Sr. Clinical Affairs Specimen Operations Manager leads planning and executio...

Location

United States , Madison

Salary:

91000.00 - 155000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in health or life sciences, supply chain, engineering, or a related field relevant to specimen logistics or clinical operations
7+ years of experience in clinical trial operations, specimen or sample management, logistics, supply chain, or related operational support of clinical studies
Demonstrated experience coordinating cross‑functional activities, applying working knowledge of project management principles to support execution across multiple studies or initiatives

Job Responsibility

Leads operational planning and strategic management of specimen logistics for assigned clinical studies, ensuring supply, collection, shipment, receipt, processing, storage, and reconciliation meet protocol and regulatory standards
Translates study requirements into actionable specimen operations plans, coordinating timelines, deliverables, and execution with clinical, laboratory, program, and external partners
Manage and analyze key specimens and supply performance metrics (e.g., kit usage, sample quality, chain of custody, turnaround times) to identify risks, opportunities, and data‑driven improvements supporting reliable study delivery
Problem-solves and resolves specimen and logistics issues, applying sound judgment to prioritize actions, escalate when needed, and ensure timely resolution in line with established procedures
Lead continuous process improvement, contributing to workflow documentation, standard practices, and initiatives that enhance efficiency, consistency, and scalability across studies
Provides guidance, coaching, and knowledge sharing to less‑experienced team members, serving as a resource on specimen operations processes, tools, and best practices within clinical research
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance
Ability to act with an inclusion mindset and model these behaviors for the organization

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
Retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

Clinical Operations Senior Project Manager

The Clinical Operations Project Manager ensures the oversight of the activities ...

Location

United States , San Mateo

Salary:

147817.00 - 175014.00 USD / Year

Dompé

Expiration Date

Until further notice

Requirements

Bachelor’s/Master’s Degree in Pharmacology, Biotechnology or related scientific discipline
7-12 years of experience in similar roles, preferably in the Pharmaceutical/Life-science sector
Project Management Certification is preferred
Languages: Italian English (fluent)
Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office)
Knowledge of GCP/ICH phase I-IV clinical trials and observational studies
Knowledge of research and clinical trial methodologies
Knowledge of CRO industry
Knowledge of Project Management
Knowledge of Pharmaceutical sector

Job Responsibility

Supervises the CRO activities in all the study conduct phases (start-up, maintenance, study closure)
Is responsible to coordinate and drive in a functional matrix model the multidisciplinary team assigned to each of the company clinical trials
Is involved in the CRO process selection in compliance with current company SOPs
Is responsible for set-up and progress of the study according to the company current standards/regulation and ensures that committed targets are met until study completion
Collaborates with the local Medical Department and Site Engagement Manager to identify potential investigators to be included in the clinical network of Dompé
Collects and manages input to the study protocol and operational aspects of the study, participates in the planning of Investigator Meetings
Works with Local Drug Supply Management and ensures IMP is available to commence and complete assigned trial/assigned trial sites
Maintains knowledge of the study protocol to answer standard operational questions from CRAs of the CROs, sites, and internal Country/Cluster personnel
Ensures the performance of the CRO assigned to the study in order to be on time, budget and quality by collecting, analyzing and reporting detailed performance KPI dashboards
Closely collaborates in autonomy with the CRO project management team in order to ensure that anticipated study milestones and target are met and in order to put in place corrective or mitigation plans to address risks that may impact missing study objectives

What we offer

Comprehensive medical benefits
Generous vacation / holiday time off
Competitive 401(K) matching

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

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