World Science Jobs

Study Co-ordination Manager – Cambridge

MRC Epidemiology Unit, Cambridge

The Medical Research Council Epidemiology Unit is based within the new Institute of Metabolic Science (IMS) building at the Addenbrokes site, Cambridge, and studies the genetic and environmental determinants of obesity, type 2 diabetes and related metabolic disorders. Due to the expansion of the Unit we are seeking to recruit the following position: Study Co-ordination Manager

(Ref: EPID08/592)
36 hours per week

This exciting post gives you the opportunity to oversee the co-ordination of clinical research projects and clinical trials across all the scientific programme areas of the Unit.You will liaise with Principal Investigators and members of the Functional Group to implement and support the processes of study co-ordination.

You will have the opportunity to lead on the continued development of these processes and be responsible for ensuring that the Units studies and trials adhere to the latest research governance procedures and practices.You will manage the study co-ordination and support team as well as offer support to other members of the Unit (such as CDFs and PhD students) in their study co-ordination role.

We seek someone with a degree or equivalent in a relevant biological, clinical science or health related research area together with considerable senior management experience in an NHS/medical research/academic clinical research environment. Experience of running large multi-centred clinical trials or studies and a thorough understanding of good clinical research practise and the latest research governance are essential, as is experience of line management for a team of staff and a sound knowledge of IT systems in relation to study co-ordination.

If you would like an informal discussion regarding both positions, please contact Susie Hennings on 01223 330315, email: susie.hennings@mrc-epid.cam.ac.uk

This position offers a flexible pay and reward policy, 30 days annual leave and optional membership of MRC’s final salary pension scheme.

Applications for this roles must be made online at http://jobs.mrc.ac.uk inputting the appropriate reference. If you do not have internet access or experience technical difficulties please call 01793 301260.

Closing date: 3 November 2008.

For further information about the MRC visit www.mrc.ac.uk

The Medical Research Council is an Equal Opportunities Employer

Producer Project Manager Interactive Media Developer. Keywords: Flash, Action Script, AS3, C#, .NET, C++, PHP, Python, Java Hertfordshire Essex
A fantastic opportunity has a risen for a Project Manager / Producer to help drive the development forward of new cutting edge interactive media projects. Joining a world renowned and highly creative media agency in Hertfordshire, your key role will be to help provide innovative strategies and solutions for world leading healthcare organisations.

Working with a team of designers and software developers you will help identify new and creative solutions for clients, whilst ensuring deadlines are met and production of all interactive projects are to a high standard.

The successful candidate will be involved in research and development of new technologies, looking to incorporate these into future projects.

This is an amazing opportunity to work alongside an award winning team comprising of 3D designers, and highly experienced professionals in the fields of special effects and the latest 3D technologies. This role would be ideal for an experienced Flash Developer, with management/team leading experience hoping to take their career to the next level. If you enjoy assisting with business development projects, have the technical know how and can work with various project managers on a weekly basis.. Then I want to hear from you!

Rewards include a fantastic salary and benefits package including: company pension scheme, staff bonuses and private healthcare. You will be welcomed into a fast paced working environment, where creative thinking is encouraged and results are rewarded.

For more information on this role you can contact Kieron Mc Daid at Paramount Recruitment on 0121 616 5157

Keywords:
C#
.NET
C++
PHP
Python
Java
SWF Studio or ADOBE AIR

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Paramount Clinical Research: Clinical Data Manager, East Anglia

Are you an experienced Clinical Data Manager looking for a rewarding position and career progression?

One of the largest clinical data management consultancies in Europe is looking for a Clinical Data Manager to join their established team in East Anglia. This suburb opportunity is ideal for an enthusiastic Clinical Data Manager looking for development and career progression!

As the senior clinical data manager (CDM), you will be expected to lead and coordinate all aspects of clinical trials data, working on phases I to IV studies. You will insure that all tasks are carried out efficiently according the clients specific budgets and deadlines, maintaining constant communication with the clients via telephone, email and video conferences. You will attend information and presentations on behalf of the clinical data management team, these will include workshops and project planning meetings as appropriate. Your technical duties will include identify errors and inconsistencies in CRF data and ensuring their resolution in order that databases can be declared clean and locked according to ICH GCP standards.

