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Regional Clinical Project Lead (CPL)

Full Time
Ray - 
Cairo, EgyptPosted 3 years ago
65Applicants for3 open positions
  • 2Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

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Job Description

  • Provides clinical research expertise in the development and conduct of day-to-day activities through all phases of a clinical trial (start up, recruitment and enrollment, data management, close out and archiving in the middle east UAE, Saudi Arabia, Kuwait ,Qatar,  Lebanon, Jordan.
  • Assists in planning, managing, implementation and reporting of clinical trials. Oversees preparation and implementation of project specific training programs and training materials for internal staff .
  • Evaluate the resources needed vs resources available for the clinical trials running and planned. Provide strategic input aimed at ensuring continuous improvement in the way we operate and implement Standard Clinical Operating Procedures relevant to the purpose of the position. Interact with local Medical, Marketing and other key players to allocate trials (both regional and local as appropriate. Report on status of actual vs planned recruitment from all centers participating in trials in the Country.
  • Manage interdisciplinary clinical research projects, as Project Manager, leading the clinical team to ensure on-time, on- budget performance.
  • Supervise, train, and mentor Clinical Research staff.
  • Approve investigator study budgets and contracts.
  • Review and approve regulatory and administrative documents from investigator sites.
  • Supervise protocol development, operational manual development and the assimilation of all resources and services necessary to perform contracted services..
  • Review and approve Case Report Forms (CRFs).
  • Plan, coordinates, and present at Investigators, Meetings.
  • Participate in proposal meetings with potential clients.
  • Review Serious Adverse Event (SAE) reports.
  • Review and approve monthly client invoices.
  • Prepare project management reports for clients, project personnel, and PharmaNet management.
  • Review and approve monitoring trip reports.
  • Review Tables and Listings generated from study data.
  • Author Clinical Study Reports.
  • Train CRAs on monitoring, internal procedures, and query resolution.
  • Mentor Senior CRAs on project management procedures and policies.
  • Provide direct communication link between Company and Sponsor to assure that the needs of the project are met, reporting all areas of concern to assure timely and appropriate resolution of client issues.
  • Assure all aspects of clinical trial operation and reporting are performed in accordance with client requirements, applicable corporate SOPS, ICH and GCP guidelines.

 

Job Requirements

  • Lead, motivate, and set objectives managing performance to assure completion of goals and development of staff. Ensure that prevailing legislation, GCP, Ethical Committee, and standard operating procedures requirements are fulfilled and monitor adherence to and compliance with standard operating procedures. 
  • Excellent knowledge of Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Excellent knowledge of the national and regional regulations for conducting clinical trials.
  • Proven ability to work through others to deliver results to the appropriate quality and timeline metrics.
  • Proven ability to understand customer needs.
  • Effective mentoring and training skills.
  • Ability to balance operational and strategic priorities.
  • Strong communication and interpersonal skills, including good command of English language, French is a plus.
  • Excellent presentation skills.
  • Demonstrated proficiency in using systems and technology to achieve work objectives.
  • Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making.
  • Proficient with all computer applications such as Word, Excel, Outlook and PowerPoint.
  • More than 6 years of proven experience in the clinical research field and study management.
  • A minimum of 2-3 years of experience in a similar managerial position.
  • Occasional travel requirements.
  • Bachelor degree of medical background (Physician, Pharmacist).

 

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