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Job Search Results: Jobs 1 - 4 of 4  View Titles Only  Page 1 of 1
 
Title   Company Name     Location   Date  
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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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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Clinical Study Manager 

  Hays Pharma    All   18/6/2008 
Category: Life Sciences, Clinical Research  
Education: Bachelors   Position type: Full Time Team Leader  Experience: 8 years 
Area(s) of expertise desired: Clinical Research  
Description:
Our client, a global Clinical Research Organization is seeking an experienced Clinical Study Manager to join their successful team.

Qualifications

Proven track record in study management, who possess well developed communications skills, and who will enjoy working with team. Your expertise as a Study Manager of International trials will ensure that clinical stages of research projects are completed efficiently and in accordance with customer expectations, enabling us to continue our success.

The successful candidate will have a degree, or equivalent, in a scientific or healthcare discipline complemented by solid international study management experience as a Clinical Study Manager for large scale cross-regional or International trials and previous experience as a successful and accomplished Clinical Research Associate

This role involves managing the execution of the clinical component of large, complex study protocols or global projects in accordance with the scope of work, contracted timelines and study budget. This involves the management of clinical study set-up through to the ongoing tracking and review of the study progress and reporting to relevant members of senior management.

Responsibilities

- Collaborate with other functional groups within the company such as data management, pharmacovigilance, and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Provide ongoing training and support to the clinical team, including the mentoring of less experienced Clinical Team Leaders. Establish study tools and training materials. Conduct frequent team meetings and ensure regular communication.
- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
- Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Manager. Develop proactive contingency plans to mitigate clinical risk.
- Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings. Implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
 
Requirements:
Requirements

- In depth knowledge of, and skills in applying, applicable clinical research regulatory requirements
- Bachelor's degree in a health care or other scientific discipline or educational equivalent
- significant experience working on clinical trials including monitoring as well as previous experience in a project leadership role with expanding cross-regional/global focus
 
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Senior CRA 

  Hays Pharma    All   18/6/2008 
Category: Life Sciences  
Education: Bachelors   Position type: Full Time Team Leader  Experience: 3 years 
Area(s) of expertise desired: Clinical Research, Gastroentology  
Description:
As a Senior Clinical Research Associate you would perform trial initiation, close out activities, you would coordinate monitoring activities, manage site activities to ensure clinical data integrity in line with company Regulatory and Ethical guidelines for Good Clinical Practice. You would provide clinical and technical support and would develop CRFs and act as liaison between monitoring and other functions.You would also operate as the focus for communication with Clinical Research Associates and the Sponsor. You would also act as the lead contact of the project team with study site personnel and also act as a mentor for CRAs. As you would report to the project leader and may assume the role of Lead CRA by providing direction to the project team.  
Requirements:
-Experience as a Clinical Research Associate
-Co-ordination skills
-Experienced in conducting allocated tasks
-Maintain up-to-date knowledge of ICH-GCP, EU CT Directive and FDA guidelines
 
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