Clinical Trial Manager
CLINICAL TRIAL MANAGER
12 MONTHS INITIAL CONTRACT
DAY RATE AVAILABLE UPON APPLICATION
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 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 company policies and procedures.
The incumbent will be responsible for all regional study management aspects of a clinical study including but not limited to all of the tasks specified below. For all of 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.
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 (eg contingency plan execution); ongoing 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.
OPERATIONAL STUDY LEAD
The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the global study activities, the incumbent will work with the Regional CTM(s) to ensure correlation of global study activities.
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 (eg 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 (eg contingency planning and implementation); global vendor management; global budgetary management; trial master file management; ongoing management of protocol deviations; ongoing review of study data and data cleaning process.
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
LEADERSHIP AND PEOPLE DEVELOPMENT
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, company's SOPs, GCP and local clinical research guidelines/laws
Is responsible for the development plans for direct line reports.
GLOBAL R&D PERSONNEL
The employee 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.
GENERAL COMPLIANCE AND OTHER ROLES
The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as company's policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order 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 health-related field
- Significant pharmaceutical industry or clinical development/medicine experience
- Previous experience of site monitoring and study management essential
- 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
- 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 analyse data, and
- Demonstrate full competency in Microsoft Office programs.
Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Juice Resource Solutions within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.