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.
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;
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 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.
The worker is responsible for completing all required training to execute their job and maintain their training records. They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate.
They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.
The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected to maintain a solid knowledge base for performing assigned tasks.
Other roles may be allocated as appropriate to the incumbent as required to ensure delivery of the clinical studies.
• 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
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, organize, project manage and analyze data, and
• Demonstrate full competency in Microsoft Office programs.
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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