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Director / Sr. Director of Clin Ops

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Location
MA
Salary
$185,000 - $240,000
Job Type
Direct Hire
Date
Apr 27, 2016
Job ID
2341584
Description:
Directs all aspects of the Clinical Operations Department including oversight of operations and development of procedure and standards for clinical trials monitoring and trial management. Responsible for planning and scheduling workload and staff levels, and ensuring adequate levels of training are carried out to meet performance and quality standards in handling of multi-site and multi-project work.
Responsible for strategic planning, implementation and management of the Clinical operations function. Develop and implement resource allocation plans for the group.
Accountabilities/Responsibilities:
This position will lead the Clinical Operations group, directs clinical trial execution operations for all clinical trials
  • Meets with Clincal staff and cross functional teams to identify and address resourcing and project issues.
  • Provides guidance to Clinical Program Managers in a wide range of trial management practices.
  • Manage all functional areas of the Clinical operations group; data management, safety, medical monitoring, vendor selection and management, central files medical writing.
  • Leads all vendor selection and qualification efforts to support clinical trials.
  • Oversees the development of the clinical quality management components, including S0Psand Quality Assurance activities related to the clinical trials vendors and sites.
  • Ensures development and implementation of timelines and ensures timely completion of projects within budget.
  • Directs development, monitors and adheres to both project specific and Clinical Operations departmental budgets. Manages clinical budgeting and contracts and consults with program leaders.
  • Identifies training opportunities within Clinical Research and recommends courses to ensure qualified, trained Clinical Research personnel. Ensures coordination of clinical training.
  • Provides technical and operational mentoring and practical guidance to a team of Clinical Program Managers/Senior Clinical Scientists/Clinical Scientists.
  • Advises on clinical coordination of start-up activities.
  • Oversees and participates in development and review of SOPs and other departmental policies.
  • Manage database operations, including the investigation, assessment, and hiring of contractors, and development of timelines. Oversee the technical design, creation and development of the clinical trial management databases.
 
Qualifications:
 
BA/BS/M or RN and 8-10 years experience in the health care field with a minimum of 10 years direct Clinical Operations experience. Prior drug development experience essential. In depth and working knowledge of GCPs, FDA regulations and the Drug  Development process is essential. Prior clinical monitoring management experience required. Prior project management experience preferred. Excellent communication, organizational, interpersonal and leadership skills
Broad knowledge of pharmaceutical clinical development required. Proven ability to effectively apply technical principles, theories and concepts to clinical drug development; proven ability to contribute to strategic project planning and timeline development. Proven ability to manage a group effectively. Ability to advise, direct and manage team to resolve problems and to achieve goals on schedule. Able to interpret and evaluate data. Experience in auditing and  editing written summaries of data for reports, presentations or publications.  Strong leadership skills.