Clinical Trial Manager

Employer
3D Search, Inc.
Location
Mahwah, NJ
Posted
May 18, 2017
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe


Job Description

Summary

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.

Exciting Opportunity

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.

Experience

Bachelors Degree with 3+ years in a Clinical Trial Management position

Respiratory experience is preferred, but not required



Mahwah, NJ

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Wed, 17 May 2017 04:43:23 PDT

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