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Clinical Study Manager

Location:Tel Aviv, Israel, Middle East
Job Type:Permanent
Posted:29th May 2008
Closing Date:26th Jun 2008
Posted By:Hays Pharma
Details:
Clinical Study Manager

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

- 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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