Programme/Project Manager

As part of a significant operational expansion we are delighted to be exclusively partnering with a market leading global brand and supporting the hire of a new Laboratory Validation Officer.

This person will focus predominantly on method validation activities from bench to HPLC. There may be the need for some degree of method development.

Working in a small team this role must have independent and “can do” focus.

The opportunities in the business for development and progression are strong and they welcome a proactive and ambitious attitude.

For further details please contact Mark Bux-Ryan

 

Key experience

• Previous experience in method validation of HPLC
• Pharmaceutical (or healthcare/nutraceutical) GMP experience
• Any method development experience is advantageous
• Problem solving mindset with ability to work independently
  

As part of a significant operational expansion and investment into the Quality team, we are delighted to be exclusively partnering with a market leading global brand and supporting the hire of a new QA Officer, with a systems focus.

The successful hire will work within the QMS team and will focus their time around managing and conducting internal audits, as well as writing change controls, amongst other activities. Given the size of the team and the expansion of operations, the need for working quickly and confidently across all levels is critical.

The opportunities in the business for development and progression are strong and they welcome a proactive and ambitious attitude.

For further details please contact Mark Bux-Ryan.

 

Key experience

• Previous experience in managing quality systems / QMS
• Knowledge of QPULSE is an advantage
• Pharmaceutical (or healthcare/nutraceutical) or food manufacturing GMP experience essential
• Must have experience in managing and writing change controls
• Internal auditing experience essential

SharePoint Consultant (Junior–Mid) - Contract - 6 Months - Fully Remote - Umbrella Inside IR35 - No Sponsorship

 

About the Role

We’re looking for a SharePoint Consultant with a strong business analysis mindset to support the delivery of SharePoint and Microsoft 365 solutions across multiple business units.

This role sits at the intersection of business and technology ideal for someone who enjoys working with stakeholders, gathering requirements, and translating them into clear, structured deliverables for technical teams.

If you have 2–3 years of SharePoint experience and are looking to grow into a more consultative role, this is a great opportunity to build your career.

 

What You’ll Be Doing

• Work with business stakeholders to gather, analyse, and document SharePoint requirements
• Translate business needs into functional and technical specifications
• Partner with project and technical teams to support solution delivery
• Produce detailed project documentation and requirement reports (Excel-based templates)
• Participate in stakeholder meetings, workshops, and discovery sessions
• Ensure requirements are clearly defined, structured, and aligned to business outcomes
• Support ongoing SharePoint initiatives and improvements

 

What We’re Looking For

• 2–3 years of experience with SharePoint (Online preferred)
• Strong business analysis or requirements gathering skills
• Ability to translate business needs into technical requirements
• Experience creating structured documentation (especially Excel-based reporting/templates)
• Familiarity with:
• SharePoint lists, libraries, and document management
• Permissions and basic workflows
• Strong communication skills and confidence working with non-technical stakeholders
• Highly organized with excellent attention to detail

 

Nice to Have

• Exposure to Power Platform (Power Automate / Power Apps)
• Experience working on projects (Agile or Waterfall)
• Understanding of SharePoint governance or information architecture

Oncology Clinical Development | Early Phase Biotech

A rapidly growing clinical-stage biotechnology organization is seeking two experienced Senior Clinical Project Managers / Senior Clinical Study Managers to support the execution of global oncology clinical trials across early and late-stage development.

These individuals will play a critical role in leading complex international studies, including First-in-Human (FIH) programs involving novel biologic therapies. This is an opportunity to join a highly collaborative and scientifically driven clinical operations team focused on advancing innovative oncology treatments in a fast-paced development environment.

 

Key Responsibilities

Global Clinical Trial Leadership

• Lead the end-to-end operational execution of global Phase I–III oncology studies from startup through closeout
• Oversee timelines, budgets, quality, and cross-functional deliverables to ensure successful study execution
• Support protocol development, country/site activation strategies, enrollment planning, and study reporting activities
• Drive operational excellence across complex oncology programs, including FIH and registration-enabling studies

Study Oversight & Vendor Management

• Manage CROs and external vendors across monitoring, data management, imaging, laboratories, ePRO, and related services
• Proactively identify operational risks and implement mitigation strategies
• Ensure inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements
• Oversee forecasting, accruals, budget tracking, and change order management

Cross-Functional Collaboration

• Lead global study team meetings and facilitate effective decision-making across stakeholders
• Partner closely with Clinical Development, Medical, Regulatory, Biometrics, Safety, and external collaborators
• Build and maintain strong relationships with investigators, academic institutions, and key external partners

 

Qualifications

Required Experience

• 10+ years of clinical operations experience within biotech, pharma, or CRO environments
• 5+ years leading global oncology clinical trials
• Strong experience supporting early phase oncology studies, including FIH, dose escalation, and expansion cohorts
• Demonstrated success managing global CROs and multi-vendor clinical programs
• Deep understanding of oncology drug development and complex clinical trial operations
• Strong knowledge of ICH-GCP and global regulatory standards
• Excellent leadership, communication, and stakeholder management skills
• Ability to operate independently in a fast-paced and evolving environment

Preferred Background

• Experience with immuno-oncology, targeted therapies, or solid tumor indications
• Exposure to registration-directed or late-stage studies
• Prior experience within small or emerging biotech companies
• Advanced scientific degree and/or project management certification preferred

 

Why This Opportunity?

