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This position will support the development department with regard to the management of clinical studies. The role of a Clinical Study Manger includes the support of the processes of supplier selection and management.
The Clinical Study Manager is responsible and accountable for a particular study from the point in time where the Study Protocol Synopsis is available until the Data base lock and until the Trial Master File (TMF) is archived.
The role is established in order to oversee and manage all activities related to the clinical study, including:
- Overall management of study
- Plan and prepare study
- Conduct study
- Close out study
The Clinical Study Manager leads the study team for a particular study.
Roles & Responsibilities
The Clinical Study Manager's general responsibilities include:
- Lead and guide the Study Team
- Keep close contact to study-related functions
- Support external supplier selection and management of supplier during the study
- Track and control the study and keep the study within the given timelines and budget
- Ensure quality of all steps in preparation, conduct and closure phase of the study by following both national and international laws and guidelines (e.g. ICH/GCP) and GRT SOPs
More specifically, the Clinical Study Manager will:
- Compile and review documents necessary for FDA submission
- Compile and review documents necessary for IRB submission
- Compile and review answers to questions raised by FDA or IRBs
- Select local monitors and sites to be co-monitored
- Develop a co-monitoring plan
- Review and comment co-monitoring report
- Coordinate and/or communicate information to other study related functions
- Define criteria for evaluation of supplier proposal
- Confirm and coordinate outsourcing with the study team and the CRO Manager
- Budget tracking functions
- Maintain methodologies, tools and templates on a regular basis; e.g. Study Plan and Study Status Template
- Other responsibilities as assigned.
Job Requirements
Education:
- Bachelor degree or above preferable in a Life Science or Nursing/Medical
- Managerial expertise, especially in managing studies
- Good clinical operational knowledge (minimum 3 years of pharmaceutical industry clinical operations experience and hands on monitoring experience)
Industry-specific knowledge:
- Experience working for an international pharmaceutical company highly desirable
- Proven project management skills (including planning and tracking)
- Strong implementation skills
- Solid understanding of budgeting and financial tracking
- Knowledge of clinical data management, statistical processes, report writing, regulatory and drug safety requirements
Personal skills & abilities:
- Team building and leadership skills
- Ability to coach and teach team members
- Strong communication skills
- Ability to interact and network effectively
- International/ intercultural working experience
- Delivery focused
- Problem identification and issue resolution skills
- Ability to motivate Study Team to deliver
- Ability to provide objective feedback
- Attention to detail and follow-up