Clinical Operations Leader Otro

  • Parexel Inc.
  • Buenos Aires
  • 13-09-2016
  • Otros
The Clinical Operations Leader is responsible for coordinating the functional
team members and their activities across all geographies, liaising with
project leadership and the sponsor to ensure that the
Global Research Operations deliverables (timeline, quality, productivity) are
met. The Clinical Operations Leader has overall accountability for the
execution of the clinical operations strategy on the project.
May act as Project Leader for projects involving a small number of services,
where no Project Leader is assigned. Tasks assigned as responsibility include
all aspects of the GRO discipline.
Client Liaison
• Effectively communicate with internal and external customers as well as
third party vendors
• Prioritize effectively and respond to urgent requests within team or from
Project Initiation & Planning
• Manage study start-up activities, in small size studies
• Provide input to project tools, PL project plan, Central File Maintenance
• Provide input to the format and content for sponsor reports
• Provide input to and oversight of site selection strategy plan
• Develop site selection and monitoring plans for the team
• Review and provide input into patient recruitment plan and retention plan
• Ensure all team members have access to tools and documents
• Establish efficient / effective working relationships with other functional
Leaders and coordinators across geographies and projects within a given
• Develop study plans, tools and forms.
• Evaluate and identify resourcing needs and continuously monitor over life
cycle of project
• Address identified and escalated site issues and drive to closure
• Early recognize areas of potential problems and provide input to contingency
• Monitor study timelines, patient recruitment, retention and data cleaning to
ensure successful outcome of the project
• Oversee maintenance and quality check of Central Files
• Participate in client, investigator and team meetings
• Maintain a working knowledge and ensure compliance with applicable ICH-GCP
Guidelines, local regulatory requirements and PAREXEL WSOPs, SOPs, Operational
Guidelines, Work Instructions and study specific procedure
• Complete routine administrative tasks in a timely manner ( timesheets,
metrics, office and travel expense claims)
o ability to take initiative and work independently
o excellent interpersonal, oral and written communication skills
o ability to gain trust and confidence with a client as well as within PAREXEL
o excellent presentation skills
o ability to travel as required
o knowledge of SOPs/guidelines, ICH-GCP and other applicable local and
international regulations
o proficient computer and internet skills including knowledge of MS-Office
products such as Excel, Word
• Degree in a life science, nursing qualification or relevant
experienceQualifications Substantial experience in clinical research including
relevant experience as a team Leader in Clinical functions or proven
experience in coordinating clinical trials. Relevant Work experience in
clinical research
• Experience in Coordination of Clinical Trials – Preferably relevant working
experience as an Associate Clinical Operations Leader or proven experience in
a similar role
• Individuals should have a strong understanding of the cross functional

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