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Job Search Results: Jobs 1 - 10 of 16  View Titles Only  Page 1 of 2
 
Title   Company Name     Location   Date  
Senior Clinical Research Associate 

  Hays Pharma    All   10/7/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software, life sciences  
Education: Bachelors   Position type: Full Time Employee  Experience: 3 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Research  
Description:
Senior Clinical Research Associate


PURPOSE OF THE JOB

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP
Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of systems and procedures as appropriate.
Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Provide a benchmark for acting according to company values and act as a positive promoter


 
Requirements:
JOB FUNCTIONS/RESPONSIBILITIES

Knowledgeable of Clinical Research SOPs/WPs, ICH-GCP and appropriate regulations.
Knowledgeable of clinical systems
Recruitment of investigators.
Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following
- Identify investigators.
- Help, when requested, in preparation of Regulatory submissions.
- Design patient information sheets and consent forms.
- Co-ordinate documents translation, verification and back translations where required.
- Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
- Placement and initiation visits.
- Conduct regular monitoring visits in accordance with site monitoring SOP/Sponsor site monitoring SOP, as appropriate
- Maintain all files and documentation pertaining to studies.
- Motivate investigators in order to achieve recruitment targets.
- Complete accurate study status reports.
- Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
- Keep the project manager regularly informed.
- Process case record forms to the required quality standards and timelines.
- Deal with Sponsor generated queries in a timely manner.
- Ensure the satisfactory close-out of investigator sites.
- Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
- Ensure correct archiving of files on completion of a study.
- Maintain patient and sponsor confidentiality.
- Assume additional responsibilities as directed by Associate Clinical Project Manager/Clinical Project Manager (CPM).
- Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a CPM/Associate Clinical Project Manager.
- Co-ordinate and/or participate in feasibility studies for new proposals, as required.
Be cost effective.
Participate in mentoring and training new staff.
Assist with marketing the company if and when appropriate.

QUALIFICATIONS/EXPERIENCE REQUIRED

Medical/science background and relevant experience.
Ability and willingness to travel at least 50% of the time (international and domestic fly and drive)
Ability to review and evaluate clinical data arising from aptitude and have the required level of experience in Clinical Research.
Computer literacy required.
Foreign language skills desirable.
Current full driving licence essential.
Good oral and written communication skills.





 
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Clinical Research Associate II 

  Hays Pharma    All   10/7/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time  Experience: 2 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Regulatory Affairs  
Description:
My client, a global leading organisation within the pharmaceutical industry, is presently seeking a Senior CRA to work over in Berkshire.

My client is looking for candidates to perform trial initiation, monitoring and close out activities in Phase II-IV clinical research, managing study site activities to ensure clinical data integrity in line with company and regulatory guidelines, and providing clinical and technical support to other CRAs and administrative staff.

As Senior CRA you will provide clinical and technical support, conduct co-monitoring/training visits and assist with protocol review, CRF and informed consent development, plus study start up activities. Where required, you will be the primary client contact for project related activities, and also act as mentor for CRAs.

 
Requirements:
Reporting to project leader, you may assume the role of a Lead CRA on projects by providing direction to the project team, coordinating monitoring activities, developing CRFs and acting as liaison between monitoring and other functions.  
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Clinical Project Manager 

  Hays Pharma    All   10/7/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing  
Education: Bachelors   Position type: Full Time  Experience: 4 years 
Area(s) of expertise desired: Clinical Research  
Description:
Managing all aspects of studies or study programmes allocated by the GM or SPM and to be responsible for ensuring control of allocated study budget.

 
Requirements:
Responsibilities include:

To participate in the preparation of clinical development plans
To manage clinical studies
To ensure that studies are performed and completed in accordance with the pre-defined budget, timelines and quality specifications
To participate in CRO evaluation and selection and be responsible for making selection recommendations to SPM/DGM
To coordinate the establishment of service provider contracts.
To ensure that a safety reporting system is in place and that safety reports are provided to the Safety Department in a time manner
To ensure that studies are conducted in accordance with EU GCP requirements and relevant company SOPs
To produce or co-ordinate the preparation of study protocols  
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CRA II 

  Hays Pharma    All   13/7/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research  
Description:
Our client, a worldwide Contract Research Organization, is seeking for its branch in Milan a Senior CRA to Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP. Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the Company"s systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues and acting according to Company"s values and as a positive promoter.

