Clinical Trial Manager
To manage global clinical trials in respiratory indications such as COPD, Asthma, and Allergic Rhinitis. with specific focus on the technical (medical/scientific) input and operational coordination of clinical studies, with external experts, service providers, internal department and project teams.
Want to be part of a newly created clinical operations group? My client is rapidly expanding/hiring, as they have taken on new trials in their novel therapeutic division. You will have a chance to grow alongside the company, as well as make the position your own.
- Manage and direct the efforts of CRAs assigned to project. Manage performance, scheduling and work assignments
- Monitor expenditure of funds relative to budgetary targets for assigned trials on an ongoing basis. Ensure that variances are identified and communicated to the appropriate personnel in a timely manner.
- To independently manage/handle assigned clinical study in-house or via CRO.
- Prepare the study budget in consultation with project management/line manager/business development for the assigned projects.
- Prepare the project/monitoring plan for the study/ies. Track and ensure that project timelines and milestones are being met. Maintain and update all trackers to evaluate the progress of the study.
- Identify and communicate delays the line manager/department head in a timely manner.
- Suggest and facilitate contingency planning and implementation in order to meet timelines.
- Implement the initiation of the study sites, with the appropriate follow up (co-monitoring, reviewing of reports, recruitment tracking) and close out (archiving of files, collecting of IP and trial materials) of study centers on the assigned projects.
- Lead and supervise the CRAs in activities for the clinical studies, delegate tasks commensurate with skill levels while increasing knowledge base.
- Assist in preparation of dossier and/or appropriate documentation for regulatory/ethics committee submission or other appropriate bodies on time as per required format.
- Provide creative solutions for issues impacting study and team members.
- Act as a key operational interface in the management of clinical studies.
- Provide clinical research expertise in support of other departments and line functions.
- Contribute in preparation and implementation of project specific training programs and training materials for internal and external staff.
- Perform other related duties incidental to the work for training and development.
- Develop and implement orientation programs for new team members including the ongoing training, continuing education and professional development programs for others.
- To perform the ongoing assessment for the direct reports and to recommend/facilitate in the conducting the necessary training for the team in the identified gap areas.
Bachelors Degree with 3+ years in a Clinical Trial Management position
Respiratory experience is preferred, but not required
Wed, 17 May 2017 04:43:23 PDT