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Job Search Results: Jobs 1 - 10 of 36  View Titles Only  Page 1 of 4
 
Title   Company Name     Location   Date  
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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Sr. Principal Biostatisticians 

  Makro Technologies    All   28/11/2006 
Category: Biotechnology, Clinical Research, Medical Equipment  
Education: Masters   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Biostatistics, Clinical Data Management, Clinical Research, Regulatory Affairs  
Description:
Full Requirement : Responsible for all statistical tasks on the assigned clincial trials, e.g. clinical trial design/planning, analysis plan, reporting activities including programming tasks, exploratory analyses and additional analyses to support publications. Write statitical methodology section of protocol, statistical section of clinical trial report and review clinical trial report. Oversee CRO deliverables for trials contracted out. Minimum requirements MS in Statistics with at least 6 years of pharmaceutical experience or PhD in Statistics with at least 2 years of experience for Sr. Prinicipal Biostatistician. Solid, hands-on experience as a lead statistician in protocol development, analyses, study reports, for Phase II-III clinical trials. Strong statistical skills and good knowledge of SAS. Good knowledge of drug development process. Project management skills. Experience in supporting clincical development plan and/or NDA submissions. Experience participating in internation teams. Very good oral and written communication and negotiation skills.  
Requirements:
Education:
Phd/MS in Statistics
Required years of experience Five - Seven Years in Pharma or Biotech industry  
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CLINICAL TEAM LEAD 

  Hays Pharma    All   30/9/2008 
Category: Clinical Research  
Education:   Position type: Full Time Employee  Experience: 3 years 
Area(s) of expertise desired: Clinical Research  
Description:
An excellent opportunity has arisen to join this global Contract Research Organisation as a Clinical Team Lead.

The purpose of the role is to manage the execution of the clinical component of study protocols in accordance with the scope of work and contracted timelines.

May act as a CTL for large scale projects under the supervision of a more senior CU, or Line Manager. May also serve as a Sr Clinical Research Associate (Sr CRA) within the project or other projects as needed.

ALL APPLICATIONS TO BE MADE IN ENGLISH PLEASE.  
Requirements:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines

In depth therapeutic and protocol knowledge as provided in company training

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

Strong written and verbal communication skills including good command of English language

Excellent organizational and problem-solving skills

Effective time management skills

Strong presentation skills

Effective mentoring and training skills

Ability to lead and motivate a culturally-mixed clinical team

Ability to manage competing priorities


MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelors degree in a health care or other scientific discipline or educational equivalent; 3 years clinical monitoring and one year in a project leadership role or equivalent combination of education, training and experience

 
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CLINICAL RESEARCH ASSOCIATES (all levels) 

  Hays Pharma    All   30/9/2008 
Category: Clinical Research  
Education:   Position type: Full Time Employee  Experience: 1 year 
Area(s) of expertise desired:  
Description:
Our client, a highly reputable leading global Contract Research Organisation, is looking for Clinical Research Associates to join the team. The purpose of the role is to identify, select, initiate and close-out appropriate investigational sites for clinical studies and to monitor these sites ensuring that the studies are performed in accordance with the SOPs, applicable regulations and ICH-GCP guidelines.

ALL APPLICATIONS TO BE MADE IN ENGLISH PLEASE.

 
Requirements:
Education and qualifications

Medical/science background and 1 year previous clinical research experience;

Ability and willingness to travel at least 50% of the time;

Ability to review and evaluate clinical data;

Computer literacy desirable;

Good use of English;

Good oral and written communication skills.


 
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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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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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Home Phone Agent - patients screening for clinical trials 

  nRollmed    All, Tel Aviv   1/8/2018 
Category: Clinical Research, Sales/Marketing  
Education:   Position type: Part Time  Experience:  
Area(s) of expertise desired:  
Description:
nRollmed agency - online patient recruitment & retention for clinical trials, is seeking for professionals to conduct phone pre-screening of potential patients considering participation in clinical trials.

This job is suitable for those looking for a partial position and wishing to work from home.
 
Requirements:
Requirements:
* English as a mother tongue
* Working on US time zone
* ability to build trust and confidence over the phone
* active listening and empathy
* administrative capabilities
* medical related education / experience - an advantage.
* experience in clinical trials - an advantage
 
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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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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 Data Manager 

  Makro Technologies    All   28/11/2006 
Category: Biotechnology, Clinical Research, data management  
Education: Bachelors   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research  
Description:
Responsibilities
In this role, you will handle detailed Data Management issues for all Phases of clinical trials (Phase 1-4) including oversight of CRO data Management activities.

Additionally, you will participate in study planning and initiation data activities (e.g., CRF design, database design, annotated CRF, and edit check/Data Management Plan development in conjunction with the clinical study team ensuring application of Cubist data standards.

You will also ensure the accuracy, completeness, and consistency of clinical databases, carry out safety and microbiology data loading/transfer procedures, prepare materials for NDA vendors, actively participate in the NDA and e-submission process, prepare ad hoc data listings and review analysis tables, listings, and figures for consistency and accuracy.

Moreover, you will be expected to work closely with lead study and Project managers to develop timelines and review budgets and contracts to ensure departmental and corporate clinical trial data management objectives are met, as well as develop and SOPs, departmental guidelines, data standards and other activities to support DM and biostatistics as needed.
 
Requirements:
Qualifications

Top candidates for this position will have a minimum of a BS/BA in a scientific discipline or equivalent, a minimum of 5 years experience as a Data Manager in a CRO or Pharmaceutical/Biologics/Medical Device company, and experience as a lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials).

Demonstrated experience with a data management system (e.g., Clintrial or Oracle Clinical), ability to work interdependently with minimal supervision, and excellent written and oral communication skills are required.

Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries is necessary;

Proficiency in basic SAS and/or JMP (preferred) or a demonstrated ability to learn basic programming skills is fundamental;

Familiarity with ICH GCP as well as general knowledge of industry practices
and standards (CDISC, SDTM) are essential.
 
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