Key Responsibilities：
•Line management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, employee counselling fstaff.
• Participate in managing the resource availability fthe assigned
staff/region, ensuring projects are suitably resourced staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
• Provide expert operational oversight guidance to support
prioritization of activities, review monitthe work performed, metric compliance, development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process new hire on boarding. Proactively works to ensure staff retention turnover rates remain within expected levels.
• Ensures quality adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) compliance with federal local guidelines ICH GCPs. Ensures all staff follows required training completes the required documentation. Provides regular updates to management
accordingly.
• Ensure staff performance on studies correct deficiencies as
identified by staff, clients, auditors. May provide business development support.
• May conduct various types of sign off assessment visits to ensure Clinical Operations on-site performance. Develop oversee training
plans to address performance deficiencies.
•ganizes chairs clinical staff meetings at regular intervals.
Manages issues provides follow up faction items requiring
resolution.
• May participate in business development proposals, defense meetings proposal development.
• Coach mententry level Line Manager
Preferred Experiences Skills:
• Minimum of 6 years of progressive experience in clinical research 1 year in line manage position preferred.
• Extensive knowledge of GCP/ICH guidelines other applicable
regulatory requirement.
• Excellent communication, presentation, interpersonal, change
management skills, both written spoken, with an ability to inform,
influence, convince, persuade.
• Strong time management, technicalganizational skills. Ability to work independently within a team environment.
• Knowledge of basic financial concepts as related to forecasting and
budgeting. Understands project budgets.
• Must demonstrate good computer skills be able to embrace new
technologies.
• Ability to travel as necessary (up to 25%)
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