Clinical Research

5 days ago

مصر, Egypt AstraZeneca Full time

**Key areas of responsibility**:

- Responsible and accountable for planning, coordinating, overseeing, and conducting local/regional clinical trial
- Contributes to the selection of potential investigators.
- Contributes to National Investigators meetings.
- Develop and implement enrolment strategies, monitoring to adjust for dropouts.
- Develop and monitor study budget and timelines and monitor work to ensure quality.
- Trains, supports and advises Investigators and site staff in study related matters
- Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
- Follow up with the CRO for sites Initiation, monitoring and closure
- Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
- Ensures data query resolution in a timely manner.
- Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
- Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
- Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches or ICH-GCP compliance issues to Local Management
- Prepares for and collaborates with the activities associated with audits and regulatory inspections
- Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements.
- Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation.
- Collaborates with local MSLs as directed by line manager.

**Minimum Criteria**:

- Bachelor degree or above, major in pharmacy or health science related background.
- Good knowledge of international guidelines ICH-GCP.
- 2 to 4 years Pharmaceutical Industry experience Medical research or in Medical or Regulatory functions or other relevant functions
- Excellent command of English (both written and spoken).
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Excellent attention to details.
- Good written and verbal communication skills.
- Good interpersonal skills, a good team player, and computer skills
- Be able to prioritize and manage multiple tasks.
- Good negotiation skills.
- Ability to travel nationally/internationally as required.

**Competencies and Personal Attributes**:

- Previous experience in CRA role.
- French language is an addition.
- Ability to work in an environment of remote collaborators.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

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