Sr. Associate, Clinical Trial Management
The Sr ACTM assists the CTM or OSL in the operational execution of assigned clinical studies. The Snr Clinical Trial Management Associate assists the Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies. Depending on the experience of the incumbent, they may be assigned to manage a small study as a Clinical Trial Manager (CTM).
Main Job Duties and Functions of this role:
The incumbent supports the CTM/OSL in ensuring the assigned clinical study(ies) are run to time and budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
The incumbent assists the CTM/OSL in all aspects of a clinical study(ies) including, but not limited, to the tasks specified below:
Study Concept, Planning and Strategy Phase:
The incumbent is responsible to assist the CTM/OSL and FACT team with 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 assists the CTM/OSL in region-specific 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 assist 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 assists the CTM/OSL in: regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; and ensuring adverse event reporting.
The incumbent assists the CTM/OSL in the following activities: supporting database lock activities; ensuring all regional 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 worker is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
• Science degree preferably in science or health-related field
• Previous experience of working on a clinical study
• Oversight or mentoring of more junior study monitors (direct or indirect) preferred
In addition to the essential skills, the incumbent must have the following:
• 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, and
• Understand clinical study budgets
• Plan, organize, project manage and analyze data,
• Advanced computer skills in Microsoft Office
Qualifications / Experience:
• B.A/B.S. in science or health-related field
• Four (4) years clinical research experience or related experience with a Bachelor’s Degree
• Monitoring experience is preferred
|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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