Clinical study manager Work, Jobs in Didcot, Oxf (with Salaries)

Clinical Study Manager (Medical Devices)
Amber Therapeutics —Didcot
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Leadership
Quick apply
8d
Clinical Operations Manager
University of Oxford —Oxford
- £49,119 - £58,265 a year
- Full-time
- Organisational skills
- Communication skills
Clinical Project Manager I
Perspectum —Oxford
- £33,000 - £45,000 a year
- Full-time
- Communication skills
Quick apply
1d
Clinical Project Manager II / Sr Clinical PM
Perspectum —Oxford
- Full-time
- Business development
- Continuous improvement
- Mentoring
Quick apply
1d
Trial Committee Manager
PSI CRO —Oxford
- Full-time
- Remote
- English
- Bachelor's degree
- Communication skills
Quick apply
2d
Senior Study Startup Specialist
PSI CRO —Oxford
- Full-time
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
Quick apply
Sr. Clinical Project Manager (Europe)
Allucent —Bracknell
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- English
- Flexible schedule
- Referral programme
Quick apply
Study Start Up Manager
Fortrea —Maidenhead
- Full-time
- Remote
- English
- Bachelor's degree
1d
Senior Clinical Trial Case Manager
CSL Behring —Maidenhead
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
6d
Senior Manager, Clinical Operations - FSP Resource & Vendor Management
CSL Behring —Maidenhead
- £170,000 - £201,000 a year
- Full-time
- Master's degree
- Bachelor's degree
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
Senior Quality Assurance Manager (Clinical)
Bio Pharma Resourcing —Thames Valley
- £35,000 - £40,000 a year
- Computer literacy
- Travel
- Computer skills
Project Manager II
Elsevier —Oxford
- Full-time
- Data analysis skills
- Analysis skills
- Agile
- Flexible schedule
8d
Clinical Research Associate I
Fortrea —Maidenhead
- Full-time
Data Team Lead
IQVIA —Reading
- Full-time
- Remote
- Bachelor's degree
- Mentoring
- Leadership
- Work from home
14d
Research Scientist – Autoimmune Research
Immunocore —Oxford
- Doctoral degree
- AI
- Communication skills
Therapy Specialist
Baxter —Newbury
- Microsoft Powerpoint
- Microsoft Word
- Sales
- Annual leave
Manager II, Clinical Operations FSO and FSP (UK/IRE)
Fortrea —Maidenhead
- Full-time
- Nursing
- Continuous improvement
- Leadership
9d
NIHR SPCR Nursing Commercial Research Fellow
University of Oxford —Oxford
- £49,119 - £74,896 a year
- Part-time
- Research
- University
- Leadership

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Clinical Study Manager (Medical Devices)

Amber Therapeutics
Didcot

Quick apply

Job details

Full-time
8 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 didcot, oxf

Clinical Study Manager (Medical Devices)

Clinical Operations Manager

Clinical Project Manager I

Clinical Project Manager II / Sr Clinical PM

Trial Committee Manager

Senior Study Startup Specialist

Sr. Clinical Project Manager (Europe)

Study Start Up Manager

Senior Clinical Trial Case Manager

Senior Manager, Clinical Operations - FSP Resource & Vendor Management

Senior Clinical Data Manager - sponsor dedicated - oncology

Local Study Associate Director

Senior Quality Assurance Manager (Clinical)

Project Manager II

Clinical Research Associate I

Data Team Lead

Research Scientist – Autoimmune Research

Therapy Specialist

Manager II, Clinical Operations FSO and FSP (UK/IRE)

NIHR SPCR Nursing Commercial Research Fellow

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