As the senior clinical data manager (CDM), you will be expected to lead and coordinate all aspects of clinical trials data, working on phases I to IV studies. You will insure that all tasks are carried out efficiently according the clients specific budgets and deadlines, maintaining constant communication with the clients via telephone, email and video conferences. You will attend information and presentations on behalf of the clinical data management team, these will include workshops and project planning meetings as appropriate. Your technical duties will include identify errors and inconsistencies in CRF data and ensuring their resolution in order that databases can be declared clean and locked according to ICH GCP standards.

In return you will receive a generous salary, competitive benefits package and an outstanding relocation package!!!

For further information or to apply to this role, please contact Vicky Pitt on 0121 616 5021.

KEYWORDS: Clinical Data Manager , CDM , Senior, Clinical Research Organisation ,

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Paramount Clinical Research: Experienced Statistician- Homebased

An outstanding opportunity has arisen for an experienced biostatistician to work for in an internationally renowned Clinical Research Organisation, with the option of being homebased. This is an ideal opportunity for a statistician looking for a challenging and exciting role.

As the Biostatistics Team lead you will contribute to the management of the biostatistics team, managing the initial hiring and training of staff, as well ensuing their ongoing development plans. You will be expected to effectively assign takes, ensuring that client’s deadlines are met and to oversee all other biostatistics aspects of clinical trials. In addition you will be seen as one of the main biostatistics contacts for the departments and represent the company in meetings with both clients and regulatory agencies. As the biostatistics team leader your technical duties will include: Producing sample size calculations, inputting into study design and statistical considerations, during protocol development. You will review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contribute to writing appropriate protocol sections are also required and you will act as the randomization statistician on selected projects.

Successful candidates should have a Bsc in statistics or related discipline. Ideally 3 years + in a clinical research organistion or pharmaceutical company as a statistician, with people management experience is also required. A sound knowledge of SAS and complex statistical techniques are essential coupled with excellent communication and interpersonal skills!

In return you will receive an excellent salary and a competitive benefits package, with the option of being home based!

This is a outstanding opportunity for an experienced statistician to develop their career in a globally renown company!

For further information or to apply to this role, please contact Vicky Pitt on 0121 616 5021.

KEYWORDS: SAS. SAS Programmer, Statistician, Biostatistics, Statistics ,Bio-Statistics, Bio-Statistician Biostatistician Clinical Research organistion , CRO , Pharmaceutical

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

-Company: 

This UK arm of a global healthcare company is devoted to discovering new medicines and technologies, as well as new ways to manage health. Their diverse range of products spanning from nutritional products to medical devices to pharmaceutical therapies. 

-Role: 

This is an excellent opportunity for a medically qualified doctor, with full GMC registration and some previous pharmaceutical experience to undertake a senior medical advisor role within a leading pharmaceutical organisation. The purpose of this role is provide scientific and clinical support to drive forward the UK business. 

Key Responsibilities Include: 
*Assist and advise Marketing Department in the preparation of promotional and training material 
*Ensure all materials are fully compliant with the ABPI Prescription Medicines Code of Practice 
*Provide support and training to the sales force and other departments as necessary 
*Provide scientific and clinical input into key commercial initiatives as required 
*Establish and develop strong relationships with key external customers including KOLs in assigned therapeutic areas 
*Deliver scientific presentations to KOLs and/or leading clinical units 
*Develop and maintain in-depth knowledge of the company’s products, relevant therapeutic areas and the structure and workings of the NHS 
*Provide support as required to Medical Information, Regulatory Affairs, Pharmacovigilance 
*Support the Clinical Research Department (and/or CROs acting on behalf of the company in the management of phase IIIb/IV clinical trials as appropriate 
*Lead and/or provide representation on internal cross functional teams 

-Qualifications: 

The ideal candidate will have/be: 
*Fully registered physician with GMC 
*Medically qualified with post-registration clinical experience 
*Previous clinical experience in the area of rheumatology is preferred 
*Good presentation skills 
*Good project management skills 
*Excellent interpersonal skills 
*Confident, Enthusiastic, Computer literate 
*Able to operate as a flexible team player 
*Good presentation skills 
*Good project management skills 
*Excellent interpersonal skills 
*Confident 
*Enthusiastic 
*Computer literate 
*Able to operate as a flexible team player 

-Additional Information/How to Apply: 

For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online using the link below. 

ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics, Business Development…etc. 

If this role is not for you, but you would like to hear about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. 

www.proclinical.co.uk

-Company: 

Our clients are an international, research and development oriented, pharmaceutical company. They concentrate on creating innovative medicines for the international pharmaceutical market. 

In the past, this company has been successful in genomic drug discovery, determining the relationships between genes and certain diseases. Moving forward, their research and development division focuses its resources on therapeutic areas such as prostaglandins, enzyme inhibitors, neuroscience and cellular signalling. In doing this, the company seek to develop medicines that truly serve the needs of patients. 

-Role: 

This is an excellent opportunity for an established Clinical Research Manager to undertake both an operational and a strategic role, within a small but growing international pharmaceutical company. 

Role Summary: The Project Director (PD) is responsible for all aspects of project(s) for the company, including the functional management and supervision of the project team members. 

The PD will take a responsible, leadership role in planning and implementing of clinical project(s), so as to meet corporate objectives, by managing and overseeing the internal project team. In addition to this, they will work closely with key opinion leaders and external consultants, under the guidance of the clinical development management team. The PD will also contribute to the company’s global clinical development management team. 

-Qualifications: 

The ideal candidate will have: 
* Post graduate degree in life science 
* Substantial prior experience in Clinical Research and Clinical Project Management 
* Clinical science and planning experiences in pharmaceutical companies. 
* Prior experience in the Urology therapeutic area is preferred, but not essential 

-Additional Information/ How to Apply: 

Occasional travel in Europe may be required 

For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online using the link below. 

ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics…etc. 

If this role is not for you, but you would like to hear about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. 

www.proclinical.co.uk

-Company: 

Our clients are an expert Regulatory, Clinical Research and Quality Services consultancy to the healthcare industry worldwide. This company’s focus is on the planning and execution of product development programmes, including a full range of regulatory support services and the management and monitoring of early phase clinical trials. 

-Role: 

This is an office-based full-time position. We are looking to find someone who may be interested in project management in due course, but is interested in monitoring for now. We may also consider part-time where the individual was able to work 2-4 full days per week 

The Senior Clinical Research Associate will report to the Directors of the company, but may also report to or work closely with the Clinical Project Manager and Clinical Research Executive where they are managing a project to give support with study monitoring and other technical matters. 

Responsibilities of the role will include provision of clinical research services (study monitoring, provision of protocols, CRF review, start-up to close-down of study sites etc), training services and some business development activities. 

-Qualifications: 

The Senior Clinical Research Associate will have the minimum qualifications of a life science degree (BSc). 

They will have competent word processing skills (including use of the MS Office applications Word, Excel, Powerpoint and Outlook) and will have relevant experience from working as a Clinical Research Associate in a pharmaceutical / healthcare product development environment. Ideally, the Senior Clinical Research Associate will have several years experience in similar positions. 

-Additional Information/ How to Apply: 

For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online using the link below. 

ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics, Business Development…etc. 

If this role is not for you, but you would like to hear about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. 

www.proclinical.co.uk

-Company: 

Our clients are an innovative full-service Contract Research Organisation (CRO), with a reputation for project excellence, expertise in clinical and data management, and risk mitigation, balancing the personal touch of a small firm, with the full service and global presence of some of the largest CROs. 

-Role: 

We are looking for a Senior Project Manager to be based in Marlow, Buckinghamshire. This person needs to possess strong global project management experience, preferably within a CRO, due to the extensive financial management responsibilities included in the role description. 

This person will manage large trials with sites in approximately 15 countries, requiring the job holder to have great cultural sensitivity, ability to manage trials in different time zones, and experience with regulator submissions in different countries. 

Role Summary: Project Management of assigned projects in accordance with Sponsor and/or company SOPs, ICH-GCP guidelines, local regulations and any additional sponsor requirements. All activities are performed in the interest of subject safety and vigilance against fraud. Leadership and management of junior personnel and participation in departmental and project team meetings will also be required. 

