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Careers

Careers

 

Title: Manager, Medical Writing
Location: Cairo, Egypt

Medical Writing Manager is a member of the Biometrics & Medical Writing department located in Egypt. The role collaborates with different team members to plan and prepare all types of clinical trial deliverables (i.e. protocols, Analysis Plan, clinical study reports (CSRs), and manuscript) that are accurate, compliant, and submission ready.

The main responsibilities:

  • Write, edit, and format study documentations (i.e. protocols, CSRs) by organizing, analyzing, and interpreting scientific, clinical, and statistical data. Work closely with study teams to ensure that documents are scientifically accurate, internally consistent, and meet intended purpose. Prepare documents in accordance with internal standards and external regulatory guidelines.
  • Develop and maintain document timelines in line with business objectives. Manage writing activities to complete documents within agreed-upon timelines. Identify, communicate, and resolve issues impacting document timelines.
  • Drive document preparation process within qualified network, maintain coordination between all stakeholders and client.
  • Support implementation of reviewer guidelines, process initiatives, and technologic innovations to improve document development process. Suggest changes to document processes or templates to improve quality and/or efficiency. Participate in process initiatives.

Qualifications and experience:

  • At minimum Bachelor’s degree or equivalent in medical-related field or life science required. Post-graduate degree preferred.
  • BS/BA +6 years, MS/MA +4 years, PhD +2 years of medical writing experience is preferred.
  • Solid understanding of the drug development process. Solid knowledge of relevant regulatory guidelines as well as medical and statistical concepts.
  • Medical writing experience in protocols is preferred.
  • Ability to work independently. Ability to work well under pressure and adapt to change as needed.
  • Excellent project management skills to organize work and handle multiple projects at the same time. Ability to guide teams during document development.
  • Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
  • Ability to apply relevant knowledge and experience to solve complex problems, using flexibility and persistence as appropriate.

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.

Title: Clinical Research Associate
Location: Egypt
Qualifications:

  • Scientific background is mandatory, preferably pharmacist or physician.
  • 1-2 years of experience in the clinical research field includes monitoring activities and ability to apply applicable regulatory guidelines.
  • Strong written and verbal communication skills including sufficient fluency in English is required.
  • Effective time management skills with ability to manage competing tasks.
  • Willing to travel inside and outside Egypt.

Title: Clinical Research Associate
Location: Jordan
Qualifications:

  • Scientific background is a must.
  • 1-2 years of experience in the clinical research field includes monitoring activities.
  • Strong written and verbal communication skills including sufficient fluency in English is required.
  • Effective time management skills with ability to manage competing tasks.
  • Willing to travel inside and outside Jordan.

Title: Clinical Research Associate (Saudi Nationals Only)
Location: Saudi Arabia
Qualifications:

  • Scientific background is a must.
  • 1-2 years of experience in the clinical research field.
  • Strong written and verbal communication skills including sufficient fluency in English is required.
  • Effective time management skills with ability to manage competing tasks.
  • Willing to travel inside and outside Saudi Arabia.

Title: Clinical Research Associate
Location: Lebanon
Qualifications:

  • Scientific background is a must.
  • 1-2 years of experience in the clinical research field includes monitoring activities.
  • Strong written and verbal communication skills including sufficient fluency in English is required and preferably French.
  • Effective time management skills with ability to manage competing tasks.
  • Willing to travel inside and outside Lebanon.

Title: Clinical Research Associate
Location: Tunisia
Qualifications:

  • Scientific background is mandatory, preferably pharmacist or physician.
  • 1-2 years of experience in the clinical research field includes monitoring activities and ability to apply applicable regulatory guidelines.
  • Strong written and verbal communication skills including sufficient fluency in French & English are required.\Effective time management skills with ability to manage competing tasks.
  • Willing to travel inside and outside Tunisia.

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

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