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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.
· Provide input to and oversight of site selection strategy plan.
· Develop site selection and monitoring plans for the team.
· Effectively communicate with internal and external customers as well as third party
· Prioritize effectively and respond to urgent requests within team or from sponsor.
· Establish efficient, effective working relationships with other functional Leaders and
coordinators across geographies and projects within a given program.
· Provide leadership and direction to project team members.
· Provide productivity targets to project team members.
· Address identified and escalated site issues and drive to closure.
· Early recognize areas of potential problems and provide input to contingency plans.
· Monitor study timelines, patient recruitment, retention and data cleaning to ensure
successful outcome of the project.
· Identify changes in scope and liaise with Project Leader.
· May be required to conduct site visits as per client or project demands.
· Prepare, participate in and follow up on audits / inspections.
· Participate in all required applicable trainings.
· Together with Project Leader ensure all administrative closeout procedures are
completed, according to Project Close-out Checklist.
· Together with Project Leader ensure project is archived and all documentation
returned to the client as specified by the contract.
· 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 activities.
PAREXEL International is a growing, fast-paced, global Clinical Research Organization
(CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company.
If you are interested in the position, please submit your CV directly to: Filip.Klacz@parexel.com