Clinical Operations Line Manager - FSP

Job Title: Clinical Operations Line Manager - FSP
Contract Type: Permanent
Location: Sydney, Australia
Salary: $135000 - $150000 per annum
Start Date: 2019-02-05
Reference: BH-98488-2
Contact Name: Christopher Parkinson
Contact Email:
Job Published: February 05, 2019 04:33

Job Description

As Clinical Line Manager for an exciting FSP model, you will manage and support the delivery of day-to-day site activities. Collaborate with customers and stakeholders to develop and deliver patient and site operations plans; contributes to site performance metrics; continually improving the quality and consistency processes used at clinical sites; and prepares, distributes, and files client deliverables and SOP or scope of work documentation.

This role  is based in Sydney. 

Responsibilities include:

  • Manage staff in accordance with organization's policies and applicable regulations.
  • Participate in the selection and on boarding process for new clinical staff by conducting candidate review and participating in the interviewing process.
  • Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
  • Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
  • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
  • Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
  • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
  • May fill in as a CRA or CRS for a defined project or to assist with milestone achievement on a temporary basis.

Skills and experience required:

  • Bachelor's degree in a health care or other scientific discipline or educational equivalent
  • 7 yrs of clinical trials experience including 3 years' experience in a leadership capacity managing CTA's and CRA's or equivalent combination of education, training and experience
  • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Strong leadership skills
  • Excellent organizational and problem solving skills
  • Effective time management skills and ability to manage competing priorities
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients