Clinical Research

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.
* Follow up with CRO on the submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
* 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