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2017-42986

2017-42986

Title 
Associate Director of Clinical Operations - Study Start Up
Job Locations 
-
US-PA-Blue Bell
Posted Date 
9/19/2017

More information about this job

Overview

Responsible for clinical operations activities and staff within the unit(s). Mentors and leads the clinical operations IHCRA management team, maintains appropriate resources to achieve maximum staff billability and adheres to quality management practices. Provides leadership in the implementation of PRA’s quality initiatives and business processes, achievement of management goals within the framework of the company mission, policy and philosophy. Implements strategic direction to the Clinical Operations department

Responsibilities

  • Implements direction, strategy and performance standards for multiple job disciplines to assure that project profitability targets are achieved
  • Ensures services provided to clients are compliant with PRA’s policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements
  • Mentors and develops employees to expand employee performance levels and assure retention of high performing PRA employees
  • Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations IHCRA staff
  • Accurately projects resource needs to ensure timely hiring of clinical operations IHCRA staff
  • Adjust resource allocation for project work as appropriate to ensure corporate billability targets are maintained while assuring client/ project objectives are achieved
  • Participates in PRA’s Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
  • Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
  • Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts of the same to budget
  • Participates in client presentations and/ or bid defense meetings, as required

Qualifications

Minimum Qualifications

  • Extensive experience using computerized information systems required; experience with PC-Windows, word processing, and electronic spreadsheets required
  • Substantial clinical trials development experience is required
  • Substantial experience supervising or managing professional staff in a clinical research environment required
  • Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required
  • Read, write, and speak fluent English; fluent in host country language required
  • Minimum 3 years line management experience
  • Undergraduate degree, or its international equivalent, in clinical science or health-related field from an accredited institution, or equivalent work experience required

Preferred

  • Advanced degree, or its international equivalent, preferred
  • International clinical development experience preferred
  • Management experience within the CRO environment is preferred 


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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