ROLE: Clinical Compliance Manager (Associate) - Biotech
LOCATION: Surrey, Berkshire, Middlesex, London

Fantastic new opening for an Associate Clinical Compliance Manager (GCP, QA) to join this innovative, growing Biotech from their European HQ in Surrey. The position will give you full oversight and ownership on all compliance and QA activities within Europe, documentation review, internal process audits and SOPs in place.

Perfect opening for those with strong regulatory compliance and GCP quality experience looking to work in a close knit, growing Biotech.

COMPANY BACKGROUND:

A small, developing US based biotech with international scope that have been established for over 20yrs and continue to grow. Focused in the medical development of cardiovascular, oncology and infectious diseases they are confident in their strong pipeline in these fields and continue to grow in 2012. Offering a lot of autonomy and project ownership this requires someone who has a pro-active approach to work and can represent the company effectively.

ROLE RESPONSIBILITIES:

Working from their EU headquarters west of London in Surrey, England the position as Associate Manager – GCP Compliance will see you working across their European sites:

·         Manage and implementation of ensuring full GCP compliance across all clinical studies

·         Annual audit scheduling, preparing necessary budget and conduct

·         Interaction with regulatory authorities and audit inspections

·         Quality review of protocols, case report forms and study documents

This role is critical to the continued success and growth of this privately owned Biotech, offering a dynamic, motivated internal R&D team and external vendors.

SKILLS DESIRED:

·         Strong pharmaceutical industry background – 10+yrs

·         Proven experience of Quality Assurance or Regulatory Compliance areas

·         Life sciences degree

·         EU or global exposure on clinical studies

Fantastic option for those looking for a role where you can feel involved and able to develop strategy and part of senior management.

Commutable locations: England (London, Surrey, Berkshire, Middlesex, Buckinghamshire)

Salary: £55k - £60k + bonus + benefits

Full details are available upon conversation, apply below immediately and happy to chat further about the opening. You can contact Alastair Shaw at Meet on 0044 203 178 7488 or email – alastair@peoplewithchemistry.com

Associated keywords: Quality Compliance, QA Compliance, GCP Compliance, Clinical Compliance, Manager, Pharmaceutical, Biotech, England, Surrey, Berkshire, Quality Compliance, QA Compliance, GCP Compliance, Clinical Compliance, Manager, Pharmaceutical, Biotech, England, Surrey, Berkshire

A fast growing European Medical Device company is looking to expand their offering into the Middle East
The role is to act as a consultant to the business advising on the Medical Device market in order to assess the possibility and requirements when setting up a registry in Egypt.
Post this point the successful candidate will help in the preparation and submission of regulatory documents, and site start up.
This is an excellent opportunity for a candidate to develop broad experience in a long term piece of work.

ROLE: Clinical Data Manager
TYPE: Contract  / Freelance (length negotiable)
LOCATION: Munich, Germany (potential Flex)

Fantastic, flexible Clinical Data Manager is being sought by this growing pharmaceutical employer to work ideally from their Munich location in Germany. The position is open to discussion around whether full time contract or freelance optons and will see you involved in all data management activities across all associated Phase I-IV projects.

You must be confident in all aspects of data management activities coming from a pharma or CRO background. Any previous lead experience is beneficial, wherher on a global or local level.

Details are available - please contact Alastair Shaw at Meet on 0044 203 178 7488 or email alastair@peoplewithchemistry.com

 

An exciting opportunity has become available for an experienced Clinical Data Manager to join this mid-sized growing CRO offering the opportunity to join a progressive company offering excellent career progression opportunities partnering with some of the world’s largest pharmaceutical companies.

ROLE RESPONSIBILITIES:

Key responsibilities will include, but not be limited to:

·         Perform CRF/eCRF review

·         Co-ordinate and oversee data collection process, tools and deliverables for clinical trials.

·         Partner with study team members, internal functional leaders and clients.

SKILLS DESIRED:

·         3 - 5 years Data Management experience

·         Knowledge of clinical database systems

·         Strong organisational and communicational skills

·         Experience of Clinical Trial systems

Commutable locations: Home or Office based – UK, North, home flex,

Salary: £££  

Full job description and company details are available upon application, apply below. This position is being dealt with by Nick Antonelli at meet, call on + 447880230889 or email directly at nick@peoplewithchemistry.com to discuss in confidence.

Find out more about us at www.peoplewithchemistry.com

Associated keywords:

Data Manager, Clinical Data Manager, Lead Data Manager, Lead Clinical Data Manager, Principal Data Manager, Principal Clinical Data Manager, UK, South, North, London, Home flex, Home, CRO.

