Clinical study manager Work, Jobs in West Berkshire, Brk (with Salaries)

Clinical Study Manager (Medical Devices)
Amber Therapeutics —Didcot
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Leadership
Quick apply
6d
Clinical Operations Manager
University of Oxford —Oxford
- £49,119 - £58,265 a year
- Full-time
- Organisational skills
- Communication skills
Trial Committee Manager
PSI CRO —Oxford
- Full-time
- Remote
- English
- Bachelor's degree
- Communication skills
Quick apply
9h
Sr. Clinical Project Manager (Europe)
Allucent —Bracknell
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- English
- Flexible schedule
- Referral programme
Quick apply
Senior Study Startup Specialist
PSI CRO —Oxford
- Full-time
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
Quick apply
Project Manager, eCOA
IQVIA —Reading
- Full-time
- Remote
- Microsoft Powerpoint
- Travel
- Communication skills
- Work from home
13d
Clinical Research Fellow
University of Oxford —Oxford
- £38,831 - £73,992 a year
- Full-time
Senior Product Manager, Women's Health - Europe
BD —Winnersh
- £59,100 - £90,150 a year
- Marketing
- English
- Master's degree
Senior Clinical Trial Case Manager
CSL Behring —Maidenhead
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
3d
Therapy Specialist
Baxter —Newbury
- Microsoft Powerpoint
- Microsoft Word
- Sales
- Annual leave
Research Scientist – Autoimmune Research
Immunocore —Oxford
- Doctoral degree
- AI
- Communication skills
Clinical Research Associate I
Fortrea —Maidenhead
- Full-time
Medical Education Manager
Frimley Health NHS Foundation Trust —Frimley
- £51,657 - £58,785 a year
- Full-time
- Management
- Budgeting
- Leadership
3d
Connected Devices - Primary analyst, Spirometry
IQVIA —Reading
- Full-time
- Remote
- Computer literacy
- Mentoring
- Computer skills
- Work from home
Senior Clinical Data Manager - sponsor dedicated - oncology
Fortrea —Maidenhead
- Full-time
- Remote
- Presentation skills
- Mentoring
- Leadership
Local Study Associate Director
IQVIA —Reading
- Full-time
- Remote
- English
- Bachelor's degree
- No degree
- Work from home
Data Team Lead
IQVIA —Reading
- Full-time
- Remote
- Bachelor's degree
- Mentoring
- Leadership
- Work from home
12d
Senior Quality Assurance Manager (Clinical)
Bio Pharma Resourcing —Thames Valley
- £35,000 - £40,000 a year
- Computer literacy
- Travel
- Computer skills
Senior Clinical Technology Specialist
IQVIA —Reading
- Full-time
- Remote
- Analysis skills
- Bachelor's degree
- SharePoint
- Work from home
Medical Strategy Lead, Oncology-Clinical Development (Centre of Excellence)
IQVIA —Reading
- Full-time
- Remote
- English
- Databases
- Mentoring
- Work from home

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clinical study manager jobs near west berkshire, brk

Clinical Study Manager (Medical Devices)

Amber Therapeutics
Didcot

Quick apply

Job details

Full-time
6 days ago

Benefits

Company pension

Qualifications

Healthcare research operations
Clinical research
Stakeholder collaboration
Stakeholder liaison
Bachelor's degree
Multidisciplinary collaboration
Good Clinical Practice (GCP)
Leadership
Communication skills
Good Clinical Practice (ICH-GCP) guidelines

Full job description

Are you an experienced Clinical Study Manager with EU medical device trial expertise? Want to play a pivotal role in bringing innovative medical devices to market? Apply now to make a difference!

Amber Therapeutics are looking for a Clinical Study Manager to make a real impact on patients’ lives as we develop a closed-loop neuromodulation therapy to treat mixed urinary incontinence. This is a full-time, hybrid role (c. one day a week onsite in Harwell, Oxfordshire) with regular travel to the Europe and occasional travel to the US.

The Role

As Clinical Study Manager, you will take ownership of the operational delivery of international clinical studies, ensuring they are executed on time, within budget and in compliance with study protocols, Good Clinical Practice, ISO 14155 and internal quality standards. Working in a fast-paced, collaborative environment, you will lead cross-functional teams, manage external vendors and clinical sites, and act as the primary operational contact for stakeholders throughout the study lifecycle. You will drive site performance, patient recruitment, data quality and proactive risk management, ensuring issues are identified and resolved quickly to keep studies on track. This is an exciting opportunity to play a key role in bringing innovative medical technologies to patients, with regular travel across Europe to support clinical trial sites and our Belgium office, and occasional travel to the US to support clinical sites and patient visits.

Key Responsibilities:

Lead study start-up activities, including site selection, qualification and activation.
Manage CROs, vendors and third-party suppliers to ensure high-quality, timely delivery.
Monitor site performance, patient recruitment and operational progress, implementing solutions to overcome challenges.
Ensure compliance with study protocols, Good Clinical Practice (GCP), ISO 14155, regulatory requirements and company SOPs.
Coordinate study communications and provide regular progress updates to senior leadership.
Oversee data cleaning, analysis, study results generation, device supply and trial logistics.
Collaborate cross-functionally to support product improvements, technical investigations and issue resolution.
Build and maintain strong relationships with investigators, key opinion leaders and clinical sites.
Become a subject matter expert in study protocols and the use of investigational devices.
Provide operational support for clinical sites, including site and patient visits where required.
Support audit readiness, inspections, data integrity and timely resolution of data queries.
Provide guidance to internal teams and site staff, supporting protocol and device training where appropriate.
Travel regularly throughout Europe, with occasional travel to the US, to support clinical trial activities.

Skills & Experience

Essential

Bachelor’s degree in a scientific or health-related field or equivalent.
Extensive experience in clinical trial management in medical devices.
Experience of set-up, management and closeout of EU CE mark trials.
Strong knowledge of GCP and ISO14155.
Proven experience in vendor oversight and cross-functional leadership.
Excellent written and oral communication skills.
Effective team-player, agile and thrives in versatile environment.

Desirable

Experience with active implantable devices and/or neuromodulation therapy.
Experience in UI therapeutic area.
Site management / field support experience.
Premarket trial experience.
An additional European language

About Us

Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber’s fully implantable PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. The therapy is configurable to the individual’s need and able to respond dynamically to different events, adapting as needed between modes of operation. This principle can be used in broader functional disorders of the nervous system that the Company’s academic partnerships are exploring.

What We Offer

This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme, equity scheme and 27 days holiday (plus bank holidays).

Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.

Quick apply

Refine Your Search

clinical study manager jobs in west berkshire, brk

Clinical Study Manager (Medical Devices)

Clinical Operations Manager

Trial Committee Manager

Sr. Clinical Project Manager (Europe)

Senior Study Startup Specialist

Project Manager, eCOA

Clinical Research Fellow

Senior Product Manager, Women's Health - Europe

Senior Clinical Trial Case Manager

Therapy Specialist

Research Scientist – Autoimmune Research

Clinical Research Associate I

Medical Education Manager

Connected Devices - Primary analyst, Spirometry

Senior Clinical Data Manager - sponsor dedicated - oncology

Local Study Associate Director

Data Team Lead

Senior Quality Assurance Manager (Clinical)

Senior Clinical Technology Specialist

Medical Strategy Lead, Oncology-Clinical Development (Centre of Excellence)

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