 
Requirements:
For this role is required significant experience as a CRA for at least 18 months.

This is for an international company- please provide all CV's in English format
Thankyou  
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Manufacturing 

  Fellen Project    All   2/8/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education: Masters   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Manufacturing/Production  
Description:
Our client, a manufacturing company. has an immediate opening for cost accountant with 4-year accounting degree and a minimum of 2-4 years experience in a manufacturing process cost environment. Responsibilities include preparation of manufacturing budgets, month-end close, standard cost and variance analysis, financial analysis, and inventory reconciliation. The successful candidate should have the ability to work with various levels of management and a working knowledge of Microsoft Excel. JD Edwards or other MRP package experience preferred. Salary 45-55K. DOE  
Requirements:
Our client, a manufacturing company. has an immediate opening for cost accountant with 4-year accounting degree and a minimum of 2-4 years experience in a manufacturing process cost environment. Responsibilities include preparation of manufacturing budgets, month-end close, standard cost and variance analysis, financial analysis, and inventory reconciliation. The successful candidate should have the ability to work with various levels of management and a working knowledge of Microsoft Excel. JD Edwards or other MRP package experience preferred. Salary 45-55K. DOE  
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VP R&D 

  tema    Tel Aviv Area   24/9/2007 
Category: Medical Management  
Education: Doctorate   Position type: Full Time Executive  Experience: 10 years 
Area(s) of expertise desired: Cell Biology, Cell Culture, Molecular Biology, Project Management, Protein Chemistry, VP R&D  
Description:
A company that has developed breakthrough technology in the field of freezing and drying blood (red cells) for blood transfusion. The company is located in Rehovot area.  
Requirements:
5- 10 years of managing in the field of Lab managing or R&D in the field of blood.
2nd or 3rd degree in, fields, such as physiological, protein, hematology, Membrane.
Experience & background in hematology.
Understanding blood in the Molecular level.
Managing groups of about 5-10 employees at least.
Experience in FDA & Regulation processes.
English Native speaker Advantage!!!
 
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Clinical Research Associate/Senior Clinical research associate- office/home based 

  Hays Pharma    All, Izrael (anywhere)   6/11/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Clinical Research  
Description:
JOB FUNCTIONS/RESPONSIBILITIES:

Recruitment of investigators.
Co-ordinate all the necessary activities required to set up and monitor a study, including the following:
Identify investigators
Help, when requested, in preparation of regulatory submissions
Design patient information sheets and consent forms.
Ensure timely submission of protocol/consent documents for ethics/IRB approval.
Placement and initiation visits.
Conduct regular monitoring visits in accordance with site monitoring SOP / Sponsor site monitoring SOP, as appropriate
Maintain all files and documentation pertaining to studies.
Motivate investigators in order to achieve recruitment targets.
Complete accurate study status reports.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Keep the project manager informed.
Process case record forms to the required quality standards and timelines.
Deal with Sponsor generated queries in a timely manner.
Ensure the satisfactory close-out of investigator sites.
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
Ensure correct archiving of files on completion of a study.
Co-operate with sponsor and/or QA personnel in the conduct of QA audits.
Maintain patient and sponsor confidentiality.

 
Requirements:
Cost effectiveness.

To participate in training new staff as appropriate.

Assist with marketing the company if and when appropriate.



QUALIFICATIONS/EXPERIENCE REQUIRED:

Medical/science background and relevant experience.

Ability and willingness to travel at least 50% of the time.(lnternational and domestic: fly and drive).

Ability to review and evaluate clinical data.

Computer literacy desirable.

Foreign language skills desirable.

Current full driving licence essential.

Good oral and written communication skills.



