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Quality Assurance Manager

18 - 22 Queen Anne Street, London, W1G 8HU
Full Time
Competitive Salary

Queen Anne Street Medical Centre (QASMC) is an acute private hospital that provides day surgery, diagnostic testing, chemotherapy, clinical trials, and laboratory and pharmacy services. Classed as an acute hospital, it delivers varied disciplines.

We employ people across a wide variety of disciplines in both clinical and non-clinical roles. Applications are invited for a Quality Assurance Manager to join the Quality Assurance department at the Queen Anne Street Medical Centre.

The applicant must have a minimum of 3 years previous work experience in Quality Assurance management systems, auditing and have a detailed knowledge of UK clinical trial regulations and GCP guidelines. Applicants should be currently working at management level. A qualification in Quality Management Systems is desirable.

Previous experience working in a CRO organisation and facilitating MHRA inspections is highly desirable. You will have proven report, SOP and Policy writing skills. Recent experience in clinical trials and/or the drug development field is essential. You will have excellent leadership, communication and interpersonal skills. The ability to be flexible and work within a dynamic fast paced environment is essential.

The QA Manager will be required to perform internal and external audits ensuring that corrective and preventative outcomes are realised. In this role, you will be expected to develop and maintain effective QA systems and contribute to process development. The QA Manager will also be expected to provide leadership in hosting GCP inspections and with other regulatory inspections and audits.

Benefits
•25 Days Holiday per Annum, plus UK Public Holidays
•Day Off for Your Birthday
•A Contributory Pension Scheme
•Private Healthcare Scheme

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Resident Medical Officer

18 - 22 Queen Anne Street, London, W1G 8HU
Full Time
Competitive Salary

QASMC is an acute private independent hospital located in Central London. The hospital comprises of a theatre, clinical research unit (Heart Lung Centre), cardio-pulmonary diagnostics centre and consulting suites.

We require a Resident Medical Officer to provide medical care and clinical support to all departments within QASMC and to assist with the safe conduct of clinical trials ensuring that ICH-GCP guidelines are adhered to at all times.

Clinical Duties:

To assist with the development of existing and new clinical services at QASMC

To be available to give clinical advice and reassurance when requested by nursing and other health professionals.

To undertake or perform any specialist duties as requested by the Consultants concerned.

To maintain accurate medical records.

To prescribe medication and to monitor drug requirements throughout the facility as appropriate.

To provide leadership and co-ordination of medical emergencies that may occur within the hospital.

To participate in the resuscitation team bleep holding responsibilities and ensure effective and timely response to medical incidents.

To provide clinical support to ensure the safe conduct of Exercise ECG and Cardio Pulmonary Exercise Testing

Clinical Research:

To contribute to the management of clinical research studies and act as sub-investigator as required

To provide medical input to the running of clinical studies within the Centre.

To carry out research in line with UK Clinical Trial Regulations, GCP, current national and international guidelines on clinical trials.

To develop and maintain a solid working knowledge of the current asthma and COPD management guidelines.

To conduct and support safe research techniques, including bronchial challenge testing, nasal allergen testing and nasal sampling techniques.

To be fully cognisant of medical requirements for all study protocols.

Qualifications and Skills
•At least 2 years clinical experience, post full registration with recent experience of managing acute emergencies and general medicine.
•Hold full GMC and MRCP accreditation
•Exhibit high standards of clinical assessment skills
•Hold a valid ALS

Benefits
•25 Days Holiday per Annum, plus UK Public Holidays
•Day Off for Your Birthday
•A Contributory Pension Scheme
•Private Healthcare Scheme

Apply

Director of Clinical Research

18 - 22 Queen Anne Street, London, W1G 8HU
Full Time
Competitive Salary

Respiratory Clinical Trials (RCT) is a specialist research unit located within a private independent hospital, Queen Anne Street Medical Centre, in Central London. The unit includes a specialised biomarker laboratory. It is dedicated to evaluate the mechanisms of airways disease and the properties and clinical potential of new therapeutic agents in allergy, asthma and COPD. We specialise in clinical trials and drug development with an emphasis on establishing new methodologies and biomarkers.

We require a Director of Clinical Research to join the research team. For the right candidate, this presents an excellent opportunity to work in a multidisciplinary research department within a dynamic clinical setting.

This role involves scientific research and development and operational oversight of all clinical trial activity.

Key responsibilities:

Clinical Oversight
•To lead the setting and implementation of standards of good clinical practice within the organisation.
•Perform procedures according to GCP/GCLP and to study protocol.
•To develop/ maintain excellence in clinical trial practice.

Project Management
•To manage all of the clinical trial processes and activities effectively, efficiently and collaboratively.
•To oversee clinical trial setup within the clinical, pharmacy and laboratory departments.
•To be fully cognisant of resource requirements for all study protocols.

Performance Management
•Manage the staff resource and financial budgets within agreed parameters, to achieve strategic objectives and tactical plans.
•Clinical Trial Unit and Laboratory key facility utilisation and logistics planning to gain maximum benefit from usage and allocated space within the department.

Business Development
•To initiate, establish and develop new services within the departments when required, in line with strategic aims of the organisation.
•To play an active role at a strategic level in the development of RCT and affiliated companies.

Managing Risk
•To be responsible for the ongoing management of a high standard of risk management and reporting on time and in line with best practice.

Senior Management Team & Communication
•To play an active role in the senior management team of the hospital, and to act as a resource when required to develop best practice.
•To communicate at various levels to enhance the reputation of the study management organisation and the hospital.

The ideal candidate will have:
•Either PhD or suitable degree in a relevant scientific field
•At least 2 years’ experience of working at a managerial level
•Experience of working to GCP/GCLP standards
•Experience in a clinical trial setting, in particular asthma & COPD and
•At least 2 years’ experience of clinical trial project management
•Advanced computer literacy for presentation of data, using Office Software

Apply