Senior Clinical Project Manager / Senior Clinical Study Manager

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

We are exclusively supporting one of our longest standing clients in a significant expansion through the course of 2026.

As part of this, they are appointing a new position of Senior Quality Assurance Officer within their operational quality team on site in South London.

This person will strike the balance in hands on quality activities, as well as performing a deputy in absence of the Team Leader. As well as the usual operational quality activities such as batch release, deviation management and change control implementation, this person will need to take a lead on process ownership of investigation management and risk assessments.

If you enjoy working in a flat structured team, with broad responsibilities and a genuine opportunity for development, this could be the ideal career move.

This is a fully site based role in South London.

For further details, please contact Mark Bux-Ryan.

 

What you need to bring:

• Established QA experience within a GMP setting – ideally pharmaceuticals, although food manufacturing will be considered.
• Evidenced experienced of independent process ownership within QA activities – ideally investigation and risk assessment management
• Excellent stakeholder management skills
• Flexible and adaptable approach

We are seeking an experienced Head of Medical Writing to lead the strategy, development, and delivery of high-quality clinical and regulatory documents across all phases of drug development.

This role provides scientific and operational leadership for medical writing activities, supporting early- through late-stage programs and global regulatory submissions. The Head of Medical Writing will partner closely with Clinical Development, Regulatory Affairs, Biostatistics, and Safety to ensure accurate, timely, and compliant documentation.

 

Key Responsibilities

• Serve as the medical writing lead across one or more clinical programs
• Lead and/or author clinical documents including protocols, CSRs, and Investigator’s Brochures
• Support global regulatory submissions (INDs, NDA/BLA/MAA, health authority briefing documents, CTD Modules 2 and 5)
• Oversee timelines, coordinate cross-functional input, and ensure scientific accuracy and regulatory compliance
• Establish and maintain writing standards, templates, and best practices
• Facilitate efficient review cycles and ensure consistent scientific messaging across documents and programs
• Drive quality, process improvement, and scalable medical writing operations

 

Qualifications

• Advanced degree in life sciences (PhD, PharmD, MD, or MSc)
• 7–8+ years of medical writing experience in pharma, biotech, or CRO settings
• Strong experience across multiple phases of clinical development and global regulatory submissions
• Proven leadership in complex writing projects and cross-functional environments
• In-depth knowledge of ICH, GCP, and global regulatory requirements
• Experience in oncology, rare disease, or other complex therapeutic areas preferred

~20 Hours/Week

We are seeking a highly experienced biostatistical consultant to support a targeted therapy program in oncology, currently in pre-clinical to IND-enabling stages. This role will focus on studies where PK endpoints are critical to advancement, requiring strong expertise in adaptive study design and bioanalytical strategy.

This is a hands-on consulting opportunity suited for a biostatistician who thrives in early development environments and can operate independently while partnering cross-functionally.

 

Key Responsibilities

• Provide statistical leadership for studies designed to generate PK data in support of IND filings
• Lead and advise on adaptive study designs, including dose selection and optimization strategies
• Support and interpret bioanalytical (BA) and bioequivalence (BE) data to inform development decisions
• Contribute to study design, analysis planning, and data interpretation across non-clinical and early-phase development activities
• Collaborate closely with clinical pharmacology, bioanalytical, and development teams to ensure alignment on study objectives and deliverables
• Review and develop statistical input into protocols, analysis plans, and regulatory-facing documentation

 

Required Experience

• Significant experience in biostatistics within drug development, with a strong emphasis on adaptive design methodologies
• Deep expertise in PK-driven studies, particularly those supporting early development and IND-enabling work
• Proven experience with bioanalytical (BA) and bioequivalence (BE) data and study interpretation
• Background supporting oncology programs is preferred, though experience in PK-led development is prioritized
• Prior experience in biotech or pharmaceutical environments
• Ability to work autonomously in a part-time consulting capacity and navigate evolving program needs

 

Program Context

• Focused on targeted oncology therapies with limited public visibility
• Work will support progression toward IND filing rather than ongoing clinical trials
• High-impact role influencing early development strategy and decision-making

 

Engagement Details

• Part-time contract (~20 hours per week)
• Initial term of 12–18 months
• Flexible, remote working arrangement

Overview

We are seeking a Manufacturing Quality Engineer to support ongoing production operations in a fast-paced manufacturing environment. This role is responsible for maintaining product quality after release to production, including managing nonconformances, supporting investigations, and partnering with manufacturing and QC teams to resolve issues on the shop floor.

This is a hands-on, production-facing quality role focused on sustaining quality and ensuring consistency across manufacturing processes.

 

Key Responsibilities

• Investigate and resolve nonconformances (NCMRs), deviations, and production quality issues
• Support customer complaint investigations and drive timely resolution
• Maintain and update work instructions and quality documentation
• Partner with Quality Control (QC) to troubleshoot inspection and measurement issues
• Collaborate with manufacturing teams to ensure product is built and released in the correct condition
• Support root cause analysis and implement corrective actions where needed
• Contribute to continuous improvement of production quality processes

 

Required Qualifications

• Experience as a Quality Engineer in a manufacturing environment
• Hands-on experience supporting production floor activities
• Strong background in:
• Nonconformance management (NCMR)
• Mfg. Quality Investigations
• Root cause Analysis investigation
• Production Quality Support
• FMEA
• Customer / Complaint Quality Investigations 
• Ability to work cross-functionally with manufacturing, QC, and engineering teams

 

Preferred Qualifications

• Experience in regulated industries (medical device strongly preferred)
• Familiarity with GD&T and interpretation of complex engineering drawings
• Experience supporting CMM inspection activities (programming not required)
• Exposure or experience with Gage R&R (GR&R) (nice-to-have, not required)

 

What Makes a Strong Candidate

• Experience working in fast-paced or startup manufacturing environments
• Ability to balance regulatory compliance with practical problem-solving
• Strong communication skills and ability to work through cross-functional challenges
• Comfortable taking ownership of issues and driving them to resolution

 

Additional Notes

• This role is focused on production/sustaining quality, not initial validation or NPI work
• Candidates should be comfortable working onsite and directly on the manufacturing floor
• Opportunity to extend or convert based on performance and business needs