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The Senior 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 Clinical Operations deliverables (timeline, quality, productivity) are met.
The Senior 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. This position is responsible for coordination of clinical team for a small to midsize project(s) and therefore acts as a role model and / or coach for the team.
This position can also be part of a global project management team.
Effectively communicate with internal and external customers as well as third party vendors
Prioritize effectively and respond to urgent requests within team or from sponsor.
Manage study start-up activities
Provide input to project tools, PL project plan, Central File Maintenance Plan
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
Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies within a given program
Develop study plans, tools and forms
Provide leadership and direction to project team members
Evaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle of project
Provide productivity targets to project team members
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
Maintain and assure quality of work generated and escalate and follow up as appropriate
Implement and instigate process improvements within the project
Provide input to the Revenue Recognition forecast
Identify changes in scope and liaise with Project Leader
May be required to conduct site visits as per client or project demands
Participate in client, investigator and team meetings
Prepare, participate in and follow up on audits / inspections
Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
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
Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions
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 (e.g. timesheets, metrics, office and travel expense claims)
Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trials
Experience in Phase I Oncology experience advantageous
Degree in a life science, nursing qualification or relevant experience
Competent in written and oral English
Strong understanding of the cross functional activities
Leadership skills
Strong customer focus
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Effective time management in order to meet daily metrics or team objectives
Personal skills that include : ability to take initiative and work independently, ability to successfully work in a team environment, sense of urgency in completing assigned tasks
Excellent interpersonal, oral and written communication skills
Excellent presentation skills
Ability to travel as required