 

ROLE: Clinical Data Operations Manager
LOCATION: Zurich, Switzerland
TYPE: Permanent

This opening within a small but global pharmaceutical company is for a Clinical Data Operations Manager to be based from their Zurich, Switzerland HQ. The position will see you with a mix of responsibilities across line management of 2 employees. The position spans across both data management and SAS programming aspects on global studies.

This requires someone with a confident mix of data and programming skills, looking for a varied role with line management responsibilities.

COMPANY BACKGROUND:

This is a global pharmaceutical employer within the medical devices field who continue to grow steadily with excellent security and reputed for their varied positions. With around 700 employees in their Switzerland office they offer an international setting combined with a friendly, personality driven team and office. Established for over 50 years and around 5,500 employees globally they continue to expand with specialism into a range of medical device fields.

ROLE RESPONSIBILITIES:

Joining this Zurich based employer as Clinical Data Operations Manager you have the chance to be part of a motivated, growing data Vascular Intervention division. Within this position you will assume responsibility for:

·         Management of 2 employees within the data / statistics field

·         Support of full data management & compliance areas

·         Some programming input

·         Key contact within the Vascular Intervention (VI) division

This opening is suited to those looking for a challenging, varied yet global opportunity. It isn’t necessary for applicants to have prior line management or medical devices experience so could be suited to those looking to get that step.

SKILLS DESIRED:

·         Excellent data management experience

·         Confident in SAS programming – some exposure

·         Pharma, CRO or Medical Devices employment history

·         Good English and German language skills

·         Ability to lead and manage a small data team

Location: Zurich region, Switzerland

Salary: circa 150,000 CHF package

This opening will be snapped up with its mix of line management, data and programming exposure giving the right candidate engagement and enjoyment on a global capacity.

Contact Alastair Shaw at Meet on 0044 203 178 7488 or email – alastair@peoplewithchemistry.com. You can find out more about Meet and Alastair via their website at www.peoplewithchemistry.com

Associated keywords: Clinical Data Manager, Lead Data Manager, Data Operations, Medical Devices, Pharmaceutical, Switzerland, Zurich, SAS programmer, SAS, Clinical Data Manager, Lead Data Manager, Data Operations, Medical Devices, Pharmaceutical, Switzerland, Zurich, SAS programmer, SAS, Clinical Data Lead

Contract Clinical Data Programmer - Global CRO - UK

 

More details to follow shortly....

ROLE: Clinical Data Project Manager - Top Pharma
LOCATION: West Germany

Fantastic opening to join an industry leading, global pharmaceutical as a Clinical Data Project Manager to be office based from their HQ in West Germany. The position will see you responsible for all data management activities within assigned Clinical Development programmes from Phase I-IV (CDMS, eCRFs, Data Management plans and processes).

Suited to those with a proven Clinical Data Manager background and ability to set project timelines and lead teams.

COMPANY BACKGROUND:

Despite being a globally recognised pharmaceutical this company is still privately owned and retain that family, together feel through their departments. With around 5,000 employees worldwide they have dedicated offices in over 36 countries and are therapeutic leaders within their specialism. Still very much a research based pharmaceutical they continue to pave the way for innovation and blockbuster products for their field.

ROLE RESPONSIBILITIES:

Working from their global HQ in West Germany this opening as a Clinical Data Project Manager will see you operating on an international level across all data activities for critical clinical development programmes. The role will involve:

·         Instructing and giving direction to Clinical Data Managers on assigned projects

·         Input, interaction and management of selected vendors.

·         Monitoring of key milestones across data projects – documentation, systems

·         Improvement and input into data processes & standards improvement

Very well suited to those working at Lead Data Manager level with proven background of running studies, setting milestones and budgets and direction of data teams.

SKILLS REQUIRED:

·         Excellent Clinical Data Manager background

·         Global Pharma employment preferred although CRO considered

·         Leading CDM activities

·         Management of external data vendors

·         Life Sciences Degree

Commutable locations; West Germany (Dusseldorf, Cologne, Aachen, Bonn)

Salary: €negotiable (open to discussion dependent upon experience level)

Full details are available – please apply below to receive all details on the position, you can contact Alastair Shaw at Meet on 0044 203 178 7488 or email – alastair@peoplewithchemistry.com

Associated keywords; Clinical Data Manager, Project Manager, Data Project Manager, CDMS, pharmaceuticals, West Germany, Germany, Clinical Data Manager, Project Manager, Data Project Manager, CDMS, pharmaceuticals, West Germany, Germany

Clinical Project Manager / Clinical Study Manager – HOMEBASED/ STUTTGART - €65,000 to 75,000

EUROS

 

Suitable for; Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager,  Clinical Study Leader, Clinical Project Leader, Clinical Operations Leader, European Study Manager , Global Study Manager, Global LCRA, Lead Clinical Research Associate.