 
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Medical Advisor-Greece 

  Hays Pharma    Worldwide   4/11/2008 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time  Experience:  
Area(s) of expertise desired:  
Description:
Medical Advisor opportunity has arisen within a blue-chip pharmaceutical company in Athens. This is a highly interactive role, demanding effective strategic thinking and planning skills and the ability to network, teamwork and build influential relationships with your colleagues, customers and external opinion formers.
As a Medical Advisor you will provide a specialist role in a number of therapeutic areas. You will work closely with your commercial colleagues to provide pro active input into the strategic management of the business, jointly agreeing, developing and implementing strategic direction within key therapeutic areas, allowing commercial aims and ambitions to be met.

The role requires a good understanding of clinical development processes and of the changing health care environment


Accountabilities

Providing authoritative opinion on medical, legal and regulatory matters to support your colleagues across the UK, enabling them to comply with the relevant statutory requirements (e.g. Code of Practice, Medicines Act, and EU Directives).
Provision of pro active input to the development of business strategy.
Effectively developing relationships with key influencers and external organizations to ensure that the company retains a leading voice in the pharmaceutical industry.

Coordinating and utilizing specialist knowledge with brand aligned colleagues in formulating and implementing short and long term medical strategy for optimal commercial benefit.
Working closely with regulatory, commercial and clinical colleagues on pre-launch planning, including strategic evidence planning and generation.
Influencing clinical research strategies in support of market needs
Provide medical information
Knowledge of the clinical practice, care pathways, key competitors, etc. and input where required into study allocation process.
Input into a development of local protocols, patient information customer-initiated research projects (CIRPs) and named patient programmes.
Input into reviews and sign off of abstracts, reports and publications.
Pro active input into European Medical meetings to ensure strategy is supported.
Review and sign-off Regulatory documents as required.

 
Requirements:
Qualifications/Experiences

A registered medical doctor.
Expert therapy knowledge in a broad range of therapeutic areas,
Continuous record of career achievement through clinical development and/or medical affairs positions.
Previous industry experience would be beneficial
A good understanding of the changing health care environment.

 
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CRA 

  Hays Pharma    Tel Aviv Area   4/11/2008 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time  Experience:  
Area(s) of expertise desired:  
Description:
Our client, a global CRO is looking for Clinical Research Associates with minimum 1 year of experience join a professional team.

The responsibility of a Clinical Research Associate II (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with companys SOPs. As Regional CRA or Primary CRA (on smaller studies) responsibilities will include managing clinical monitoring activities in addition to the ownership of investigator sites, including investigator/site selection, collating regulatory documentation, initiation and monitoring (source data verification, drug accountability and data collection) in accordance with ICH GCP guidelines.

Responsibilities

Perform clinical trial initiation, monitoring and closeout activities.
Assists with study start-up activities, site selection, and pre-study activities to identify and evaluate potential investigators.
Assists in site evaluation and reports to Lead CRA / Project Leader as appropriate.
Assists in submission of documents to the Ethics Committees, when required.
Participates in study specific training.
Assists with the preparation and coordination of investigator meetings and attends meeting.
Provide status updates of pre-study and initiation activities to Lead CRA / Project Leader.
Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures.
Assists in development of patient enrollment strategies with the project team and study site coordinator
Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with the project plan.
Manages study site activities and provides ongoing updates of site status to Lead CRA / Project Leader.
Maintains tracking records for assigned sites such as tracking of status and source document review per patient.
Completes study site closeout visits.
Assists with Project specific administrative activities as a member of the project team.
Ensures site registration in Investigator Database.
Increases knowledge of drug development process, therapeutic areas, Good Clinical Practices, and any applicable local regulatory requirements.

 
Requirements:


MD
Fluent official language of the country
English, written and spoken, upper intermediate
PC user
 
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CEO 

  L-IL - Top Talent Acquisition    Tel Aviv Area   27/2/2009 
Category: Biotechnology, Medical Management  
Education:   Position type: Full Time Employee  Experience:  
Area(s) of expertise desired:  
Description:
General responsibility for companys activities
Develop and plan companys targets, goals, assignments and business plan in order to maximize company's achievements
Capital raising
 
Requirements:
MBA
PHD\ MD - preferably in the field of Gynecology\ Immunology
3+ years of experience in senior management in the field of Biomedical in general and clinical researches and pharma specifically
Business orientation
Proven experience in capital raising
Experience in start-up/ incubators companies
Excellent communication skills
 
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