Clinical Site Manager

1 week ago

Australia beBeeClinical Full time $80,000 - $150,000
Senior Clinical Research Associate Role

Maintenance of study integrity is paramount. Direct site contact and oversight are key to ensuring adherence to protocols.

  • Direct site contact involves assessing overall implementation integrity and resolving issues promptly.
  • Building strong relationships with investigators and site staff fosters collaboration and effective communication.
  • Access to relevant study systems and compliance with training requirements ensure seamless site operations.
  • Evaluating on-site staff assignments ensures accuracy and necessitates corrective actions when necessary.
  • Resolving site issues, including documentation and communication deficiencies, is crucial.
  • Following up on previous visit issues and responding to site-related questions demonstrates proactive approach.
  • Applying working knowledge identifies data quality and integrity issues, prompting follow-up action.
  • Participating in investigator and external meetings, audits, and inspections maintains regulatory compliance.
  • Collecting, reviewing, and approving site documentation, including regulatory documents, ensures accuracy and completeness.
  • Collaborative evaluation of site recruitment plans optimizes improvement strategies.
  • Conducting on-site visits, including qualification and initiation visits, resolves site issues independently.
  • Remote visits and contacts facilitate flexible site management.
  • Generating visit reports and evaluating overall site compliance ensures high-quality delivery.
  • Managing test articles, supplies, and payments promotes efficient site operations.
Key Responsibilities

Deliver exceptional site management services that foster a culture of excellence.

  • Proactively address site issues, prioritize tasks, and achieve project timelines.
  • Ensure timely and accurate completion of project goals, update trial management systems, and manage site data entry.
  • Build and maintain positive relationships with site staff, investigators, and other stakeholders.
  • Monitor and maintain compliance with ICH-GCP, local regulations, and Parexel SOPs.
  • Delegate administrative tasks to the Administrative Support Team and provide feedback on their performance.
  • Develop expertise in site management and become a subject matter expert.
  • Work independently with minimal oversight, complete additional tasks efficiently, and adapt to changing priorities.
Requirements

Highly skilled individuals are sought for this role, possessing excellent problem-solving skills, client-focused approach, and strong analytical skills.

  • Excellent interpersonal, verbal, and written communication skills are essential for success.
  • Strong computer skills, including CTMS, EDMS, and MS Office products, enable efficient task completion.
  • Able to work in a matrix environment, value teamwork, and prioritize multiple tasks effectively.
  • Ability to successfully work in a virtual team environment and accommodate extensive travel time requirements.
  • Detail-oriented and able to hold a driver's license where required.
Knowledge and Experience

Site Management experience or equivalent clinical research experience is desired, with a strong understanding of clinical trials methodology and terminology.

  • Education to degree level (biological science, pharmacy, or other health-related discipline) or equivalent nursing qualification or experience is preferred.

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