 

We are looking for talented Clinical Project Managers at all levels. This role is open to candidates with all therapeutic  backgrounds and is mainly focussed on Phases 2-3, you will be working on international studies, however we feel we have a strong internal employee development programme, meaning we can consider candidates with European project management experience only.

 

HOMEBASED / STUTTGART

 

Please contact Zoe Benningfield on +44 (0)7896 693960 or email zoe@peoplewithchemistry.com if you would like to know more about this opportunity. This will be 100% confidential.

 

COMPANY BACKGROUND:

 

We are a Top 5 CRO, globally recognised and respected, having won numerous international industry awards . We focus on providing a full service to our Clients that include Pharmaceutical , biotechnology and medical device organisations.

 

HOMEBASED / STUTTGART

 

 

ROLE RESPONSIBILITIES

 

·         Client liaison

·         Managing full project lifecycle from initiation through to close-out.

·         Budge control

·         People management

Please contact Zoe Benningfield on +44 (0)7896 693960 or email zoe@peoplewithchemistry.com if you would like to know more about this opportunity. This will be 100% confidential.

 

SKILLS DESIRED

 

HOMEBASED / STUTTGART

 

2+ years experience in Project management

Global or European experience

CRO experience desirable

Excellent ICH-GCP knowledge

Strong communication skills

 

HOMEBASED / STUTTGART

 

 

Full job description and company details are available upon application, apply below. This position is being dealt with by Zoe Benningfield at Meet, call on + 44 203 178 7488 or +44 7896 693960.

e-mail directly at zoe@peoplewithchemistry.com to discuss in confidence.

Find out more about us at www.peoplewithchemistry.com

 

 

 

 

KEY WORDS

 

CPM, Director, Clinical, Programme, Program, Suite, Study, Studies, Trials, Manage, Matrix, International, Team, CRO, Pharma, Pharmaceutical, Clinical Research Organisation, Organization, Clients, Clinical Operations manager, , Sponsor, clinical project manager, project manager, global clinical project manager, global project manager, pharma, project manager, Clinical Operations manager, project manager, Clinical operations  manager, global clinical project manager, global project manager, global project leader, clinical project manager, global clinical project manager, PM, CPM, operations manager, study operations manager, global study operations manager, study manager, clinical study manager, global study manager, Clinical Operations manager, clinical project manager, project manager, study manager, clinical study manager, global study operations manager, PM, CPM, proj manager, clin proj manager, project manager, global project manager, Germany, Munich

This client is a TOP 3 Pharmaceutical and Healthcare company. They are a leading organisation with offices in over 20 countries and on-going clinical studies in over 45 countries. This awarding winning company is looking to expand its Enrolment division in Germany. Outsourced directly to a Top 5 Pharmaceutical company (Sponsor), this position is suitable for Clinical Trial Educators, Clinical Study Nurse, CRA, CRAII, Senior CRA, Clinical Trial Coordinator.

HOMEBASED – Germany wide.

Please contact;

Vishal Sharma on +447794411452 or email Vishal@peoplewithchemistry.com If you would like to know more about this opportunity. This will be 100% confidential. Find out more about us at www.peoplewithchemistry.com

Responsibilities

·         Patient enrolment and patient recruitment

·         Ensure up to date knowledge of the indication is maintained

·         Be responsible for scientific meetings

·         Build and maintain strong relationships with site.

·         Represent the sponsor at investigator meetings

HOMEBASED – Germany wide. This can be home based or office based (Berlin). Regular travel is required.

Please contact;

Vishal Sharma on +447794411452 or email Vishal@peoplewithchemistry.com If you would like to know more about this opportunity. This will be 100% confidential. Find out more about us at www.peoplewithchemistry.com

 

Qualifications

·         Medical or life science education 

·         Minimum 3 years of experience in clinical research, Solid knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

·         Fluent English, Germany

·         Excellent interpersonal and communication skills, independent

 HOMEBASED – Germany wide.

Please contact;

Vishal Sharma on +447794411452 or email Vishal@peoplewithchemistry.com If you would like to know more about this opportunity. This will be 100% confidential. Find out more about us at www.peoplewithchemistry.com

 

CRA, Clinical Research Associate, Clinical Monitoring Associate, Clinical Monitor, CRO, early phase, late phase, study start-up, study initiation, clinical trial educator, patient  enrolment, patient retention.,routine monitoring, study close out, clinical site management, ICH-GCP, co-monitoring, oncology, cardiology, study close out, clinical trial educator, patient  enrolment, patient retention. clinical site management, ICH-GCP, co-monitoring, oncology, cardiology, CRA, Clinical Research Associate, Clinical Monitoring Associate, Clinical Monitor, Clinical trainer, clinical trial educator, patient  enrolment, patient retention.