Key Responsibilities will include: 
* Project Analysis and Management – 25% 
* Project Team Leadership – 25% 
* Project Guidelines and Communication – 20% 
* Internal Communicate – 20% 
* External Communications and Business Development – 10% 

-Qualifications: 

The ideal candidate will have: 
* Degree in life science or computing, or nursing qualification, or other equivalent experience or education e.g. laboratory experience 
* Extensive Clinical Research experience inclusive of Clinical Monitoring 
* Experience with medical terminology is required 
* Experience in a variety of therapeutic areas preferred 
* Full UK Driving license and a valid passport 
* Ability to use MS office and company specific software 
* Ability to use and communicate the appropriate use of web based portals, and electronic data capture software for applicable projects 
* Awareness of the drug development process, including regulatory requirements and ICH-GCP guidelines 
* Budgetary experience is essential 
* Professionalism and integrity 
* Ability to work as a proactive team member and team leader 
* Excellent organisation skills, a thorough approach to work and good attention to detail 
* Excellent communication skills 
* A flexible approach to work 

-Additional Information/How to Apply: 

Although, predominantly office based, the role could offer some flexible home working for the right candidate 

The job holder must have the ability to travel routinely during the working week, with possible international 

For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online using the link below. 

ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics, Business Development…etc. 

If this role is not for you, but you would like to hear about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. 

www.proclinical.co.uk 

-Company: 

Our clients are one of the largest and well respected pharmaceutical companies across the globe. They excel in the areas of Pharmaceuticals, Vaccines and Diagnostics, Generics and Consumer Health products. 

This company is committed to the development of innovative medicines, with a particular focus on Cardiology and Oncology, amongst other therapy areas. They currently have 75 products in their pipeline, which is one of the strongest in the industry. 

-Role: 

Do you want to lead a part of a truly dynamic, multidisciplinary team, with the opportunity to work on a truly innovative and promising pipeline of medicines? You will use your superior communication and influencing skills to develop working relationships with KOLs, by providing state of the art scientific information relating to Cystic Fibrosis. 

Job Purpose: Provide high quality, credible scientific support and therapeutic product knowledge to customers and account teams 

-Qualifications: 

The ideal candidate will have: 
* The ability to understand, process and communicate scientific information to a high standard 
* Excellent influencing and networking skills 
* Excellent communication skills 
* Energy and enthusiasm with significant commercial acumen 
* A true team player 
* Life Sciences background 
* Prior experience in a similar role 

-Additional Information/How to Apply: 

For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online using the link below. 

ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics, Business Development…etc. 

If this role is not for you, but you would like to hear about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. 

www.proclinical.co.uk 

-Company: 

Our clients are one of the largest and well respected pharmaceutical companies across the globe. They excel in the areas of Pharmaceuticals, Vaccines and Diagnostics, Generics and Consumer Health products. 

This company is committed to the development of innovative medicines, with a particular focus on Cardiology and Oncology, amongst other therapy areas. They currently have 75 products in their pipeline, which is one of the strongest in the industry. 

-Role: 

Due to an internal promotion, a vacancy has arisen for a Medical Development Manager (MDM) in the Oncology Business Unit. In this role, the person will manage all aspects of a six strong Medical Development Advisor (MDA) team who support the entire oncology portfolio. 

The Oncology Business Unit (BU) is in a period of unprecedented expansion and growth with a pipeline that is the envy of the industry. The MDA team is key to driving the development of our marketed brands and our pipeline compounds and the MDM is a pivotal role within the BU. 

-Qualifications: 

The ideal candidate will have: 
* Excellent leadership skills and preferably experience of managing high performing teams 
* Strong influencing and networking skills 
* Strong strategic thinking and decision making abilities 
* Strong medical/scientific background preferably with a higher degree 
* The ability to process and communicate large amounts of complex medical and clinical data 
* Excellent communication skills 
* Commercial acumen 
* Proven track record of KOL management and development 
* Energy and enthusiasm and the motivation to lead a field based team of medical experts 
* Experience of working across sales, marketing and medical functions 
* Experience of working within the ABPI Code of Conduct 

-Additional Information/How to Apply: 

The position is field based but will require regular time in the office and it will report directly to the Oncology Medical Director 

For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online using the link below. 

ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics, Business Development…etc. 

If this role is not for you, but you would like to hear about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. 

www.proclinical.co.uk

Paramount Recruitment: Standardization SAS Programmer, UK 

A fantastic opportunity has arisen for a Data Integration & Standardization SAS Programmer; to join a leading Clinical Research Organisation is their Berkshire , Manchester or Dublin Office. This fantastic company is renowned for the excellent training and support that they offer all their employees, making this a fantastic opportunity for a motivated sas/statistical programmer looking to progress their career. 

As the manager of Data Integration & Standardization, you will be responsible for statistical aspects of clinical trials, this will include statistical analysis/programming and designing/implementing standardized clinical trial solutions. You will be expected to receive load and verify structure of external data, creating CDISC complaints and sponsor defined data structures. You should be able to commutate on a variety of levels as you will be liaising with a variety of contacts with the Clinical Data Management and Biostatistics departments. In addition you should have excellent interpersonal skill as you will be expected to work both alone and as a member of a team. 

Successful candidates should have a BSc in a computer related discipline. Ideally 2 years + working within a clinical research organisation or pharmaceutical company. You should have a sound knowledge of ICH- GCP, CDISC procedures and SAS programming. Good communication skills are an advantage. 

This is a fantastic role for a motivated individuals looking to progress their career to the next level 

In return you will receive a generous salary and competitive benefits package including: Health care, pension, life insurance, flexi time and much more!! 

Key words: Biostatistics, Statistician, Clinical, Programming, Clinical trails, SAS, clinical data. 

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Paramount Clinical Research: Biostatistics Manager – Hampshire 

A leading global Clinical Research organisation is seeking a Biostatistics Manger to join their team in the Hampshire office. This is an excellent opportunity to join a company, that despite having offices in over 30 countries world wide, strives to provide a supportive and respectful environment for all its employees. 

As the Biostatistics manager your role will involve organizing multiple projects, managing both your own work and managing a team. You will be the main statistical contact for clients, so will need to be able to communicate on a variety of different levels. In conjunction to this you will be working with SAS programmers and should be familiar with a variety of statistical packages including StatXact and Nquery. 

Candidates should have a PhD/MSc in statistics or related discipline and excellent communication skills, with an ability to communicate with people across the globe. Knowledge of SAS and experience working within a Clinical Research Organization, Pharmaceutical or healthcare company is essential. A positive attitude and ability to work well with other is also required. 

In return you will receive a generous salary with a competitive bonus package. 
This is an outstanding opportunity for a Biostatics manger to join a leading CRO, with the opportunity of career progression. Your will also be rewarded by knowing your company takes pride in the exception quality of their work. 

For further details about this opportunity contact Victoria Pitt on +44(0)121 616 5021 

KEYWORDS: , Programmer, SAS, Statistician, Biostatistics, Statistics ,Bio-Statistics, Bio-Statistician Biostatistician, , Clinical research Organization, Clinical Research, Clinical Study, Pharmaceuticals, 

Paramount Recruitment Limited provides services as an agency and an employment business. 
We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. 

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Paramount Clinical Research: Clinical Data Manager, North of Cambridge 

One of the largest clinical data management consultancies in Europe is looking for a Clinical Data Manager to join their established team in East Anglia. This suburb opportunity is ideal for an enthusiastic Clinical Data Manager looking for development and career progression! 

As the senior clinical data manager (CDM), you will be expected to lead and coordinate all aspects of clinical trials data, working on phases I to IV studies. You will insure that all tasks are carried out efficiently according the clients specific budgets and deadlines, maintaining constant communication with the clients via telephone, email and video conferences. You will attend information and presentations on behalf of the clinical data management team, these will include workshops and project planning meetings as appropriate. Your technical duties will include identify errors and inconsistencies in CRF data and ensuring their resolution in order that databases can be declared clean and locked according to ICH GCP standards. 

