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2017-43192

2017-43192

Title 
Director of Clinical Operations
Job Locations 
-
US-PA
US-NJ
Posted Date 
9/28/2017

More information about this job

Overview

 

Responsible for all operations activities and staff within their unit(s), by assisting in the planning, implementation and monitoring of all ongoing activities and projects in the unit/units. Mentors and leads the operations management, 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. Provides strategic direction to all departments of the unit(s). Ensures staff development, performance feedback and HR policies are properly implemented. Ensures appropriate profitability for all the projects conducted in the unit(s)

Responsibilities

  • Accountabilities (Responsibilities)
  • 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 o 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
  • Sets overall direction, strategy and performance standards for multiple job disciplines to assure that project profitability targets are achieved
  • Schedules and reviews project tasks to ensure high quality product is delivered on time and within the budget o Ensures services provided to clients are compliant with PRA’s policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements o Manages operational budget for the unit(s) 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 staff
  • Accurately projects resource needs to ensure timely hiring of clinical operations staff o Adjust resource allocation for project work as appropriate to ensure corporate billability targets are maintained while assuring client/ project objectives are achieved Establishes processes and 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 May function as legal representative for PRA in selected countries as appropriate

Qualifications

 

  • General Management previous experience or training required
  • Extensive experience using computerized information systems required
  • Substantial clinical trials development experience required
  • Thorough knowledge of ICH and local regulatory regulations regarding drug research and development required
  • Thorough knowledge of local legal framework regarding employment required
  • Thorough knowledge of business administration principles
  • Read, write and speak fluent English; fluent in host country language



  • BS degree or its international equivalent in clinical science or health-related field from an accredited institution, or equivalent work experience required



  • Graduate degree in Life Sciences or MBA, or its international equivalent, 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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