Manager, Clinical Trial
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world's fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Position Description
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.
Main Areas of Responsibilities
• 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.
• Close-Out Phase
• 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.
• The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all the tasks specified below. For all the global study activities, the incumbent will work with the regional CTM(s) to ensure correlation of global study activities. 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. If a Corrective and Preventive Action is put in place, the incumbent may be asked to serve as the CAPA Lead.
• Study concept, planning and strategy phase
• The incumbent is responsible for: ensuring global study feasibility in collaboration with the FACT team and regional CTMs (if global study) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study specific documents and timelines as required.
• Study Initiation Phase
• The incumbent is responsible for: global essential document development (e.g. study level consent forms, advertising materials), and study deviation specifications; assessing global vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of global enrollment initiatives and budgetary planning; planning clinical study supplies; review and approval of data management plan.
• Study Management/Conduct Phase
• The incumbent is responsible for: global IMP supply management; study enrollment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file management; periodic review of protocol deviations;
• Close-Out Phase
• The incumbent will be responsible for: review of CSR shells; review of CSR and assembly of appendices; database lock activities; finalization of the study protocol deviations repository; ensuring that the study close out activities are completed; 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.
• Participates in all relevant and required SOP and in-house training seminars.
• Is responsible for ensuring that all direct reports' training is current for therapeutic area, Allergan SOPs, GCP and local clinical research guidelines/laws
• Is responsible for the development plans for direct line reports.
Requirements:
Requirements
The following listed requirements need to be met at a minimum level to be considered for the job:
• Significant pharmaceutical industry or clinical development/medicine experience
• 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
• General therapeutic area education and training
• Ability to travel up to 25% of time
Preferred Skills/Qualifications
• 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 budget
• Plan, organize, project manage and analyze data
• Previous experience of site monitoring and study management preferred
• Demonstrate full competency in Microsoft Office programs
Education
• Science Degree (or health-related field) or higher degree
*LI-GA1
