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Careers

Careers

 

Title: Clinical Project Lead
Location: Cairo, Egypt
Job description:

  • Coordination and control over the feasibility, start-up, clinical and site-management activities related to a specific clinical trial within the Department.
  • Strict control over the compliance of study milestones: start, patients’ enrollment (overall study) and timelines as per the contract obligations
  • Control over budget, issue, task and time management of the project/s under his/her supervision.
  • Communication with sponsors, partnering CROs, physicians, or regulatory authorities.
  • Develop Study Specific plans as PMP, monitoring plan, TMF maintenance plan, communication plan, quality plan, project risk matrix.

Qualifications:

  • Scientific background is mandatory, preferably pharmacist or physician.
  • Minimum of 4 years’ experience in the clinical research field includes monitoring activities, study feasibilities and ability to apply applicable regulatory guidelines.
  • Strong written and verbal communication skills including sufficient fluency in English required
  • Successful track record of managing at least 2 ICTs
  • Effective time management skills with ability to set priorities
  • Willing to travel inside and outside Egypt

Title: Clinical Project Manager-MENA
Location: Cairo, Egypt
Job description:

  • Coordination and control over the feasibility, start-up, clinical and site-management activities related to a specific clinical trial within the Department.
  • Strict control over the compliance of study milestones: start, patients’ enrollment (overall study) and timelines as per the contract obligations.
  • Control over budget, issue, task and time management of the project/s under his/her supervision.
  • Communication with sponsors, partnering CROs, physicians, or regulatory authorities.
  • Initiate selection and approval, ongoing management and dealing with all third parties involved in the study.
  • Identify changes, work with team members to quantify financial / time impact and communicate those changes to appropriate personnel.
  • Assisting HCO & BD in contracting process, when required.
  • Control of submission/ approval process to EC/ RA in close collaboration with the clinical research associates.
  • Organization and performing of study team trainings, meetings and customization of study-specific forms.
  • Execute any activities in compliance with applicable SOPs, instructions and principles.
  • Develop Study Specific plans as PMP, monitoring plan, TMF maintenance plan, communication plan, quality plan, project risk matrix (if applicable).

Qualifications:

  • Scientific background is mandatory, preferably pharmacist or physician.
  • Minimum of 5 years’ experience in the clinical research field includes monitoring activities, study feasibilities and ability to apply applicable regulatory guidelines.
  • Strong written and verbal communication skills including sufficient fluency in English required
  • Successful track record of managing at least 3 different projects
  • Effective time management skills with ability to set priorities
  • Willing to travel inside and outside Egypt

Title: Clinical Data Associate
Location: Cairo, Egypt
The main responsibilities:

  • To manage and/or back all aspects of Data Management on a clinical trial from set-up, through conduct, to database lock, with the goal of attaining data quality adequate for analysis and regulatory submission.
  • Work collaboratively with Clinical Data Coordinator, Clinical Data Manager and Project Management staff to encounter project deliverables and timelines for clinical data attainment, quality checking and reporting.
  • Assist in the planning and application of Clinical Data Management processes. Lead and/or support the trial eCRF design and testing procedures for precise data collection.
  • Prove a general understanding of each assigned protocol, critical tasks and milestones.
  • Guarantee completeness, accuracy and consistency of routine clinical data and data structure.
  • Lead and/or support the design and implementation of clinical data management processes including data entry, data quality checking, data transfer, reporting, archiving.
  • Interact with study site coordinators, investigators and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
  • Apply reports & data tools to track study progress to ensure timeliness and quality expectations are met. Identify, track, and resolve queries.

Qualifications and experience:

  • Degree level (or higher) in a Biomedical Science (or equivalent).
  • Experience in Clinical Data Management or related Clinical Research role is preferred.
  • Excellent verbal and written communication skills.
  • Excellent interpersonal skills.
  • The ability to problem solve and have project leadership skills.
  • Understanding of the Drug Development process.
  • Extensive knowledge of web-based Electronic Data Capture (EDC) systems.
  • An understanding of Post Marketing/PhIV/Medical Affairs/Observational studies advantageous.
  • Work with minimal supervision.

Please forward your CV/resume with the position mentioned in the subject along with a cover email to us at jobs@clinart.net