Vacancies

Requirements

Minimum 3 years in PV area/Drug Safety/Regulatory

Knowledge of EU Pharmacovigilance legislation and applicable local requirements

Willingness to liaise with clients for various levels of PV consultancy

Ending message

Interested candidates can send their CVs to [email protected].

Location

United Arab Emirates

Principal Duties and Responsibilities

  • Maintains paper and non-drug supplies:
    • Ensures the ordering, tracking and distribution of CRFs, IBs, study materials to investigators and in the local area office, as agreed with CRA.
    • Ensures appropriate receipts are maintained at the local area office and at the investigator site.
    • Ensures an accurate filing of documentation and ensuring an audit trail for essential documents and supply tracking documents.
  • Maintains center specific files:
    • Is responsible for the receipt, filing and onward transmission to TMF and SMF of essential documents and correspondence.
    • Maintains local center / country specific files, as appropriate.
  • Tracking and coordination:
    • Serves as the central coordinator of all communications/correspondence regarding essential document aspects of the project.
    • Distributes correspondence to project team members as appropriate.
    • Attends clinical team meetings and prepare minutes as appropriate.
  • Pre-trial activities:
    • Cooperates with the CRA in establishing requirements of each IEC/IRB.
    • Prepares and follows up on all documents for study initiation.
    • Prepares documents for submission to regulatory authorities.
  • Other duties as needed or required.

Supervision Received

The candidate should report to the COM of Phoenix Clinical Research, with regular/close supervision.

Requirements

• Holds a Master’s degree in Life Science or equivalent at least.
• Minimum 2 years of clinical research experience.
• Good knowledge of SOPs, ICH-GCP and local laws and regulations.
• Good time management.
• Deals with confidential information and/or issues using discretion and judgment.

Other Qualifications & Skills

  • Ability to work across teams (often remotely) as well as independently.
  • Organizational skills.

Ending message

Interested candidates can send their CVs to [email protected].

Location

Saudi Arabia

Principal Duties and Responsibilities

  • Maintains paper and non-drug supplies:
    • Ensures the ordering, tracking and distribution of CRFs, IBs, study materials to investigators and in the local area office, as agreed with CRA.
    • Ensures appropriate receipts are maintained at the local area office and at the investigator site.
    • Ensures an accurate filing of documentation and ensuring an audit trail for essential documents and supply tracking documents.
  • Maintains center specific files:
    • Is responsible for the receipt, filing and onward transmission to TMF and SMF of essential documents and correspondence.
    • Maintains local center / country specific files, as appropriate.
  • Tracking and coordination:
    • Serves as the central coordinator of all communications/correspondence regarding essential document aspects of the project.
    • Distributes correspondence to project team members as appropriate.
    • Attends clinical team meetings and prepare minutes as appropriate.
  • Pre-trial activities:
    • Cooperates with the CRA in establishing requirements of each IEC/IRB.
    • Prepares and follows up on all documents for study initiation.
    • Prepares documents for submission to regulatory authorities.
  • Other duties as needed or required.

Supervision Received

The candidate should report to the COM of Phoenix Clinical Research, with regular/close supervision.

Requirements

• Holds a Master’s degree in Life Science or equivalent at least.
• Minimum 2 years of clinical research experience.
• Good knowledge of SOPs, ICH-GCP and local laws and regulations.
• Good time management.
• Deals with confidential information and/or issues using discretion and judgment.

Other Qualifications & Skills

  • Ability to work across teams (often remotely) as well as independently.
  • Organizational skills.

Ending message

Interested candidates can send their CVs to [email protected].

Location

Egypt

Principal Duties and Responsibilities

  • Maintains paper and non-drug supplies
  • Maintains center specific files
  • Tracking and coordination
  • Pre-trial activities
  • Manages Phoenix CR Egypt office
  • Performs administrative activities related to the management of the Egyptian office and Egypt employees
  • Supports CRAs with site monitoring activities
  • Performs regulatory activities
  • Performs feasibility activities
  • Performs business development activities
  • Other duties as needed or required

Supervision Received

The candidate should report to the COM of Phoenix Clinical Research, with regular/close supervision.

Requirements

  • Holds a Bachelor’s degree in Life Science or equivalent at least
  • Fresh graduate to one-year experience
  • Preferably a male
  • Good knowledge of SOPs, ICH-GCP and local laws and regulations
  • Deals with confidential information and/or issues using discretion and judgment
  • Enthusiastic, motivated and able to work independently and communicate with a variety of healthcare professionals at monitoring sites
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Effective time management skills
  • Strong written and verbal communication skills including good command of English

Other Qualifications & Skills

  • Strong leadership skills
  • Organizational and problem solving skills

Ending message

Interested candidates can send their CVs to [email protected].

Location

Lebanon

Principal Duties and Responsibilities

  • Maintains knowledge and ensures compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs, project specific procedures and project scope, budget, etc. (e.g. Project and Monitoring Plan)
  • Ensures timely completion of role based and project specific trainings
  • Supports timely selection of qualified investigational sites (with clinical project manager/project team)
  • Builds strong and lasting relationships with site investigators and site teams/staff
  • Schedules, plans, prepares for and then performs site monitoring visits according to the monitoring plan and SOPs to ensure appropriate monitoring activities are completed at each onsite or remote visit (e.g. SDV, site staff training, investigator site file review, compliance checks, drug accountability, observational visits, facility review, etc.).
  • Applies judgment and knowledge to independently resolve sites issues, questions and concerns
  • Provides timely updates to tracking systems/clinical trial management system (CTMS) as needed
  • Collects, compiles and reviews new/updated/amended site regulatory package (SRP) documents in collaboration with Clinical Trial Specialists (CTS)/project team on an ongoing basis
  • Submits to and follows up with site staff on Clinical Site Agreements (CSA) (including budget), and site-specific Informed Consent Forms (ICF)
  • Provides prepared EC package to the Principal Investigator (PI) for submission and follows up to secure approval where required
  • Plans and evaluates patient recruitment, reviews and provides updates to applicable project tracking systems
  • Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and escalation according to protocol/regulatory requirements
  • Responds to site issues, ascertains and recommends appropriate follow-up response to issues including potential deficiencies in documentation, communication, and the need for additional training
  • Evaluates overall compliance and performance of sites and site staff: provides recommendations regarding site-specific actions and uses judgment and experience to assess the ability and motivation of site staff
  • May assist Project Manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.
  • Other duties as needed or required

Supervision Received

The candidate should report to the Line Manager, with regular/close supervision.

Requirements

  • Bachelor’s degree in a science related field or equivalent certification/licensure from an appropriately accredited institution
  • Minimum 3 years of experience as CRA (clinical research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others)
  • Valid Driver’s License where applicable
  • An equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
  • Deals with confidential information and/or issues using discretion and judgment

Other Qualifications & Skills

  • Effective clinical monitoring skills
  • Excellent understanding and demonstrated application to FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
  • Ability to mentor and train other monitors in a positive and effective manner
  • Ability to evaluate medical research data and proficient knowledge of medical terminology
  • Excellent interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Excellent team player with team building skills
  • Ability to work independently as required
  • Ability to utilize problem-solving techniques applicable to constantly changing environment
  • Effective verbal and written communication skills, with the ability to communicate effectively with medical personnel
  • Good command of English language and grammar
  • Flexibility to travel

Ending message

Interested candidates can send their CVs to [email protected].