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The Senior Clinical Operations Leader is responsible for overseeing the functional team members and their activities across all geographies, liaising with the sponsor, project leadership, site management and all other related internal and external stake holders to ensure that the Clinical Operations deliverables are met on time, within budget, and with quality. The Senior Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy and plan within the project and can competently and independently lead the clinical team.
Job Responsibility:
Oversee the functional team members and their activities across all geographies
Liaise with the sponsor, project leadership, site management and all other related internal and external stake holders
Ensure Clinical Operations deliverables are met on time, within budget, and with quality
Overall accountability for the execution of the clinical operations strategy and plan
Act as a role model and/or coach for the team
Effectively communicate with internal and external customers as well as third party vendors
Build trusted partnerships with sponsor and other functional leaders
Develop and recommend strategic solutions to internal team and sponsors
Oversee and/ or manage study start-up activities
Provide inputs to project tools and study plans
Provide leadership and direction to project team members
Own and drive study timelines, patient recruitment and retention, and data cleaning
Proactively plan and manage large/complex or multiple projects
Liaise with vendors to support clinical activities
Oversee maintenance and quality check of TMF
Manage the clinical portion of the project according to the contracted scope
Monitor cost drivers and actively seeks ways to optimize resources
Participate in or lead sponsor, investigator, and team meetings
Prepare, participate in, and follow up on audits / inspections
Collaborate with project team and relevant vendors on database lock activities
Ensure all clinical administrative closeout procedures are completed
Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs
Responsible for reviewing site qualification, initiation, monitoring, and close-out visit reports
Requirements:
Diabetes experience required
Strong command of written and spoken English language
Proven clinical experience or management experience in healthcare, clinical research, or contract research organization
Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials
Substantial experience in Coordination of Clinical Trials – preferably as Clinical Operations Leader or proven experience in a similar role
Strong understanding of cross-functional activities
Degree in a life science, nursing qualification or relevant clinical and or clinical management experience