• High visibility role within a growing oncology organization
• Opportunity to lead innovative global oncology studies from early development onward
• Collaborative, science-driven culture with strong executive exposure
• Meaningful impact on cutting-edge therapies for patients with unmet medical needs

Cardiovascular Medical Device | Clinical-Stage Innovation

An innovative and rapidly growing clinical-stage medical device organization is seeking experienced Clinical Research Associates to support a pivotal cardiovascular clinical program. This is an exciting opportunity to join a highly collaborative clinical operations team developing next-generation technologies in a fast-growing therapeutic area.

The organization is advancing a novel structural heart platform through ongoing clinical development and expanded global trial activities. These hires will play a critical role in supporting investigative sites, driving study execution, and ensuring operational excellence across clinical trial activities.

Candidates may be considered at either the CRA II or Senior CRA level depending on experience and qualifications.

 

Key Responsibilities

Site Management & Monitoring

• Serve as the primary point of contact for assigned investigational sites
• Conduct qualification, initiation, interim monitoring, and close-out visits
• Provide site training for investigators, coordinators, and research staff
• Ensure compliance with study protocols, GCP, SOPs, and applicable regulatory requirements
• Support site performance, enrollment progress, and subject retention efforts

Clinical Operations Support

• Support study startup activities, including IRB/EC submissions and essential document management
• Maintain inspection readiness of study documentation and eTMF systems
• Contribute to the development of study-related materials, including manuals, worksheets, and training tools
• Assist with investigational product management and clinical vendor coordination
• Participate in data review activities, query resolution, and EDC support

Cross-Functional Collaboration

• Partner closely with internal clinical operations, data management, regulatory, and quality teams
• Participate in project meetings and provide regular site and study status updates
• Identify operational risks and proactively escalate issues when appropriate
• Support audit readiness activities and clinical inspection preparation

 

Qualifications

Required Experience

• Minimum 5+ years of direct clinical monitoring and site management experience
• Experience managing clinical trial sites from startup through closeout
• Strong understanding of ICH-GCP, FDA, and ISO regulations
• Excellent organizational, communication, and problem-solving skills
• Ability to manage multiple priorities in a dynamic environment
• Experience working independently and collaboratively across cross-functional teams
• Proficiency with EDC systems, Microsoft Office Suite, and clinical documentation platforms

Preferred Background

• Experience within medical device and/or cardiovascular clinical trials
• Experience working within small or emerging biotech/medtech organizations
• Exposure to pivotal or post-market clinical studies
• Prior experience supporting trials without heavy CRO oversight preferred

 

Additional Information

• Remote opportunity with preference for candidates located in the New England region
• Travel requirements may vary and could reach approximately 50% during peak study activity
• Opportunity to join a growing organization at an exciting stage of clinical development

 

This position offers the chance to make a meaningful impact within a highly innovative clinical program while working alongside an experienced and collaborative team dedicated to advancing patient care through cutting-edge medical technology.

A leading, global pharmaceutical manufacturing business is seeking an experienced Validation Engineer to support delivery of a major site validation and capital programme on a 12-month contract.

This is a high-impact role within a busy engineering environment, offering exposure across equipment, utilities, facilities, and laboratory systems, with a need for hands-on execution specialists. If this capability brings with it project lead experience, this will also be valued.

 

The Role

Working as part of the Engineering function, you will support delivery of a structured site-wide validation programme, alongside capital project activity.

Responsibilities will include:

• Supporting delivery of the Site Validation Master Plan (SVMP)
• Generating and reviewing validation / qualification documentation (IQ/OQ/PQ, FAT/SAT, etc.)
• Leading or supporting execution of validation activities across manufacturing, lab, and utility systems
• Working closely with internal stakeholders to ensure GMP and regulatory compliance
• Reviewing vendor documentation and supporting supplier-led validation activities
• Participating in FATs and site-based commissioning activities where required
• Managing or supporting third-party contractors and vendors
• Owning change controls, deviations, and CAPAs linked to validation activities
• Supporting requalification, new equipment introduction, and decommissioning activities

 

Project / Programme Exposure

In addition to core validation delivery, there is scope to contribute at a more strategic level:

• Supporting or leading capital project delivery (GxP and non-GxP)
• Defining project scope, timelines, and deliverables
• Managing project risks, budgets, and progress reporting
• Coordinating cross-functional stakeholders and teams
• Driving project governance, change management, and close-out activities

 

What We’re Looking For

We’re open to a range of profiles, from strong delivery-focused CQV engineers to more senior, project-led professionals:

• Experience in validation / CQV within GMP-regulated environments (pharma / biotech / related)
• Strong understanding of validation principles across equipment, utilities, or facilities
• Experience authoring and executing validation documentation
• Ability to work effectively across cross-functional teams and stakeholders
• Confidence operating in a fast-paced, project-driven environment
• Strong communication and problem-solving skills