Clinical Trial Management Associate
Orange County Metro Area, CA
- The incumbent is responsible for performing tasks as assigned by their manager which includes, but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across departments, supporting the monitoring team and study
sites with relevant study information, and supporting clinical operations.
The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures.
The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Case Report Form Review Team and Clinical Trial Team.
The incumbent is responsible for all aspects of the clinical study including, but not limited, to the tasks specified below.
Study Concept, Planning and Strategy Phase:
The incumbent is responsible to support and work with the FACT team to conduct study feasibility. They are responsible for the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.
Study Initiation Phase:
The incumbent is responsible for supporting document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies.
They are overall responsible in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.
Study Management/Conduct Phase:
The incumbent is overall responsible for supporting the following: study financial management; database lock activities; study drug management; trial master file management; study enrollment management (e.g. contingency plan execution); periodic review of protocol deviations; vendor management; and ensuring adverse event reporting.
The incumbent is overall responsible for supporting the following activities: database lock activities; ensuring all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
The incumbent is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
Other activities, special projects and assignments may be given as required.
Science degree preferably in science or health-related field
Previous experience working on a clinical study
In addition to the essential skills, the incumbent must have the ability to:
Handle and prioritize multiple tasks simultaneously,
Work effectively in a team/matrix environment,
Understand technical, scientific and medical information,
Handle conflict management and resolution,
Understand clinical study budgets,
Plan, organise, project manage and analyse data, and
Demonstrate full competency in Microsoft Office programs.
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Knowledge of concepts of clinical research and drug development, and
General therapeutic area education and training