As the senior clinical data manager (CDM), you will be expected to lead and coordinate all aspects of clinical trials data, working on phases I to IV studies. You will insure that all tasks are carried out efficiently according the clients specific budgets and deadlines, maintaining constant communication with the clients via telephone, email and video conferences. You will attend information and presentations on behalf of the clinical data management team, these will include workshops and project planning meetings as appropriate. Your technical duties will include identify errors and inconsistencies in CRF data and ensuring their resolution in order that databases can be declared clean and locked according to ICH GCP standards. 

In return you will receive a generous salary, competitive benefits package and an outstanding relocation package!!! 

For further information or to apply to this role, please contact Vicky Pitt on 0121 616 5021. 

KEYWORDS: Clinical Data Manager , CDM , Senior, Clinical Research Organisation , 

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. 

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Flame Pharma – Clinical Research – Pharmacovigilance Manager Job – Berkshire:
Job Summary
This excellent Pharmacovigilance Manager opportunity will report directly to the Head of Pharmacovigilance for our client, an innovative and progressive CRO. If you have proven pharmacovigilance/drug safety experience, coupled with line management experience in a CRO or Pharmaceutical company, then we would encourage you to contact us.
Job Title
Pharmacovigilance Manager
Background
Utilising your awareness of global regulatory and pharmacovigilance environments, the Pharmacovigilance Manager will be responsible for the pharmacovigilance activities for assigned studies whilst acting as line manager for Pharmacovigilance Executives and Administrators. You will also be instrumental in business development and client liaison.
Key Responsibilities
• Generates and updates Serious Adverse Event Management Plans.
• Generates instructions for the completion of Serious Adverse Event forms.
• Configures and validates safety systems for specified projects.
• Manages and processes expeditable Serious Adverse Event Reports.
• Reviews and updates Serious Adverse Event databases and tracking systems as required.
• Reviews Serious Adverse Events for completeness, accuracy and appropriateness for expedited reporting as required.
• Reviews patient narratives.
• Reviews the coding of Serious Adverse Events.
• Generates queries for sites to obtain required follow-up information as required.
• Reviews reporting of expeditable Serious Adverse Events to clients, regulatory authorities, ethics committees, investigators and project team personnel, if required, within study specified timelines.
• Reviews letters for submissions on expedited safety reports.
• Provides independent QC of AE reports for members of the pharmacovigilance group.
• Works with the Biometrics department on reconciliation of safety databases.
• Assists in the validation and implementation of upgrades to the PV Works™ safety database, in conjunction with COMPANY IT department and the vendor.
• Assists in the generation and review of proposals and costings for pharmacovigilance business.
• Presents safety capabilities at business development presentations to clients.
• Reviews Clinical Trial Protocols, Case Report Forms and Serious Adverse Event Reporting forms.
• Attends and presents on Serious Adverse Event reporting at Investigator Meetings.
• Participates in COMPANY project teams and provides training on Serious Adverse Event reporting.
• Attends client meetings and liaises with clients where appropriate.
• Reviews cumulative safety data for submission to DSMBs, regulatory authorities or clients as required.
• Manages the set-up of, and provision of data to, Safety Committees/Drug Safety Monitoring Boards.
• Assists with preparation and attendance at client or regulatory authority audits.
• Reviews pharmacovigilance budgets for allocated projects, identifies out-of-scope activities and works with Project Management and Business Development to process change orders.
• Assists with the recruitment of new staff to Pharmacovigilance Department.
• Trains and mentors new employees concerning Serious Adverse Event reporting.
• Assists with the management of the pharmacovigilance group concerning project allocation and resourcing.
• Assists with the generation and review of SOPs and WPGs.
• Builds and maintains good relationships across functional units and COMPANY affiliates.
• Other duties as assigned by management.
Qualifications and Experience
• Extensive experience in the CRO or pharmaceutical industry including proven pharmacovigilance experience.
• Proven line management experience.
• Awareness of global regulatory environment.
• Good awareness of global pharmacovigilance environment.
• Experience of a variety of safety databases.
Benefits
With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary in the region of 30000-40000 plus bi-annual bonus scheme.
Key Words
Pharmacovigilance, Drug Safety, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Berkshire
The position will be based in Berkshire.
For further information and to apply for this position please contact Flame Pharma on 0800 085 0858.