Clinical Trial Manager
The Clinical Trial Manager (CTM) is responsible for the operational execution of assigned clinical study(ies). Depending on the experience of the incumbent, they may be assigned as the Operations Study Lead (OSL) of a small study.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required.
As a result, the percentage of time spent across key duties listed below for which the employee is responsible for or assisting with will vary.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
The incumbent ensures the assigned clinical study(ies) is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
The incumbent will be responsible for all regional study management aspects of a clinical study including but not limited to all the tasks specified below. For all the regional study activities in a global study, the incumbent will work with the OSL to ensure regional activities support the timelines of the global study. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Protocol Review Team, Clinical Trial Team, Case Report Form Review Team, Clinical Study Report Review Team, and the Medical Safety Monitoring Plan Review Team.
Study Concept, Planning and Strategy Phase
The incumbent is responsible to work with the FACT team for regional study feasibility, 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: region-specific document development including the informed consent forms; regional investigator meetings;/presentation of materials; the development of regional enrolment initiatives; input any regional specifics to the global study budget via the OSL; planning regional clinical study supplies. They are responsible for obtaining required translations and collecting non-essential documents from site, and ensuring sites are trained in collaboration with the site monitor.
Study Management/Conduct Phase
The incumbent is responsible for: regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrolment management (e.g. contingency plan execution); periodic review of protocol deviations; regional vendor management; and ensuring compliance of adverse event reporting.
The incumbent is responsible for: supporting database lock activities; ensuring all regional documents are filed in the TMF sections appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
• Science Degree or applicable field
• Significant pharmaceutical industry or clinical development/medicine experience
• Previous experience of site monitoring and study management preferred
Employee must have a good understanding of the following:
• 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
Ability to travel up to 25% of time
Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.
|Will this position require driving? || || |
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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